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

Narrows Institute for Biomedical Research10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Post Inflammatory Hyperpigmentation

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.