Clinical trial

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

Name
20211099
Description
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)
Trial arms
Trial start
2022-03-22
Estimated PCD
2023-01-17
Trial end
2023-03-06
Status
Terminated
Phase
Early phase I
Treatment
Liftactiv B3
Participants will apply a dime size amount of the serum to 1 side of the face.
Arms:
Liftactiv B3
Sunscreen
Participants will apply a dime size amount of sunscreen to cover the other half of the face.
Arms:
Control Group
Size
13
Primary endpoint
Post Inflammatory Hyperpigmentation (PIHP) Change
Baseline, 1 month, 2 months and 3 months
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 13, 'type': 'ACTUAL'}}
Updated at
2024-04-03

1 organization

1 product

2 indications

Indication
Acne