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
Organization
University of MiamiProduct
Liftactiv B3Indication
AcneIndication
Post Inflammatory Hyperpigmentation