Trial Outcomes & Findings for LiftActiv B3 in Post Inflammatory Hyperpigmentation (PIHP) (NCT NCT05327361)

Last Updated: 2024-04-03

Results Overview

Post Inflammatory Hyperpigmentation (PIHP) will be evaluated using the post acne hyperpigmentation scale. The total score can range from 6-22 points. Subscales will measure lesion size, lesion intensity, and number of lesions. Subscales are added together to form the total score. Higher values indicate worse hyperpigmentation.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Baseline, 1 month, 2 months and 3 months

Results posted on

2024-04-03

Participant Flow

Every participant enrolled (total 13) received each arm of the study with treatment arm on one side of the face, and the control arm on the other side of the face (which equates to 26 "participants" total for the arms/groups).

Unit of analysis: Half face

Participant milestones

Participant milestones
Measure	All Study Participants Participants will undergo a wash out phase of two weeks where they regularly apply a moisturizer (Hydreane Legere) in the morning and a sunscreen in the morning and at the beginning of the afternoon. On the 3rd week, participants will apply Liftactiv B3 serum daily in the morning before sunscreen and in the evening (two applications daily) on half face for 3 months. Liftactiv B3: Participants will apply a dime size amount of the serum to 1 side of the face. Sunscreen: Participants will apply a dime size amount of sunscreen to cover the other half of the face. Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months.
Overall Study STARTED	13 26
Overall Study Liftactiv B3	13 26
Overall Study Control Group	13 26
Overall Study COMPLETED	9 18
Overall Study NOT COMPLETED	4 8

Reasons for withdrawal

Reasons for withdrawal
Measure	All Study Participants Participants will undergo a wash out phase of two weeks where they regularly apply a moisturizer (Hydreane Legere) in the morning and a sunscreen in the morning and at the beginning of the afternoon. On the 3rd week, participants will apply Liftactiv B3 serum daily in the morning before sunscreen and in the evening (two applications daily) on half face for 3 months. Liftactiv B3: Participants will apply a dime size amount of the serum to 1 side of the face. Sunscreen: Participants will apply a dime size amount of sunscreen to cover the other half of the face. Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months.
Overall Study Lost to Follow-up	4

Baseline Characteristics

LiftActiv B3 in Post Inflammatory Hyperpigmentation (PIHP)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liftactiv B3 and Control Group n=13 Participants Participants will undergo a wash out phase of two weeks where they regularly apply a moisturizer (Hydreane Legere) in the morning and a sunscreen in the morning and at the beginning of the afternoon. On the 3rd week, participants will apply Liftactiv B3 serum daily in the morning before sunscreen and in the evening (two applications daily) on half face for 3 months. Liftactiv B3: Participants will apply a dime size amount of the serum to 1 side of the face. Sunscreen: Participants will apply a dime size amount of sunscreen to cover the other half of the face. Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months.will apply a dime size amount of sunscreen to cover the other half of the face.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	10 Participants n=99 Participants
Sex: Female, Male Male	3 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	4 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	3 Participants n=99 Participants
Race (NIH/OMB) White	5 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline, 1 month, 2 months and 3 months

Population: Only 9 participants completed the the follow up (1 month, 2 month, and 3 month) visit assessments.

Outcome measures

Outcome measures
Measure	Control Group n=9 Participants Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months. Sunscreen: Participants will apply a dime size amount of sunscreen to cover the other half of the face.	Liftactiv B3 n=9 Participants Participants will undergo a wash out phase of two weeks where they regularly apply a moisturizer (Hydreane Legere) in the morning and a sunscreen in the morning and at the beginning of the afternoon. On the 3rd week, participants will apply Liftactiv B3 serum daily in the morning before sunscreen and in the evening (two applications daily) on half face for 3 months. Liftactiv B3: Participants will apply a dime size amount of the serum to 1 side of the face.
Post Inflammatory Hyperpigmentation (PIHP) Change Baseline	8.25 score on a scale Standard Deviation 2.38	8.25 score on a scale Standard Deviation 2.37
Post Inflammatory Hyperpigmentation (PIHP) Change 1 month	6.56 score on a scale Standard Deviation 1.13	6.56 score on a scale Standard Deviation 1.13
Post Inflammatory Hyperpigmentation (PIHP) Change 2 months	6.44 score on a scale Standard Deviation 1.33	6.44 score on a scale Standard Deviation 1.33
Post Inflammatory Hyperpigmentation (PIHP) Change 3 months	6 score on a scale Standard Deviation 0	6 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Baseline, 1 month, 2 months and 3 months

