Trial Outcomes & Findings for A Study to Assess Efficacy and Tolerability of Topical Skincare Products on Psoriasis Patients (NCT NCT06357221)

NCT ID: NCT06357221

Last Updated: 2026-06-09

Results Overview

Body Surface Area is a measure of how much skin is impacted by psoriasis using the following measurement.7 One handprint is equal approximately to 1% of Body Surface Area. A decrease in scores indicated an improvement.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

46 participants

Primary outcome timeframe

Baseline, Week 2, Week 4, Week 8

Results posted on

2026-06-09

Participant Flow

46 subjects met the inclusion and exclusion criteria, and were enrolled in the study.

Participant milestones

Participant milestones
Measure
Skincare Product Treatment
Subjects applied the study products to the area of active lesion twice daily.
Overall Study
STARTED
46
Overall Study
COMPLETED
41
Overall Study
NOT COMPLETED
5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Assess Efficacy and Tolerability of Topical Skincare Products on Psoriasis Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Skincare Product Treatment
n=46 Participants
Subjects applied study products to the area of active lesions twice daily.
Age, Continuous
57.2 Years
STANDARD_DEVIATION 15.9 • n=20 Participants
Sex: Female, Male
Female
24 Participants
n=20 Participants
Sex: Female, Male
Male
22 Participants
n=20 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=20 Participants
Race (NIH/OMB)
Asian
1 Participants
n=20 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=20 Participants
Race (NIH/OMB)
Black or African American
16 Participants
n=20 Participants
Race (NIH/OMB)
White
24 Participants
n=20 Participants
Race (NIH/OMB)
More than one race
5 Participants
n=20 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=20 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants
n=20 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
41 Participants
n=20 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=20 Participants
Region of Enrollment
United States
46 Participants
n=20 Participants

PRIMARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8

Population: Intention to treat population was used for primary outcome.

Body Surface Area is a measure of how much skin is impacted by psoriasis using the following measurement.7 One handprint is equal approximately to 1% of Body Surface Area. A decrease in scores indicated an improvement.

Outcome measures

Outcome measures
Measure
Skincare Product Treatment
n=46 Participants
Subjects applied the study products to the area of active lesions twice daily.
Change in Psoriatic Body Surface Area Compared to Baseline
Week 8
5.1 BSA %
Standard Deviation 5.55
Change in Psoriatic Body Surface Area Compared to Baseline
Baseline
9.3 BSA %
Standard Deviation 10.1
Change in Psoriatic Body Surface Area Compared to Baseline
Week 2
7.55 BSA %
Standard Deviation 6.89
Change in Psoriatic Body Surface Area Compared to Baseline
Week 4
7.49 BSA %
Standard Deviation 11.34

PRIMARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8

Population: Intention to treat population is used for primary outcome.

Target lesion severity was measured by the Target Lesion Severity Score. Target Lesion Severity Score assessed erythema, induration, and scaling separately on a scale of 0-8, with 0 meaning no evidence of the parameter and 8 meaning very severe presence of the parameter. Target Lesion Severity Score was calculated as cumulative total of all 3 parameters, which a maximum score of 24 (8 x 3) and minimum score of 0. Total scale range is 0-24, where higher scores are worse outcomes. A decrease in scores indicated an improvement.

Outcome measures

Outcome measures
Measure
Skincare Product Treatment
n=46 Participants
Subjects applied the study products to the area of active lesions twice daily.
Change in Target Lesion Severity Compared to Baseline
Baseline
10.85 Score on a scale
Standard Deviation 3.67
Change in Target Lesion Severity Compared to Baseline
Week 2
7.24 Score on a scale
Standard Deviation 3.59
Change in Target Lesion Severity Compared to Baseline
Week 4
5.34 Score on a scale
Standard Deviation 4.07
Change in Target Lesion Severity Compared to Baseline
Week 8
3.51 Score on a scale
Standard Deviation 3

PRIMARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8

Population: Intention to treat population was used for primary outcome.

Physician Global Assessment assessed overall severity of psoriasis on a scale of 0 to 5, with 0 meaning no presence of psoriasis and 5 meaning very severe presence of psoriasis. A decrease in scores indicated an improvement.

