LiftActiv B3 in Post Inflammatory Hyperpigmentation (PIHP)

University of Miami

Status and phase: Terminated; Phase 2

Conditions: Acne; Post Inflammatory Hyperpigmentation

Treatments: Other: Sunscreen; Drug: Liftactiv B3

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05327361

20211099

Details and patient eligibility

About

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)

Enrollment: 13 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Control Group

Active Comparator group

Description:

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

Treatment:

Other: Sunscreen

Liftactiv B3

Experimental group

Description:

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.

Treatment:

Drug: Liftactiv B3