Clinical trial NCT06938815: A Novel Regimen for Treatment and Prevention of Post-Inflammatory Hyperpigmentation in Skin of Color
Official title: A Novel Regimen for Treatment and Prevention of Post-Inflammatory Hyperpigmentation in Skin of Color
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Post Inflammatory Hyperpigmentation
Keywords: skin of color
post inflammatory hyperpigmentation
skinceuticals
Lead sponsor: Narrows Institute for Biomedical Research
Sponsor class: OTHER
Collaborators: name: L'Oreal
First posted: 2025-04-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline to week 12 of patient satisfaction in improvement of post-inflammatory hyperpigmentation
timeFrame: From enrollment to end of treatment at 12 weeks
Secondary outcomes:
measure: Change in DLQI at baseline vs week 12
timeFrame: From enrollment to end of treatment at 12 weeks
measure: Change in the melanin and erythema index at baseline, week 6, and week 12
timeFrame: From enrollment to end of treatment at 12 weeks
measure: Patient expectations utilizing FACE-Q Expectations Scale
timeFrame: From enrollment to end of treatment at 12 weeks
measure: Change in psychosocial factors utilizing the FACE-Q Social Function Scale following treatment at baseline vs week 12
timeFrame: From enrollment to end of treatment at 12 weeks
measure: Change in psychosocial factors utilizing the FACE-Q Psychological Function Scale following treatment at baseline vs week 12
timeFrame: From enrollment to end of treatment at 12 weeks
measure: Patient satisfaction with treatment using FACE-Q outcome scale at week 12
timeFrame: From enrollment to end of treatment at 12 weeks
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: New York Harbor VA Brooklyn Campus
state: New York
Study officials:
affiliation: SUNY Downstate Health Sciences University Department of Dermatology
name: Jared Jagdeo, MD MS
role: PRINCIPAL_INVESTIGATOR
References: