LiftActiv B3 in Post Inflammatory Hyperpigmentation (PIHP)

Phase 2TerminatedNCT05327361

University of Miami13 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acne Post Inflammatory Hyperpigmentation

Interventions

Liftactiv B3DRUG

Participants will apply a dime size amount of the serum to 1 side of the face.

SunscreenOTHER

Participants will apply a dime size amount of sunscreen to cover the other half of the face.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Miami Hospital

Miami, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 1 month, 2 months and 3 months

Secondary Outcomes

Change in the Investigators Global Assessment (IGA) Scale

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.

Time frame: 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.

Time frame: 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).

Time frame: 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.

Data from ClinicalTrials.gov

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