Outcome measures

Outcome measures
Measure
Skincare Product Treatment
n=46 Participants
Subjects applied the study products to the area of active lesions twice daily.
Change of Physician Global Assessment Compared to Baseline
Baseline
2.67 Score on a scale
Standard Deviation 0.7
Change of Physician Global Assessment Compared to Baseline
Week 2
2.36 Score on a scale
Standard Deviation 0.79
Change of Physician Global Assessment Compared to Baseline
Week 4
1.73 Score on a scale
Standard Deviation 0.87
Change of Physician Global Assessment Compared to Baseline
Week 8
1.37 Score on a scale
Standard Deviation 0.83

PRIMARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8

Population: This outcome measure was only performed at one study site only; therefore, the number of participants was representative of the selected study site and less than the total study participant number. Intention to treat population was used for primary outcome.

Macroscopic imaging was performed using Visioscan® VC 20plus to take an image of the target lesion. The Visioscan software was used to calculate the analyze the images for skin scaliness (a decrease in values indicates an improvement in roughness).

Outcome measures

Outcome measures
Measure
Skincare Product Treatment
n=20 Participants
Subjects applied the study products to the area of active lesions twice daily.
Change in Skin Scaliness Measured by Macroscopic Imaging
Week 4
5.52 Pixels
Standard Deviation 4.26
Change in Skin Scaliness Measured by Macroscopic Imaging
Baseline
10.77 Pixels
Standard Deviation 4.92
Change in Skin Scaliness Measured by Macroscopic Imaging
Week 2
6.78 Pixels
Standard Deviation 3.63
Change in Skin Scaliness Measured by Macroscopic Imaging
Week 8
5.71 Pixels
Standard Deviation 4.36

PRIMARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8

Population: This outcome measure was only performed at one study site only; therefore, the number of participants was representative of the selected study site and less than the total study participant number. Intention to treat population was used for primary outcome.

Macroscopic imaging was performed using Visioscan® VC 20plus to take an image of the target lesion. The Visioscan software was used to calculate the analyze the images for skin smoothness (a decrease in values indicates an improvement in skin smoothness).

Outcome measures

Outcome measures
Measure
Skincare Product Treatment
n=20 Participants
Subjects applied the study products to the area of active lesions twice daily.
Change in Skin Smoothness Measured by Macroscopic Imaging
Baseline
596.43 Pixels
Standard Deviation 192.39
Change in Skin Smoothness Measured by Macroscopic Imaging
Week 2
394.49 Pixels
Standard Deviation 169.99
Change in Skin Smoothness Measured by Macroscopic Imaging
Week 4
376.72 Pixels
Standard Deviation 205.51
Change in Skin Smoothness Measured by Macroscopic Imaging
Week 8
353.95 Pixels
Standard Deviation 192.12

PRIMARY outcome

Timeframe: Week 2

Subjects were asked about their perception, satisfaction, and preference with each study treatment using a self-assessment questionnaire. Questionnaires were tabulated; and the number of all response options was reported for each question and time point. Favorable responses (i.e., strongly agree and agree, yes), neutral responses (i.e., neither agree nor disagree, no difference), and unfavorable responses (i.e., strongly disagree and disagree, no) were tabulated as appropriate. Number of participants with favorable responses was provided for each question.

Outcome measures

Outcome measures
Measure
Skincare Product Treatment
n=42 Participants
Subjects applied the study products to the area of active lesions twice daily.
Subject Treatment Satisfaction
Subjects reported the cleanser left their skin feeling clean
39 Participants with favorable responses
Subject Treatment Satisfaction
Subjects reported the cleanser didn't irritate their skin
38 Participants with favorable responses
Subject Treatment Satisfaction
Subjects report this cleanser didn't dry their skin out
40 Participants with favorable responses
Subject Treatment Satisfaction
Subjects reported their skin felt nourished after using the regimen
39 Participants with favorable responses
Subject Treatment Satisfaction
Subjects reported it was easy to incorporate this skincare regimen into daily prescription routine
40 Participants with favorable responses
Subject Treatment Satisfaction
Subjects reported this moisturizer had helped the lesions feel softer
40 Participants with favorable responses
Subject Treatment Satisfaction
Subjects reported the skin lesions felt smoother since starting this moisturizer
36 Participants with favorable responses
Subject Treatment Satisfaction
Subjects reported their skin looked healthier since starting this moisturizer
33 Participants with favorable responses
Subject Treatment Satisfaction
Subjects reported the moisturizer kept their skin feeling hydrated throughout the day
38 Participants with favorable responses

PRIMARY outcome

Timeframe: Week 4

Subjects were asked about their perception, satisfaction, and preference with each study treatment using a self-assessment questionnaire. Questionnaires were tabulated; and the number of all response options was reported for each question and time point. Favorable responses (i.e., strongly agree and agree, yes), neutral responses (i.e., neither agree nor disagree, no difference), and unfavorable responses (i.e., strongly disagree and disagree, no) were tabulated and reported as appropriate. Number of participants with favorable responses was provided for each question.

