ClinicalTrials.gg
CompletedNCT06938815Updated Nov 24, 2025

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

An interventional study of Pigment Balancing Peel and Discoloration Defense Serum in Post Inflammatory Hyperpigmentation, sponsored by Narrows Institute for Biomedical Research. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-24.

Sponsored by Narrows Institute for Biomedical Research · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Post Inflammatory Hyperpigmentation

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Keywords

  • skin of color
  • post inflammatory hyperpigmentation
  • skinceuticals
03

In context

Hyperpigmentation

127 studies on the registry are indexed under Hyperpigmentation; 28 are open to participants now.

This study's enrollment of 10 is below the median of 32 across 113 interventional studies indexed under Hyperpigmentation.

Browse Hyperpigmentation studies →

Lead sponsor

Narrows Institute for Biomedical Research is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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 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 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • 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 · Other: Discoloration Defense Serum · Other: LHA Cleansing Gel · Other: Hydrating B5 Gel · Other: Daily Brightening Sunscreen

Interventions

  • OtherPigment Balancing Peel

    Chemical Peel

  • OtherDiscoloration Defense Serum

    Dark spot correcting serum

  • OtherLHA Cleansing Gel

    exfoliating gel facial cleanser

  • OtherHydrating B5 Gel

    Vitamin B5 serum with hyaluronic acid

  • OtherDaily Brightening Sunscreen

    daily moisturizing sunscreen SPF 30

06

What researchers measure

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. 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.

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

  2. 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)

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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

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

07

Study locations

1 site
  • New York Harbor VA Brooklyn Campus
    Brooklyn, New York 11209, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2025 to primary completion in Jul 2025, 4 months.

Of 37 non-industry interventional studies with no phase under Hyperpigmentation, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's 4 months is below that.

Counting every sponsor, half of 64 studies reached it within 7 months; a quarter within 3 and three quarters within 25.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 2, 2025
First posted
Apr 22, 2025
StartActual
Feb 28, 2025
Primary completionActual
Jul 1, 2025
CompletionActual
Jul 20, 2025
Last update
Nov 24, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06938815
Lead sponsor
Narrows Institute for Biomedical Research
Collaborators
L'Oreal
Responsible party
Sponsor
First posted
Apr 22, 2025
Start date
Feb 28, 2025
Primary completion
Jul 1, 2025
Completion
Jul 20, 2025
Last update
Nov 24, 2025

Study contacts

Jared Jagdeo, MD MS
principal investigator · SUNY Downstate Health Sciences University Department of Dermatology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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