Population: Only 12 participants completed the follow up (1 month, 2 month, and 3 month) visit assessments.

Pigmentation will also be evaluated clinically using the Physician global assessment IGA defined as clear is 0, almost clear is 1, mild is 2, moderate is 3, severe is 4, and every severe is 5 within the treatment area.

Outcome measures

Outcome measures
Measure	Control Group n=9 Participants Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months. Sunscreen: Participants will apply a dime size amount of sunscreen to cover the other half of the face.	Liftactiv B3 n=9 Participants Participants will undergo a wash out phase of two weeks where they regularly apply a moisturizer (Hydreane Legere) in the morning and a sunscreen in the morning and at the beginning of the afternoon. On the 3rd week, participants will apply Liftactiv B3 serum daily in the morning before sunscreen and in the evening (two applications daily) on half face for 3 months. Liftactiv B3: Participants will apply a dime size amount of the serum to 1 side of the face.
Change in the Investigators Global Assessment (IGA) Scale Baseline	2.08 units on a scale Standard Deviation 0.79	1.92 units on a scale Standard Deviation 0.79
Change in the Investigators Global Assessment (IGA) Scale 1 month	1.33 units on a scale Standard Deviation 0.5	1.22 units on a scale Standard Deviation 0.44
Change in the Investigators Global Assessment (IGA) Scale 2 months	1.33 units on a scale Standard Deviation 0.87	1.33 units on a scale Standard Deviation 0.87
Change in the Investigators Global Assessment (IGA) Scale 3 months	1.33 units on a scale Standard Deviation 0.87	1.44 units on a scale Standard Deviation 0.88

SECONDARY outcome

Timeframe: Baseline, 1 month, 2 months and 3 months

Population: Only 9 participants completed the the follow up (to 3 month) visit assessments. Oversight of translation from protocol to CRF caused this data to not be collected at 1month and 2 month time points.

Clinical evaluation of skin condition on subject's face which includes deep wrinkles, fine lines, skin tone, skin texture, radiance and skin elasticity will be evaluated using a 10 point Likert Scale. Each of these conditions will use the same Likert Scale from 0 to 9 with the higher score indicating more severe/worse symptoms.

Outcome measures

Outcome measures
Measure	Control Group n=9 Participants Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months. Sunscreen: Participants will apply a dime size amount of sunscreen to cover the other half of the face.	Liftactiv B3 n=9 Participants Participants will undergo a wash out phase of two weeks where they regularly apply a moisturizer (Hydreane Legere) in the morning and a sunscreen in the morning and at the beginning of the afternoon. On the 3rd week, participants will apply Liftactiv B3 serum daily in the morning before sunscreen and in the evening (two applications daily) on half face for 3 months. Liftactiv B3: Participants will apply a dime size amount of the serum to 1 side of the face.
Change in Skin Condition Evaluation Scores 3 months	4.44 units on a scale Standard Deviation 1.57	2.67 units on a scale Standard Deviation 1.33
Change in Skin Condition Evaluation Scores Baseline	5.33 units on a scale Standard Deviation 1.33	5.33 units on a scale Standard Deviation 1.33

SECONDARY outcome

Timeframe: 1 month, 2 months, and 3 months

Global efficacy of the treatment evaluated at each visit by the patient. The measure of the global efficacy will be realized according to the Global efficacy scale which ranges from nil to excellent which will be measured from 0 (equals nil) to 4 (equals excellent).

