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LiftActiv B3 in Post Inflammatory Hyperpigmentation (PIHP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05327361
Recruitment Status : Terminated (Enrollment timeline ended)
First Posted : April 14, 2022
Last Update Posted : May 6, 2023
Sponsor:
Collaborator:
Vichy Laboratoires
Information provided by (Responsible Party):
Leigh Nattkemper, University of Miami

Study Description
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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)

Condition or disease Intervention/treatment Phase
Acne Post Inflammatory Hyperpigmentation Drug: Liftactiv B3 Other: Sunscreen Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Completion Date : March 6, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sun Exposure

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control Group
Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months.
 Other: Sunscreen
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).


  4. 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.

  5. 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).


  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Florida
University of Miami Hospital
Miami, Florida, United States, 33125
Sponsors and Collaborators
University of Miami
Vichy Laboratoires
More Information
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Responsible Party: Leigh Nattkemper, Research Assistant Professor, University of Miami
ClinicalTrials.gov Identifier: NCT05327361    
Other Study ID Numbers: 20211099
First Posted: April 14, 2022    Key Record Dates
Last Update Posted: May 6, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Sunscreening Agents
 Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Dermatologic Agents