Trial Outcomes & Findings for A Study to Assess the Local Cutaneous and Ocular Tolerance of Three Developmental Facial Skin-care Formulations. (NCT NCT04557371)

Last Updated: 2022-04-22

Results Overview

The clinically relevant positive outcome for cutaneous irritation was defined as the number of participants who experienced an increase in total cutaneous irritation score at Day 21 versus Baseline that was deemed clinically-relevant by the examiner. The dermatologist assessment of signs and symptoms of cutaneous irritation total score was calculated as the sum of the individual cutaneous response attributes (erythema, dryness, scaling, and edema). Each attribute was assessed on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Total possible score range was 0 to 12 where higher value indicated more cutaneous irritation.

Recruitment status

COMPLETED

Study phase

Target enrollment

150 participants

Primary outcome timeframe

Day 21

Results posted on

2022-04-22

Participant Flow

The study was conducted at single center in Germany.

A total of 286 participants were screened of which 150 participants were enrolled and allocated to a randomized treatment. A total of 147 participants completed the study.

Participant milestones

Participant milestones
Measure	Developmental Serum The first topical application of the developmental serum was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental serum at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental serum was performed at home on the morning of the final visit.	Developmental Lotion The first topical application of the developmental lotion was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental lotion at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental lotion was performed at home on the morning of the final visit.	Developmental Cream The first topical application of the developmental cream was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental cream at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental cream was performed at home on the morning of the final visit.
Overall Study STARTED	50	49	51
Overall Study COMPLETED	49	47	51
Overall Study NOT COMPLETED	1	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Developmental Serum The first topical application of the developmental serum was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental serum at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental serum was performed at home on the morning of the final visit.	Developmental Lotion The first topical application of the developmental lotion was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental lotion at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental lotion was performed at home on the morning of the final visit.
Overall Study Covid-19-related	0	1
Overall Study Withdrawal by Subject	0	1
Overall Study Adverse Event	1	0

Baseline Characteristics

A Study to Assess the Local Cutaneous and Ocular Tolerance of Three Developmental Facial Skin-care Formulations.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Developmental Serum n=50 Participants The first topical application of the developmental serum was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental serum at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental serum was performed at home on the morning of the final visit.	Developmental Lotion n=49 Participants The first topical application of the developmental lotion was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental lotion at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental lotion was performed at home on the morning of the final visit.	Developmental Cream n=51 Participants The first topical application of the developmental cream was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental cream at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental cream was performed at home on the morning of the final visit.	Total n=150 Participants Total of all reporting groups
Age, Continuous	48.5 Years STANDARD_DEVIATION 11.06 • n=99 Participants	47.8 Years STANDARD_DEVIATION 11.30 • n=107 Participants	44.6 Years STANDARD_DEVIATION 13.72 • n=206 Participants	47.0 Years STANDARD_DEVIATION 12.15 • n=7 Participants
Sex: Female, Male Female	50 Participants n=99 Participants	49 Participants n=107 Participants	51 Participants n=206 Participants	150 Participants n=7 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	3 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	3 Participants n=7 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	0 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	1 Participants n=7 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	46 Participants n=99 Participants	48 Participants n=107 Participants	50 Participants n=206 Participants	144 Participants n=7 Participants
Race/Ethnicity, Customized Multiple	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants

PRIMARY outcome

Timeframe: Day 21

Population: Safety Population

Outcome measures

Outcome measures
Measure	Developmental Serum n=50 Participants The first topical application of the developmental serum was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental serum at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental serum was performed at home on the morning of the final visit.	Developmental Lotion n=49 Participants The first topical application of the developmental lotion was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental lotion at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental lotion was performed at home on the morning of the final visit.	Developmental Cream n=51 Participants The first topical application of the developmental cream was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental cream at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental cream was performed at home on the morning of the final visit.
Number of Participants Determined by a Dermatologist to Have a Clinically Relevant Positive Outcome for Cutaneous Irritation After 21 Days of Product Use	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 21

Population: Safety Population

The clinically relevant positive outcome for ocular irritation was defined as the number of participants who experienced an increase in total ocular irritation score at Day 21 versus Baseline that was deemed clinically-relevant by the examiner. The ophthalmologist assessment of signs and symptoms of ocular irritation total score was calculated as the sum of the individual ocular response attributes (eczema of the eyelid, conjunctivitis, follicles, and chemosis conjunctivae). Each attribute was assessed on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Total possible score range was 0 to 12 where higher value indicated the most severe condition.

