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

NCT06938815 | Completed

• 1 other identifier: 1792718
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Inflammatory Hyperpigmentation

Keywords

skin of color; post inflammatory hyperpigmentation; skinceuticals

Outcome Measures

Primary Outcomes (1)

• Change from baseline to week 12 of patient satisfaction in improvement of post-inflammatory hyperpigmentation

  Change in the patient satisfaction with their physical appearance following use of SkinCeuticals regimen to improve post inflammatory hyperpigmentation, using the FACE-Q Satisfaction (scores range from 0 (lowest) to 100 (highest)), at week 12 compared to baseline.

  From enrollment to end of treatment at 12 weeks

Secondary Outcomes (6)

• Change in DLQI at baseline vs week 12

  From enrollment to end of treatment at 12 weeks

• Change in the melanin and erythema index at baseline, week 6, and week 12

  From enrollment to end of treatment at 12 weeks

• Patient expectations utilizing FACE-Q Expectations Scale

  From enrollment to end of treatment at 12 weeks

• Change in psychosocial factors utilizing the FACE-Q Social Function Scale following treatment at baseline vs week 12

  From enrollment to end of treatment at 12 weeks

• Change in psychosocial factors utilizing the FACE-Q Psychological Function Scale following treatment at baseline vs week 12

  From enrollment to end of treatment at 12 weeks

Study Arms (1)

Pigment Balancing Peel and Post Peel Regimen

EXPERIMENTAL

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.

Other: Pigment Balancing Peel; Other: Discoloration Defense Serum; Other: LHA Cleansing Gel; Other: Hydrating B5 Gel; Other: Daily Brightening Sunscreen

Interventions

Pigment Balancing Peel OTHER

Chemical Peel

Pigment Balancing Peel and Post Peel Regimen

Discoloration Defense Serum OTHER

Dark spot correcting serum

Pigment Balancing Peel and Post Peel Regimen

LHA Cleansing Gel OTHER

exfoliating gel facial cleanser

Pigment Balancing Peel and Post Peel Regimen

Hydrating B5 Gel OTHER

Vitamin B5 serum with hyaluronic acid

Pigment Balancing Peel and Post Peel Regimen

Daily Brightening Sunscreen OTHER

daily moisturizing sunscreen SPF 30

Pigment Balancing Peel and Post Peel Regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Narrows Institute for Biomedical Research: lead
• L'Oreal: collaborator

Study Sites (1)

New York Harbor VA Brooklyn Campus

Brooklyn, New York, 11209, United States

Location

MeSH Terms

Conditions

Hyperpigmentation

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jared Jagdeo, MD MS

  SUNY Downstate Health Sciences University Department of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 22, 2025
• Study Start: February 28, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 20, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-02

Locations

US (1)