LiftActiv B3 in Post Inflammatory Hyperpigmentation (PIHP)

Phase 2

Terminated

Conditions: Post Inflammatory Hyperpigmentation
Acne

Interventions: Other: Sunscreen
Drug: Liftactiv B3

Registration Number: NCT05327361

Lead Sponsor: University of Miami

Brief Summary: The purpose of this research study is to measure the depigmenting effect of a serum product called Liftactiv B3 in patients with mild to moderate facial PIHP (Post Inflammatory Hyper Pigmentation)

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 13

Inclusion Criteria

Multiethnic subjects
18 to 50 YO
Phototype III-VI
All skin types
50% with sensitive skin (declarative)
Symmetrical mild to moderate facial post-acne PIHP lesions with IGA scale
Mild active acne (less than 10 retention and 5 inflammatory lesions)
Agreeing not to change their lifestyle during the study period.
Capable of reading the documents presented to them, of adhering to the study regulations and accepting the limitations.
Available to follow the study
Agreeing to participate and having signed the informed consent

Exclusion Criteria

Moderate to severe active acne
Patients under topical or systemic retinoids
Patients under systemic immunosuppressants
Patients under active treatment of PIHP (including topicals or procedures) within the last 3 months
Patients treated with facial procedures within the last 3 months
Pregnancy
Patient with a recent change in contraception (since less than 6 months)
Known allergy to any component of tested product
Not presenting with the conditions needed to comply with the protocol.
Unable to give their informed consent
Not available to follow the study in its entirety

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Sunscreen	Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months.
Liftactiv B3	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.

Primary Outcome Measures

Name	Time	Method
Post Inflammatory Hyperpigmentation (PIHP) Change	Baseline, 1 month, 2 months and 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Global Efficacy Assessment	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).
Change in the Investigators Global Assessment (IGA) Scale	Baseline, 1 month, 2 months and 3 months	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.
Change in Skin Condition Evaluation Scores	Baseline, 1 month, 2 months and 3 months	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.
Exposome Questionnaire	Baseline and 3 months	Subjects will be questioned about environmental influences. Count of participants completing questionnaire.
Change in Cosmeticity Questionnaire and Acceptability	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).
Change in Global Tolerance Score	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.