Outcome measures

Outcome measures
Measure	Developmental Serum n=50 Participants The first topical application of the developmental serum was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental serum at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental serum was performed at home on the morning of the final visit.	Developmental Lotion n=49 Participants The first topical application of the developmental lotion was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental lotion at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental lotion was performed at home on the morning of the final visit.	Developmental Cream n=51 Participants The first topical application of the developmental cream was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental cream at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental cream was performed at home on the morning of the final visit.
Number of Participants Determined by an Ophthalmologist to Have a Clinically Relevant Positive Outcome for Ocular Irritation After 21 Days of Product Use	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and 1 to 2 hours post first use

Population: Safety Population.

Participants were asked to self-assess any sensations of cutaneous discomfort for redness, dryness, stinging/burning, itching, and tightness each on separate 0-3 scale, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. These 5 separate assessments were summed to give an overall self-assessed total signs and symptoms of cutaneous irritation score ranging from 0-15. A high score indicates the most severe condition. Change from Baseline in total score at 1 to 2 hours = total cutaneous score at 1 to 2 hours minus total cutaneous score at Baseline. Negative values reflect improvement; a decrease in total score versus Baseline. This reflects a reduction in total signs and symptoms of cutaneous irritation versus Baseline. Positive values reflect worsening; an increase in total score versus Baseline. This reflects an increase in total signs and symptoms of cutaneous irritation versus Baseline. A zero change reflects no change in total score.

Outcome measures

Outcome measures
Measure	Developmental Serum n=50 Participants The first topical application of the developmental serum was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental serum at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental serum was performed at home on the morning of the final visit.	Developmental Lotion n=49 Participants The first topical application of the developmental lotion was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental lotion at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental lotion was performed at home on the morning of the final visit.	Developmental Cream n=51 Participants The first topical application of the developmental cream was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental cream at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental cream was performed at home on the morning of the final visit.
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application Total score= -10	0 Participants	0 Participants	1 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application Total score= -4.5	2 Participants	7 Participants	1 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application Total score= -14	0 Participants	1 Participants	0 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application Total score= -9	0 Participants	1 Participants	0 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application Total score= -8.5	0 Participants	1 Participants	0 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application Total score= -8	0 Participants	0 Participants	1 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application Total score= -7.5	2 Participants	0 Participants	0 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application Total score= -7	1 Participants	0 Participants	0 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application Total score= -6	2 Participants	1 Participants	3 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application Total score= -5.5	0 Participants	0 Participants	2 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application Total score= -5	2 Participants	3 Participants	0 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application Total score= -4	4 Participants	5 Participants	5 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application Total score= -3.5	4 Participants	3 Participants	6 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application Total score= -3	4 Participants	5 Participants	5 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application Total score= -2.5	3 Participants	5 Participants	3 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application Total score= -2	5 Participants	6 Participants	5 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application Total score= -1.5	5 Participants	3 Participants	7 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application Total score= -1	6 Participants	3 Participants	4 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application Total score= -0.5	2 Participants	3 Participants	7 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application Total score= 0	4 Participants	0 Participants	1 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application Total score= 0.5	2 Participants	2 Participants	0 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application Total score= 2	1 Participants	0 Participants	0 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application Total score= 3	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and Day 21

Population: Safety Population. Only those participants with data available at the specified time points were analyzed.

Participants were asked to self-assess any sensations of cutaneous discomfort for redness, dryness, stinging/burning, itching, and tightness each on separate 0-3 scale, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. These 5 separate assessments were summed to give an overall self-assessed total signs and symptoms of cutaneous irritation score ranging from 0-15. A high score indicates the most severe condition. Change from Baseline in total score at Day 21 = total cutaneous score at Day 21 minus total cutaneous score at Baseline. Negative values reflect improvement; a decrease in total score versus Baseline. This reflects a reduction in total signs and symptoms of cutaneous irritation versus Baseline. Positive values reflect worsening; an increase in total score versus Baseline. This reflects an increase in total signs and symptoms of cutaneous irritation versus Baseline. A zero change reflects no change in total score.

