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| Name | Class |
|---|---|
| L'Oreal | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pigment Balancing Peel | Other | Chemical Peel |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to end of treatment at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to end of treatment at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jared Jagdeo, MD MS | SUNY Downstate Health Sciences University Department of Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Harbor VA Brooklyn Campus | Brooklyn | New York | 11209 | United States |
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| 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 |
|
| 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) |
| 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. | 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. | 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. | 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 | From enrollment to end of treatment at 12 weeks |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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