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

Narrows Institute for Biomedical Research

Status: Active, not recruiting

Conditions: Post Inflammatory Hyperpigmentation

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06938815

1792718

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Pigment Balancing Peel and Post Peel Regimen

Experimental group

Description:

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.

Treatment:

Other: LHA Cleansing Gel

Other: Discoloration Defense Serum

Other: Daily Brightening Sunscreen

Other: Hydrating B5 Gel

Other: Pigment Balancing Peel