Outcome measures

Outcome measures
Measure	Developmental Serum n=49 Participants The first topical application of the developmental serum was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental serum at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental serum was performed at home on the morning of the final visit.	Developmental Lotion n=47 Participants The first topical application of the developmental lotion was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental lotion at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental lotion was performed at home on the morning of the final visit.	Developmental Cream n=51 Participants The first topical application of the developmental cream was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental cream at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental cream was performed at home on the morning of the final visit.
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use Total score= -4	2 Participants	2 Participants	2 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use Total score= -3	2 Participants	5 Participants	6 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use Total score= -14	0 Participants	1 Participants	0 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use Total score= -10.5	1 Participants	0 Participants	0 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use Total score= -10	0 Participants	0 Participants	1 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use Total score= -9	0 Participants	1 Participants	0 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use Total score= -8.5	0 Participants	1 Participants	1 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use Total score= -8	0 Participants	1 Participants	2 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use Total score= -7.5	2 Participants	1 Participants	0 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use Total score= -6.5	3 Participants	0 Participants	1 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use Total score= -6	0 Participants	2 Participants	1 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use Total score= -5.5	1 Participants	1 Participants	2 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use Total score= -5	3 Participants	5 Participants	1 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use Total score= -4.5	2 Participants	1 Participants	1 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use Total score= -3.5	0 Participants	3 Participants	3 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use Total score= -2.5	6 Participants	4 Participants	5 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use Total score= -2	4 Participants	3 Participants	4 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use Total score= -1.5	6 Participants	4 Participants	10 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use Total score= -1	7 Participants	5 Participants	1 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use Total score= -0.5	3 Participants	3 Participants	3 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use Total score= 0	4 Participants	3 Participants	5 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use Total score= 0.5	1 Participants	0 Participants	0 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use Total score= 1	2 Participants	0 Participants	1 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use Total score= 2	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline and 1 to 2 hours post first use

Population: Safety Population

Participants were asked to self-assess any sensations of ocular discomfort for redness, dryness, stinging/burning, and itching each on separate 0-3 scale, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. These 5 separate assessments were summed to give an overall self-assessed total signs and symptoms of ocular discomfort score ranging from 0-12. A high score indicates the most severe condition. Change from Baseline in total score at 1 to 2 hours = total ocular score at 1 to 2 hours minus total ocular score at Baseline. Negative values reflect improvement; a decrease in total score versus Baseline. This reflects a reduction in total signs and symptoms of ocular irritation versus Baseline. Positive values reflect worsening; an increase in total score versus Baseline. This reflects an increase in total signs and symptoms of ocular irritation versus Baseline. A zero change reflects no change in total score.

Outcome measures

Outcome measures
Measure	Developmental Serum n=50 Participants The first topical application of the developmental serum was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental serum at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental serum was performed at home on the morning of the final visit.	Developmental Lotion n=49 Participants The first topical application of the developmental lotion was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental lotion at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental lotion was performed at home on the morning of the final visit.	Developmental Cream n=51 Participants The first topical application of the developmental cream was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental cream at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental cream was performed at home on the morning of the final visit.
Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application Total score= -3	2 Participants	1 Participants	0 Participants
Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application Total score= -2.5	0 Participants	2 Participants	1 Participants
Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application Total score= -2	1 Participants	2 Participants	0 Participants
Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application Total score= -1.5	1 Participants	1 Participants	2 Participants
Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application Total score= -1	2 Participants	4 Participants	6 Participants
Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application Total score= -0.5	7 Participants	7 Participants	4 Participants
Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application Total score= 0	37 Participants	32 Participants	35 Participants
Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application Total score= 0.5	0 Participants	0 Participants	2 Participants
Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application Total score= 1	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline and Day 21

Population: Safety Population. Only those participants with data available at the specified time points were analyzed.

