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

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.

Study Overview

• Status: Completed
• Conditions: Post Inflammatory Hyperpigmentation
• Intervention / Treatment: Other: Pigment Balancing Peel; Other: Discoloration Defense Serum; Other: LHA Cleansing Gel; Other: Hydrating B5 Gel; Other: Daily Brightening Sunscreen

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11209
      • New York Harbor VA Brooklyn Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Pigment Balancing Peel; Chemical Peel; Other: Discoloration Defense Serum; Dark spot correcting serum; Other: LHA Cleansing Gel; exfoliating gel facial cleanser; Other: Hydrating B5 Gel; Vitamin B5 serum with hyaluronic acid; Other: Daily Brightening Sunscreen; daily moisturizing sunscreen SPF 30

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in DLQI at baseline vs week 12	Change in the DLQI (ranges from 0 (no impact on quality of life) to 30 (maximum impairment)) following use of Pigment Balancing Peel, Hydrating B5 Gel, Discoloration Defense, LHA Cleanser Gel and Brightening Sunscreen, 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	Change in the melanin (0-999) and erythema (0-999) index measured by the Delfin SkinColorCatch at baseline, week 6 and week 12. (0 is lightest and 100 is darkest)	From enrollment to end of treatment at 12 weeks
Patient expectations utilizing FACE-Q Expectations Scale	To assess patient expectations regarding the impact of treatment on their lives utilizing FACE-Q Expectations Scale (scores range from 0 (lowest) to 100 (highest)), as completed by the patient at baseline visit.	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	To evaluate changes in psychosocial factors following aesthetic treatment, utilizing FACE-Q Social Function Scale (scores range from 0 (lowest) to 100 (highest)) as completed by the patient 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	To evaluate changes in psychosocial factors following aesthetic treatment, utilizing FACE-Q Psychological Function Scale (scores range from 0 (lowest) to 100 (highest)) as completed by the patient at baseline vs week 12.	From enrollment to end of treatment at 12 weeks
Patient satisfaction with treatment using FACE-Q outcome scale at week 12	To assess patient satisfaction with treatment using the FACE-Q Outcome Satisfaction Scale, (scores range from 0 (lowest) to 100 (highest)) as completed by the patient at week 12	From enrollment to end of treatment at 12 weeks

Collaborators and Investigators

• Sponsor: Narrows Institute for Biomedical Research
• Collaborators: L'Oreal
• Investigators: Principal Investigator: Jared Jagdeo, MD MS, SUNY Downstate Health Sciences University Department of Dermatology

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2025
• Primary Completion (Actual): July 1, 2025
• Study Completion (Actual): July 20, 2025

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: skin of color; post inflammatory hyperpigmentation; skinceuticals
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Skin and Connective Tissue Diseases; Hyperpigmentation; Physiological Effects of Drugs; Dermatologic Agents; Protective Agents; Radiation-Protective Agents; Sunscreening Agents
• Other Study ID Numbers: 1792718

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No