Outcome measures

Outcome measures
Measure
Skincare Product Treatment
n=41 Participants
Subjects applied the study products to the area of active lesions twice daily.
Subject Treatment Satisfaction
Subjects reported their skin was less dry and cracked
36 Participants with favorable responses
Subject Treatment Satisfaction
Subjects reported they worried less about their skin since starting the regimen
34 Participants with favorable responses
Subject Treatment Satisfaction
Subjects reported the products worked well with their prescription treatment as a complete regimen
37 Participants with favorable responses
Subject Treatment Satisfaction
Subjects reported this moisturizer helped smooth out their skin's rough texture
39 Participants with favorable responses
Subject Treatment Satisfaction
Subjects reported their skin appeared healthier-looking since starting this moisturizer
38 Participants with favorable responses
Subject Treatment Satisfaction
Subjects reported the skin lesions felt much softer since starting this moisturizer
39 Participants with favorable responses
Subject Treatment Satisfaction
Subjects reported this moisturizer had helped the lesions feel more hydrated
40 Participants with favorable responses
Subject Treatment Satisfaction
Subjects reported the skin lesions looked less flaky since starting this moisturizer
39 Participants with favorable responses

PRIMARY outcome

Timeframe: Week 8

Subjects were asked about their perception, satisfaction, and preference with each study treatment using a self-assessment questionnaire. Questionnaires were tabulated; and the number of all response options was reported for each question and time point. Favorable responses (i.e., strongly agree and agree, yes), neutral responses (i.e., neither agree nor disagree, no difference), and unfavorable responses (i.e., strongly disagree and disagree, no) were tabulated and reported as appropriate. Number of participants with favorable responses was provided for each question.

Outcome measures

Outcome measures
Measure
Skincare Product Treatment
n=41 Participants
Subjects applied the study products to the area of active lesions twice daily.
Subject Treatment Satisfaction
Subjects reported they loved how soft their skin felt
39 Participants with favorable responses
Subject Treatment Satisfaction
Subjects reported the cleanser was gentle for daily use on their psoriasis skin
41 Participants with favorable responses
Subject Treatment Satisfaction
Subjects reported the skin felt the least irritated since starting this skincare regimen
34 Participants with favorable responses
Subject Treatment Satisfaction
Subjects report their skin hadn't felt this great in a long time
37 Participants with favorable responses
Subject Treatment Satisfaction
Subjects reported this was thei favorite skincare regimen
34 Participants with favorable responses
Subject Treatment Satisfaction
Subjects reported this skincare regimen was the perfect choice as part of prescription regimen
36 Participants with favorable responses
Subject Treatment Satisfaction
Subjects reported their skin was at the healthiest-looking state since using this moisturizer
37 Participants with favorable responses
Subject Treatment Satisfaction
Subjects reported this moisturizer helped sooth my sensitive skin
41 Participants with favorable responses
Subject Treatment Satisfaction
Subjects reported the skin lesions had been consistently hydrated since using this moisturizer
39 Participants with favorable responses
Subject Treatment Satisfaction
Subjects reported this moisturizer helped smoothen out the rough, scaly lesions
40 Participants with favorable responses

PRIMARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8

Population: Intention to treat population was used for primary outcome.

Tolerability assessment was performed by the Investigator (parameter: dryness) using a 4-point analog scale (with half-point scores used as necessary to better describe the clinical condition). Investigator graded the degree of irritation of target lesion areas on a scale of 0 to 3, with 0 meaning parameter is not present, and 3 meaning parameter is severely present. A decrease in scores or lack of significant increase indicated tolerability/safety of the treatment products.

