LiftActiv B3 in Post Inflammatory Hyperpigmentation (PIHP)

NCT05327361 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 20211099
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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)

Conditions

Acne; Post Inflammatory Hyperpigmentation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in the Investigators Global Assessment (IGA) Scale

  Baseline, 1 month, 2 months and 3 months

• Change in Skin Condition Evaluation Scores

  Baseline, 1 month, 2 months and 3 months

• Change in Global Efficacy Assessment

  1 month, 2 months, and 3 months

• Change in Global Tolerance Score

  1 month, 2 months, and 3 months

• Change in Cosmeticity Questionnaire and Acceptability

  1 month, 2 months, and 3 months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Other: Sunscreen

Liftactiv B3

EXPERIMENTAL

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

Interventions

Liftactiv B3 DRUG

Participants will apply a dime size amount of the serum to 1 side of the face.

Liftactiv B3

Sunscreen OTHER

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

Control Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Multiethnic subjects
• to 50 YO
• Phototype III-VI
• All skin types
• % 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• Vichy Laboratoires: collaborator

Study Sites (1)

University of Miami Hospital

Miami, Florida, 33125, United States

Location

MeSH Terms

Conditions

Acne Vulgaris; Hyperpigmentation

Interventions

Sunscreening Agents

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Pigmentation Disorders

Intervention Hierarchy (Ancestors)

Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Dermatologic Agents; Therapeutic Uses; Cosmetics; Specialty Uses of Chemicals

Results Point of Contact

• Title: Enzo Berardesca
• Organization: University of Miami

exb743@med.miami.edu

3052434472

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: April 14, 2022
• Study Start: March 22, 2022
• Primary Completion: January 17, 2023
• Study Completion: March 6, 2023
• Last Updated: April 3, 2024
• Results First Posted: April 3, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)