Post Inflammatory HyperpigmentationNCT06938815
A Novel Regimen for Treatment and Prevention of Post-Inflammatory Hyperpigmentation in Skin of Color
A study testing Pigment Balancing Peel, Discoloration Defense Serum and LHA Cleansing Gel in people with Post Inflammatory Hyperpigmentation, run by Narrows Institute for Biomedical Research at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Inflammatory Hyperpigmentation
- What is being tested?
- Pigment Balancing Peel, Discoloration Defense Serum and LHA Cleansing Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2025to 20 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Harbor VA Brooklyn Campus
Brooklyn, New York, 11209
About this study
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.
- Conditions
- Post Inflammatory Hyperpigmentation
- Being tested
- Pigment Balancing Peel, Discoloration Defense Serum, LHA Cleansing Gel, Hydrating B5 Gel, Daily Brightening Sunscreen
- Keywords
- skin of color, post inflammatory hyperpigmentation, skinceuticals
- Medical subject headings
- Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pigment Balancing PeelOther
Chemical Peel
Discoloration Defense SerumOther
Dark spot correcting serum
LHA Cleansing GelOther
exfoliating gel facial cleanser
Hydrating B5 GelOther
Vitamin B5 serum with hyaluronic acid
Daily Brightening SunscreenOther
daily moisturizing sunscreen SPF 30
| Study group | Role | What they receive |
|---|---|---|
| Pigment Balancing Peel and Post Peel Regimen | Experimental | 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. Receives: Other: Pigment Balancing Peel; Other: Discoloration Defense Serum; Other: LHA Cleansing Gel; Other: Hydrating B5 Gel; Other: Daily Brightening Sunscreen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to end of treatment at 12 weeks
Secondary outcomes (6)
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.
Measured: From enrollment to end of treatment at 12 weeks
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)
Measured: From enrollment to end of treatment at 12 weeks
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.
Measured: 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
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.
Measured: 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
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.
Measured: From enrollment to end of treatment at 12 weeks
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
Measured: From enrollment to end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start28 Feb 2025
- Primary completion1 Jul 2025
- Study completion20 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Inflammatory HyperpigmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Narrows Institute for Biomedical Research
- Sponsor type
- University, hospital or other
- Collaborators
- L'Oreal
- Responsible party
- Sponsor
- Investigators
- Jared Jagdeo, MD MS, Principal investigator, SUNY Downstate Health Sciences University Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938815
- Sponsor's protocol ID
- 1792718
- Status last verified
- Feb 2025
- First submitted
- 2 Apr 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Regimen for Treatment and Prevention of Post-Inflammatory Hyperpigmentation in Skin of Color
- ClinicalTrials.gov ID
- NCT06938815
- Acronym / sponsor ID
- 1792718
- Conditions
- Post Inflammatory Hyperpigmentation
- Keywords
- skin of color, post inflammatory hyperpigmentation, skinceuticals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Narrows Institute for Biomedical ResearchUniversity, hospital or other
- Collaborators
- L'Oreal
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pigment Balancing Peel and Post Peel Regimen | Experimental | Other: Pigment Balancing Peel, Other: Discoloration Defense Serum, Other: LHA Cleansing Gel, Other: Hydrating B5 Gel, Other: Daily Brightening SunscreenDiscoloration 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pigment Balancing PeelChemical Peel | Other | Pigment Balancing Peel and Post Peel Regimen |
| Discoloration Defense SerumDark spot correcting serum | Other | Pigment Balancing Peel and Post Peel Regimen |
| LHA Cleansing Gelexfoliating gel facial cleanser | Other | Pigment Balancing Peel and Post Peel Regimen |
| Hydrating B5 GelVitamin B5 serum with hyaluronic acid | Other | Pigment Balancing Peel and Post Peel Regimen |
| Daily Brightening Sunscreendaily moisturizing sunscreen SPF 30 | Other | Pigment Balancing Peel and Post Peel Regimen |
Primary outcome
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.
6 secondary outcomes
Change in DLQI at baseline vs week 12
Time frame: 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
Patient expectations utilizing FACE-Q Expectations Scale
Time frame: 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
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
Patient satisfaction with treatment using FACE-Q outcome scale at week 12
Time frame: From enrollment to end of treatment at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Post Inflammatory Hyperpigmentation
Not yet recruiting
Evaluating a Brightening Serum for Post-Inflammatory Hyperpigmentation
Post-inflammatory Hyperpigmentation, Post-acne Hyperpigmentation
Recruiting
A Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Participants
Post-inflammatory Hyperpigmentation, Melasma
Recruiting
Study on the Functional Impact of Cosmetics on Improving Self-Esteem and Quality of Life in Black Women
Post-inflammatory Hyperpigmentation
Not yet recruiting
Evaluation of Efficacy and Tolerabilty of MelaB3 Serum in Combination of 35% Glycolic Acid Peeling Compared to 35% Glycolic Acid Peeling Alone in Various Hyperpigmentation Conditions
Hyperpigmentation, Melasma
Recruiting
Fractionated 1927-nm Non Ablative Thulium Laser in Treating Post Inflammatory Hyperpigmentation
Healthy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jared Jagdeo, MD MS principal investigator
SUNY Downstate Health Sciences University Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pigment Balancing Peel, Discoloration Defense Serum and LHA Cleansing Gel in people with Post Inflammatory Hyperpigmentation, run by Narrows Institute for Biomedical Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.