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

November 21, 2025 updated by: Narrows Institute for Biomedical Research
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11209
        • New York Harbor VA Brooklyn Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Chemical Peel
Other: Discoloration Defense Serum
Dark spot correcting serum
Other: LHA Cleansing Gel
exfoliating gel facial cleanser
Other: Hydrating B5 Gel
Vitamin B5 serum with hyaluronic acid
Other: Daily Brightening Sunscreen
daily moisturizing sunscreen SPF 30

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From enrollment to end of treatment at 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
From enrollment to end of treatment at 12 weeks
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)
From enrollment to end of treatment at 12 weeks
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.
From enrollment to end of treatment at 12 weeks
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.
From enrollment to end of treatment at 12 weeks
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.
From enrollment to end of treatment at 12 weeks
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
From enrollment to end of treatment at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Narrows Institute for Biomedical Research

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
L'Oreal

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jared Jagdeo, MD MS, SUNY Downstate Health Sciences University Department of Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1792718

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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