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Completed

NCT Number: NCT06938815

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.

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Key information

Conditions

Post Inflammatory Hyperpigmentation Hyperpigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Harbor VA Brooklyn Campus

Brooklyn, New York, 11209, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pigment Balancing Peel

Other

Chemical Peel

Discoloration Defense Serum

Other

Dark spot correcting serum

LHA Cleansing Gel

Other

exfoliating gel facial cleanser

Hydrating B5 Gel

Other

Vitamin B5 serum with hyaluronic acid

Daily Brightening Sunscreen

Other

daily moisturizing sunscreen SPF 30

Primary outcomes

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

    Time frame: From enrollment to end of treatment at 12 weeks

    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.

Secondary outcomes

  1. Change in DLQI at baseline vs week 12

    Time frame: From enrollment to end of treatment at 12 weeks

    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.

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

    Time frame: From enrollment to end of treatment at 12 weeks

    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)

  3. Patient expectations utilizing FACE-Q Expectations Scale

    Time frame: From enrollment to end of treatment at 12 weeks

    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.

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

    Time frame: From enrollment to end of treatment at 12 weeks

    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.

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

    Time frame: From enrollment to end of treatment at 12 weeks

    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.

  6. Patient satisfaction with treatment using FACE-Q outcome scale at week 12

    Time frame: From enrollment to end of treatment at 12 weeks

    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

Sponsors and collaborators

Lead sponsor

Narrows Institute for Biomedical Research

Other

Collaborators

  • L'Oreal

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 22, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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