Outcome measures

Outcome measures
Measure	Control Group n=9 Participants Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months. Sunscreen: Participants will apply a dime size amount of sunscreen to cover the other half of the face.	Liftactiv B3 Participants will undergo a wash out phase of two weeks where they regularly apply a moisturizer (Hydreane Legere) in the morning and a sunscreen in the morning and at the beginning of the afternoon. On the 3rd week, participants will apply Liftactiv B3 serum daily in the morning before sunscreen and in the evening (two applications daily) on half face for 3 months. Liftactiv B3: Participants will apply a dime size amount of the serum to 1 side of the face.
Change in Global Efficacy Assessment 3 months	2.56 score on a scale Standard Error 0.68	—

SECONDARY outcome

Timeframe: 1 month, 2 months, and 3 months

Clinical tolerance global score will be assessed, on the treated area, at each visit using first a 4-point skin reaction scale which ranges from 0 which indicates no evidence of local intolerance and 4 indicates very severe signs or symptoms of intolerance.

Outcome measures

Outcome measures
Measure	Control Group n=9 Participants Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months. Sunscreen: Participants will apply a dime size amount of sunscreen to cover the other half of the face.	Liftactiv B3 Participants will undergo a wash out phase of two weeks where they regularly apply a moisturizer (Hydreane Legere) in the morning and a sunscreen in the morning and at the beginning of the afternoon. On the 3rd week, participants will apply Liftactiv B3 serum daily in the morning before sunscreen and in the evening (two applications daily) on half face for 3 months. Liftactiv B3: Participants will apply a dime size amount of the serum to 1 side of the face.
Change in Global Tolerance Score 3 months	0.11 score on a scale Standard Deviation 0.31	—

SECONDARY outcome

Timeframe: 1 month, 2 months, and 3 months

Subjects will be questioned about their perceived effects of the investigational product on their skin. The cosmeticity questionnaire is a 5 point scale (1-fully disagree; 2-disagree partly; 3-no opinion; 4-agree partly; 5-fully agree).

Outcome measures

Outcome measures
Measure	Control Group n=9 Participants Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months. Sunscreen: Participants will apply a dime size amount of sunscreen to cover the other half of the face.	Liftactiv B3 Participants will undergo a wash out phase of two weeks where they regularly apply a moisturizer (Hydreane Legere) in the morning and a sunscreen in the morning and at the beginning of the afternoon. On the 3rd week, participants will apply Liftactiv B3 serum daily in the morning before sunscreen and in the evening (two applications daily) on half face for 3 months. Liftactiv B3: Participants will apply a dime size amount of the serum to 1 side of the face.
Change in Cosmeticity Questionnaire and Acceptability 3 months	4.39 score on a scale Standard Deviation 0.5	—

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Exposome questionnaire only consists of descriptive questions (used for data collection only), so reported here as number of participants that completed questionnaire.

Subjects will be questioned about environmental influences. Count of participants completing questionnaire.

Outcome measures

Outcome measures
Measure	Control Group n=9 Participants Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months. Sunscreen: Participants will apply a dime size amount of sunscreen to cover the other half of the face.	Liftactiv B3 Participants will undergo a wash out phase of two weeks where they regularly apply a moisturizer (Hydreane Legere) in the morning and a sunscreen in the morning and at the beginning of the afternoon. On the 3rd week, participants will apply Liftactiv B3 serum daily in the morning before sunscreen and in the evening (two applications daily) on half face for 3 months. Liftactiv B3: Participants will apply a dime size amount of the serum to 1 side of the face.
Exposome Questionnaire 3 months	9 Participants	—
Exposome Questionnaire Baseline	9 Participants	—

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Liftactiv B3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Enzo Berardesca

University of Miami

Phone: 3052434472

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place