Skincare Regimen for Postinflammatory Hyperpigmentation

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Narrows Institute for Biomedical Research

Disqualifiers: Caucasian, Pregnant, Investigational study, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

10 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using any skin treatments that might interfere with the study, you may need to stop those.

What data supports the effectiveness of the skincare regimen for postinflammatory hyperpigmentation?

Research shows that combining chemical peels with topical treatments, like those in the regimen, can effectively reduce facial hyperpigmentation. Studies found significant improvements in skin tone and discoloration when using similar treatments, with patients reporting high satisfaction. ^{1 2 3 4 5}

Is the skincare regimen for postinflammatory hyperpigmentation safe for humans?

The skincare regimen, which includes treatments like chemical peels and topical agents, is generally considered safe, but some patients may experience adverse effects such as irritation or worsening of hyperpigmentation. It's important to follow precautionary measures and use photoprotection to minimize risks. ^{1 5 6 7 8}

How does the Pigment Balancing Peel treatment differ from other treatments for postinflammatory hyperpigmentation?

The Pigment Balancing Peel treatment is unique because it combines a series of very superficial chemical peels with a comprehensive pigmentation control serum, which is applied twice daily. This combination approach is designed to be effective for skin of color, providing significant improvements in hyperpigmentation without causing additional skin damage, unlike some other treatments that may risk worsening the condition. ^{1 2 3 8 9}

Research Team

Jared Jagdeo, MD MS

Principal Investigator

SUNY Downstate Health Sciences University Department of Dermatology

Eligibility Criteria

This trial is for non-Caucasian men and women over 18 with skin types IV-VI who have post-inflammatory hyperpigmentation. Participants must be willing to follow the study's instructions and attend all visits, not be pregnant or lactating, nor participating in other clinical studies.

Inclusion Criteria

Fitzpatrick skin types IV-VI

Able and willing to provide written and verbal informed consent

Non-Caucasian

Exclusion Criteria

Study participant has facial hair that could interfere with the study assessments in the opinion of the investigator

I don't have skin conditions that could affect test results or need treatment that could interfere.

Caucasian/ Non-Hispanic

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive the SkinCeuticals comprehensive skin care regimen, including the Pigment Balancing Peel and a regimen of Hydrating B5 Gel, Discoloration Defense, LHA Cleansing Gel, and Brightening UV Defense sunscreen

12 weeks

Regular visits for treatment application and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Daily Brightening Sunscreen
• Discoloration Defense Serum
• Hydrating B5 Gel
• LHA Cleansing Gel
• Pigment Balancing Peel

Trial Overview The trial tests a SkinCeuticals regimen including Pigment Balancing Peel and supplementary products (Discoloration Defense Serum, LHA Cleansing Gel, Hydrating B5 Gel, Daily Brightening Sunscreen) over 12 weeks to reduce hyperpigmentation in skin of color.

Participant Groups

Group I: Pigment Balancing Peel and Post Peel Regimen Experimental Treatment 5 Interventions

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.

Who Is Running the Clinical Trial?

Narrows Institute for Biomedical Research

Lead Sponsor

Trials

5

Recruited

650+

L'Oreal

Industry Sponsor

Trials

22

Recruited

11,100+

References

1. United States pubmed.ncbi.nlm.nih.gov

Synergistic Combination of an In-office Procedure and Home Regimen for the Treatment of Facial Hyperpigmentation. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Assessment of a superficial chemical peel combined with a multimodal, hydroquinone-free skin brightener using in vivo reflectance confocal microscopy. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Combination of In-Office Chemical Peels With a Topical Comprehensive Pigmentation Control Product in Skin of Color Subjects With Facial Hyperpigmentation. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Hydroquinone-free multimodal topical regimen for facial hyperpigmentation. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

A Topical Depigmentation Program Against Hyperpigmentation Enhances the Benefits of Previously Performed Chemical Peeling Procedures of the Face. [2021]

6. France pubmed.ncbi.nlm.nih.gov

[Post-inflammatory hyperpigmentation occuring after cosmetic procedures]. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Post-inflammatory hyperpigmentation: A systematic review of treatment outcomes. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Postinflammatory hyperpigmentation: a review of the epidemiology, clinical features, and treatment options in skin of color. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Postinflammatory hyperpigmentation: evolving combination treatment strategies. [2016]