LiftActiv B3 in Post Inflammatory Hyperpigmentation (PIHP)

Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05327361
• Other study ID #: 20211099
• Status: Terminated
• Phase: Phase 2
• Start date: March 22, 2022
• Est. completion date: March 6, 2023

Study information

• Verified date: March 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: March 6, 2023
• Est. primary completion date: January 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne
• Hyperpigmentation
• Post Inflammatory Hyperpigmentation

Intervention

Drug:
• Liftactiv B3
Participants will apply a dime size amount of the serum to 1 side of the face.

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

Locations

Country	Name	City	State
United States	University of Miami Hospital	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Vichy Laboratoires

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Exposome Questionnaire	Subjects will be questioned about environmental influences. Count of participants completing questionnaire.	Baseline and 3 months