LiftActiv B3 in Post Inflammatory Hyperpigmentation (PIHP)

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

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 Overview

• Status: Terminated
• Conditions: Acne; Post Inflammatory Hyperpigmentation
• Intervention / Treatment: Other: Sunscreen; Drug: Liftactiv B3

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33125
      • University of Miami Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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, 1 month, 2 months and 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 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.	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
Exposome Questionnaire	Subjects will be questioned about environmental influences. Count of participants completing questionnaire.	Baseline and 3 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Vichy Laboratoires

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2022
• Primary Completion (Actual): January 17, 2023
• Study Completion (Actual): March 6, 2023

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hyperpigmentation; Physiological Effects of Drugs; Protective Agents; Dermatologic Agents; Radiation-Protective Agents; Sunscreening Agents
• Other Study ID Numbers: 20211099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No