LiftActiv B3 in Post Inflammatory Hyperpigmentation (PIHP)

Study Overview
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Brief Summary
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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)

Official Title
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Evaluation of the Depigmenting Effect of Liftactiv B3 Serum (Split Face) in Patients With Mild to Moderate Facial Post-acne PIHP for 3 Months

Conditions
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Acne, Post Inflammatory Hyperpigmentation

Intervention / Treatment
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* Drug: Liftactiv B3
* Other: Sunscreen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months. | Other: Sunscreen<br>* Participants will apply a dime size amount of sunscreen to cover the other half of the face.<br>|
| Experimental: Liftactiv B3<br>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. | Drug: Liftactiv B3<br>* Participants will apply a dime size amount of the serum to 1 side of the face.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Inflammatory Hyperpigmentation (PIHP) change | 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. | Baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Investigators Global Assessment (IGA) scale | Pigmentation will also be evaluated clinically using the Physician global assessment IGA defined as none is 0, minimal is 1 or mild disease is 2 within the treatment area. | At baseline, 1 month, 2 months and 3 months | 
| Change in skin condition evaluation scores | 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. | Baseline, 1 month, 2 months and 3 months | 
| Change in Global Efficacy Assessment | 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). | 1 month, 2 months and 3 months | 
| Change in Global tolerance score | 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. | 1 month, 2 months and 3 months | 
| Change in Cosmeticity Questionnaire and Acceptability | 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). | 1 month, 2 months and 3 months | 
| Change in Exposome Questionnaire | Subjects will be questioned about their perceived effects of the investigational product on their skin. Five different answers will be proposed: (0)Fully disagree, disagree partly, no opinion, agree partly, (5) fully agree. | Baseline and 3 months |