Post Inflammatory Hyperpigmentation
Conditions
Keywords
skin of color, post inflammatory hyperpigmentation, skinceuticals
Brief 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.
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
Sponsors
L'Oreal
Narrows Institute for Biomedical Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to week 12 of patient satisfaction in improvement of post-inflammatory hyperpigmentation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the melanin and erythema index at baseline, week 6, and week 12 | 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) |
| Patient expectations utilizing FACE-Q Expectations Scale | 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. |
| Change in DLQI at baseline vs week 12 | 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. |
| Change in psychosocial factors utilizing the FACE-Q Psychological Function Scale following treatment at baseline vs week 12 | 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. |
| Patient satisfaction with treatment using FACE-Q outcome scale at week 12 | 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 |
| Change in psychosocial factors utilizing the FACE-Q Social Function Scale following treatment at baseline vs week 12 | 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. |
Countries
United States
Outcome results
None listed