Outcome measures

Outcome measures
Measure
Skincare Product Treatment
n=46 Participants
Subjects applied the study products to the area of active lesions twice daily.
Changes in Dryness Compared to Baseline [Tolerability Assessment]
Baseline
2.09 Score on a scale
Standard Deviation 0.72
Changes in Dryness Compared to Baseline [Tolerability Assessment]
Week 2
1.38 Score on a scale
Standard Deviation 0.70
Changes in Dryness Compared to Baseline [Tolerability Assessment]
Week 4
1.07 Score on a scale
Standard Deviation 0.98
Changes in Dryness Compared to Baseline [Tolerability Assessment]
Week 8
0.71 Score on a scale
Standard Deviation 0.81

PRIMARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8

Population: Intention to treat population was used for primary outcome.

Tolerability assessment was performed by subjects (parameters: burning/stinging) using a 4-point analog scale (with half-point scores used as necessary to better describe the clinical condition). subjects graded the degree of irritation of target lesion areas on a scale of 0 to 3, with 0 meaning parameter is not present, and 3 meaning parameter is severely present. A decrease in scores or lack of significant increase indicated tolerability/safety of the treatment products.

Outcome measures

Outcome measures
Measure
Skincare Product Treatment
n=46 Participants
Subjects applied the study products to the area of active lesions twice daily.
Change in Burning/Stinging Compared to Baseline [Tolerability Assessment]
Baseline
1.15 Score on a scale
Standard Deviation 1.05
Change in Burning/Stinging Compared to Baseline [Tolerability Assessment]
Week 2
0.67 Score on a scale
Standard Deviation 0.93
Change in Burning/Stinging Compared to Baseline [Tolerability Assessment]
Week 4
0.27 Score on a scale
Standard Deviation 0.67
Change in Burning/Stinging Compared to Baseline [Tolerability Assessment]
Week 8
0.12 Score on a scale
Standard Deviation 0.51

PRIMARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8

Population: Intention to treat population was used for primary outcome.

Tolerability assessment was performed by subjects (parameters: itching) using a 4-point analog scale (with half-point scores used as necessary to better describe the clinical condition). Subjects graded the degree of irritation of target lesion areas on a scale of 0 to 3, with 0 meaning parameter is not present, and 3 meaning parameter is severely present. A decrease in scores or lack of significant increase indicated tolerability/safety of the treatment products.

Outcome measures

Outcome measures
Measure
Skincare Product Treatment
n=46 Participants
Subjects applied the study products to the area of active lesions twice daily.
Change in Itching Compared to Baseline [Tolerability Assessment]
Baseline
2.04 Score on a scale
Standard Deviation 0.97
Change in Itching Compared to Baseline [Tolerability Assessment]
Week 2
0.98 Score on a scale
Standard Deviation 0.98
Change in Itching Compared to Baseline [Tolerability Assessment]
Week 4
0.68 Score on a scale
Standard Deviation 0.93
Change in Itching Compared to Baseline [Tolerability Assessment]
Week 8
0.29 Score on a scale
Standard Deviation 0.64

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: Intention to treat population was used for secondary outcome.

Subjects were asked about their life quality by completing a Quality of Life questionnaire of 10 questions. Each question is scored from 0-3, with 0 being "not at all" or "not relevant" and 3 being "very much". All scores were summed to determine the Dermatology Quality of Life Index with score range 0-30: 0-1 (no effect at all on patient's life), 2-5 (small effect), 6-10 (moderate effect), 11-20 (very large effect), 21-30 (extremely large effect). A decrease in score totals from baseline to Week 8 indicated an improvement. A higher score indicates a greater impairment of quality of life.

Outcome measures

Outcome measures
Measure
Skincare Product Treatment
n=46 Participants
Subjects applied the study products to the area of active lesions twice daily.
Subject Quality of Life Satisfaction
Baseline
9.24 Score on a scale
Standard Deviation 6.77
Subject Quality of Life Satisfaction
Week 8
2.85 Score on a scale
Standard Deviation 3.17

Adverse Events

Skincare Product Treatment

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Skincare Product Treatment
n=46 participants at risk
Subjects applied the study products to the area of active lesions twice daily.
Skin and subcutaneous tissue disorders
Itchy
2.2%
1/46 • 8 weeks (i.e., from the study start to the study completion).
Throughout the course of the study, all adverse events were monitored and reported on an adverse event CRF/eCRF without omitting any requested and known information.
Skin and subcutaneous tissue disorders
Burning/Stinging
6.5%
3/46 • 8 weeks (i.e., from the study start to the study completion).
Throughout the course of the study, all adverse events were monitored and reported on an adverse event CRF/eCRF without omitting any requested and known information.

Additional Information

Thu Q. Nguyen, PhD

Galderma

Phone: 8179615495

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place