LiftActiv B3 in Post Inflammatory Hyperpigmentation (PIHP)

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ClinicalTrials.gov Identifier: NCT05327361

Recruitment Status : Terminated (Enrollment timeline ended)

First Posted : April 14, 2022

Last Update Posted : May 6, 2023

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Vichy Laboratoires

Information provided by (Responsible Party):

Leigh Nattkemper, University of Miami

Tracking Information

First Submitted Date ^ICMJE

March 14, 2022

First Posted Date ^ICMJE

April 14, 2022

Last Update Posted Date

May 6, 2023

Actual Study Start Date ^ICMJE

March 22, 2022

Actual Primary Completion Date

January 17, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

LiftActiv B3 in Post Inflammatory Hyperpigmentation (PIHP)

Official Title ^ICMJE

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

Brief 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)

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Acne
Post Inflammatory Hyperpigmentation

Intervention ^ICMJE

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.

Study Arms ^ICMJE

Active Comparator: Control Group
Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months.

Intervention: Other: Sunscreen
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.

Intervention: Drug: Liftactiv B3

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Actual Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Actual Study Completion Date ^ICMJE

March 6, 2023

Actual Primary Completion Date

January 17, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 50 Years (Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT05327361

Other Study ID Numbers ^ICMJE

20211099

Has Data Monitoring Committee

U.S. FDA-regulated Product

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

IPD Sharing Statement ^ICMJE

Plan to Share IPD:

Current Responsible Party

Leigh Nattkemper, University of Miami

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

University of Miami

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Vichy Laboratoires

Investigators ^ICMJE

Not Provided

PRS Account

University of Miami

Verification Date

May 2023

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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