A Novel Regimen for Treatment and Prevention of Post-Inflammatory Hyperpigmentation in Skin of Color

NCT ID: NCT06938815

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-28

Study Completion Date

2025-07-20

Brief Summary

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This is a single-center, prospective, non-blinded, non-randomized 12 week clinical study to evaluate the efficacy of a SkinCeuticals comprehensive skin care regimen in the reduction of post inflammatory hyperpigmentation (PIH) in skin of color patients. The comprehensive regimen features the Pigment Balancing Peel which combines glycolic acid, lactic acid, kojic acid, vitamin C, and emblica into a treatment that may improve skin discoloration. Participants will supplement the Pigment Balancing Peel with a 11 week regimen that includes the Hydrating B5 Gel, Discoloration Defense, LHA Cleansing Gel, and Brightening UV Defense sunscreen.

Detailed Description

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Conditions

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Post Inflammatory Hyperpigmentation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pigment Balancing Peel and Post Peel Regimen

Discoloration Defense Serum: Applied twice daily (morning and night) LHA Cleansing Gel: Used twice daily (AM and PM) to cleanse the skin and target discoloration.

Hydrating B5 Gel: Applied throughout the day to hydrate the skin. Brightening UV Defense Sunscreen: Used throughout the day.

Group Type EXPERIMENTAL

Pigment Balancing Peel

Intervention Type OTHER

Chemical Peel

Discoloration Defense Serum

Intervention Type OTHER

Dark spot correcting serum

LHA Cleansing Gel

Intervention Type OTHER

exfoliating gel facial cleanser

Hydrating B5 Gel

Intervention Type OTHER

Vitamin B5 serum with hyaluronic acid

Daily Brightening Sunscreen

Intervention Type OTHER

daily moisturizing sunscreen SPF 30

Interventions

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Pigment Balancing Peel

Chemical Peel

Intervention Type OTHER

Discoloration Defense Serum

Dark spot correcting serum

Intervention Type OTHER

LHA Cleansing Gel

exfoliating gel facial cleanser

Intervention Type OTHER

Hydrating B5 Gel

Vitamin B5 serum with hyaluronic acid

Intervention Type OTHER

Daily Brightening Sunscreen

daily moisturizing sunscreen SPF 30

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Men and women ages 18+.
* Clinical diagnosis of Post Inflammatory Hyperpigmentation
* Non-Caucasian
* Fitzpatrick skin types IV-VI
* Available and willing to comply with study instructions and attend all study visits.
* Able and willing to provide written and verbal informed consent.

Exclusion Criteria

* Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy.
* Caucasian/ Non-Hispanic
* Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
* Pregnant, lactating, or is planning to become pregnant during the study.
* Subject is currently enrolled in an investigational drug or device study.
* Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (baseline).
* Study participant has facial hair that could interfere with the study assessments in the opinion of the investigator.
* Study participant is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
* Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles.
* Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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L'Oreal

INDUSTRY

Sponsor Role collaborator

Narrows Institute for Biomedical Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jared Jagdeo, MD MS

Role: PRINCIPAL_INVESTIGATOR

SUNY Downstate Health Sciences University Department of Dermatology

Locations

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New York Harbor VA Brooklyn Campus

Brooklyn, New York, United States

Site Status

Countries

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United States

Other Identifiers

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1792718

Identifier Type: -

Identifier Source: org_study_id

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