LiftActiv B3 in Post Inflammatory Hyperpigmentation (PIHP)
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|ClinicalTrials.gov Identifier: NCT05327361|
Recruitment Status : Suspended (Enrollment timeline ended)
First Posted : April 14, 2022
Last Update Posted : March 8, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Acne Post Inflammatory Hyperpigmentation||Drug: Liftactiv B3 Other: Sunscreen||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 22, 2022|
|Actual Primary Completion Date :||January 17, 2023|
|Estimated Study Completion Date :||May 1, 2023|
Active Comparator: Control Group
Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months.
Participants will apply a dime size amount of sunscreen to cover the other half of the face.
Experimental: 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.
Drug: Liftactiv B3
Participants will apply a dime size amount of the serum to 1 side of the face.
- Post Inflammatory Hyperpigmentation (PIHP) change [ Time Frame: Baseline to 3 months ]
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.
- Change in the Investigators Global Assessment (IGA) scale [ Time Frame: At baseline, 1 month, 2 months and 3 months ]Pigmentation will also be evaluated clinically using the Physician global assessment IGA defined as none is 0, minimal is 1 or mild disease is 2 within the treatment area.
- Change in skin condition evaluation scores [ Time Frame: Baseline, 1 month, 2 months and 3 months ]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.
- Change in Global Efficacy Assessment [ Time Frame: 1 month, 2 months and 3 months ]
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).
- Change in Global tolerance score [ Time Frame: 1 month, 2 months and 3 months ]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.
- Change in Cosmeticity Questionnaire and Acceptability [ Time Frame: 1 month, 2 months and 3 months ]
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).
- Change in Exposome Questionnaire [ Time Frame: Baseline and 3 months ]Subjects will be questioned about their perceived effects of the investigational product on their skin. Five different answers will be proposed: (0)Fully disagree, disagree partly, no opinion, agree partly, (5) fully agree.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 50 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05327361
|United States, Florida|
|University of Miami Hospital|
|Miami, Florida, United States, 33125|
|Responsible Party:||Leigh Nattkemper, Research Assistant Professor, University of Miami|
|Other Study ID Numbers:||
|First Posted:||April 14, 2022 Key Record Dates|
|Last Update Posted:||March 8, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
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