LiftActiv B3 in Post Inflammatory Hyperpigmentation (PIHP)

NCT ID: NCT05327361

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-22
• Study Completion Date: 2023-03-06

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)

Conditions

Acne; Post Inflammatory Hyperpigmentation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Group

Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months.

Group Type: ACTIVE_COMPARATOR

Sunscreen

Intervention Type: OTHER

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.

Group Type: EXPERIMENTAL

Liftactiv B3

Intervention Type: DRUG

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

Interventions

Liftactiv B3

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

Intervention Type: DRUG

Sunscreen

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vichy Laboratoires

INDUSTRY

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Leigh Nattkemper

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Miami Hospital

Miami, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20211099

Identifier Type: -

Identifier Source: org_study_id