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LiftActiv B3 in Post Inflammatory Hyperpigmentation (PIHP)

Primary Purpose

Acne, Post Inflammatory Hyperpigmentation

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Liftactiv B3
Sunscreen
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Miami Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Liftactiv B3

Arm Description

Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in the Investigators Global Assessment (IGA) scale
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
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
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
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
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
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.

Full Information

First Posted
March 14, 2022
Last Updated
May 2, 2023
Sponsor
University of Miami
Collaborators
Vichy Laboratoires
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1. Study Identification

Unique Protocol Identification Number
NCT05327361
Brief Title
LiftActiv B3 in Post Inflammatory Hyperpigmentation (PIHP)
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Enrollment timeline ended
Study Start Date
March 22, 2022 (Actual)
Primary Completion Date
January 17, 2023 (Actual)
Study Completion Date
March 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Vichy Laboratoires

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne, Post Inflammatory Hyperpigmentation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months.
Arm Title
Liftactiv B3
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Liftactiv B3
Intervention Description
Participants will apply a dime size amount of the serum to 1 side of the face.
Intervention Type
Other
Intervention Name(s)
Sunscreen
Intervention Description
Participants will apply a dime size amount of sunscreen to cover the other half of the face.
Primary Outcome Measure Information:
Title
Post Inflammatory Hyperpigmentation (PIHP) change
Description
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.
Time Frame
Baseline to 3 months
Secondary Outcome Measure Information:
Title
Change in the Investigators Global Assessment (IGA) scale
Description
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.
Time Frame
At baseline, 1 month, 2 months and 3 months
Title
Change in skin condition evaluation scores
Description
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.
Time Frame
Baseline, 1 month, 2 months and 3 months
Title
Change in Global Efficacy Assessment
Description
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).
Time Frame
1 month, 2 months and 3 months
Title
Change in Global tolerance score
Description
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.
Time Frame
1 month, 2 months and 3 months
Title
Change in Cosmeticity Questionnaire and Acceptability
Description
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).
Time Frame
1 month, 2 months and 3 months
Title
Change in Exposome Questionnaire
Description
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.
Time Frame
Baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

LiftActiv B3 in Post Inflammatory Hyperpigmentation (PIHP)

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