Participants were asked to self-assess any sensations of ocular discomfort for redness, dryness, stinging/burning, and itching each on separate 0-3 scale, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. These 5 separate assessments were summed to give an overall self-assessed total signs and symptoms of ocular discomfort score ranging from 0-12. A high score indicates the most severe condition. Change from Baseline in total score at Day 21 = total ocular score at Day 21 minus total ocular score at Baseline. Negative values reflect improvement; a decrease in total score versus Baseline. This reflects a reduction in total signs and symptoms of ocular irritation versus Baseline. Positive values reflect worsening; an increase in total score versus Baseline. This reflects an increase in total signs and symptoms of ocular irritation versus Baseline. A zero change reflects no change in total score.

Outcome measures

Outcome measures
Measure	Developmental Serum n=49 Participants The first topical application of the developmental serum was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental serum at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental serum was performed at home on the morning of the final visit.	Developmental Lotion n=47 Participants The first topical application of the developmental lotion was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental lotion at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental lotion was performed at home on the morning of the final visit.	Developmental Cream n=51 Participants The first topical application of the developmental cream was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental cream at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental cream was performed at home on the morning of the final visit.
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use Total score= 0.5	2 Participants	5 Participants	4 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use Total score= 1	2 Participants	4 Participants	2 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use Total score= 1.5	1 Participants	0 Participants	0 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use Total score= 2.5	0 Participants	0 Participants	1 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use Total score= 3	0 Participants	1 Participants	0 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use Total score= 4.5	0 Participants	0 Participants	1 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use Total score= 6	1 Participants	0 Participants	0 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use Total score= -5	2 Participants	0 Participants	0 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use Total score= -3	1 Participants	1 Participants	0 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use Total score= -2.5	0 Participants	1 Participants	1 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use Total score= -2	0 Participants	2 Participants	1 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use Total score= -1.5	2 Participants	3 Participants	1 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use Total score= -1	1 Participants	2 Participants	5 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use Total score= -0.5	9 Participants	7 Participants	7 Participants
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use Total score= 0	28 Participants	21 Participants	28 Participants

Adverse Events

Developmental Serum

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Developmental Lotion

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Developmental Cream

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Developmental Serum n=50 participants at risk The first topical application of the developmental serum was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental serum at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental serum was performed at home on the morning of the final visit.	Developmental Lotion n=49 participants at risk The first topical application of the developmental lotion was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental lotion at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental lotion was performed at home on the morning of the final visit.	Developmental Cream n=51 participants at risk The first topical application of the developmental cream was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental cream at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental cream was performed at home on the morning of the final visit.
Nervous system disorders Headache	4.0% 2/50 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	6.1% 3/49 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	3.9% 2/51 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/50 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	4.1% 2/49 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	0.00% 0/51 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.
Skin and subcutaneous tissue disorders Papule	2.0% 1/50 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	0.00% 0/49 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	0.00% 0/51 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.
Skin and subcutaneous tissue disorders Skin oedema	2.0% 1/50 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	0.00% 0/49 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	0.00% 0/51 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.
Infections and infestations Conjunctivitis	2.0% 1/50 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	0.00% 0/49 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	0.00% 0/51 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.
Infections and infestations Conjunctivitis bacterial	2.0% 1/50 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	0.00% 0/49 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	0.00% 0/51 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.
Infections and infestations Nasopharyngitis	0.00% 0/50 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	0.00% 0/49 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	2.0% 1/51 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.
Gastrointestinal disorders Diarrhoea	2.0% 1/50 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	0.00% 0/49 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	0.00% 0/51 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.
Gastrointestinal disorders Dyspepsia	0.00% 0/50 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	2.0% 1/49 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	0.00% 0/51 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/50 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	4.1% 2/49 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	0.00% 0/51 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/50 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	0.00% 0/49 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	2.0% 1/51 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.
Respiratory, thoracic and mediastinal disorders NASAL MUCOSAL DISORDER	2.0% 1/50 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	0.00% 0/49 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	0.00% 0/51 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	2.0% 1/50 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	0.00% 0/49 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	0.00% 0/51 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.
Eye disorders EYE IRRITATION	2.0% 1/50 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	0.00% 0/49 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	0.00% 0/51 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.
Reproductive system and breast disorders DYSMENORRHOEA	0.00% 0/50 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	0.00% 0/49 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.	2.0% 1/51 • From Screening up to Final Visit (Day 21) Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.