Cosmetics to Improve Self-Esteem and Quality of Life for Black Women with Facial Hyperpigmentation
Official title: Study on the Functional Impact of Cosmetics on Improving Self-Esteem and Quality of Life in Black Women
Run by Hospital Israelita Albert Einstein · NCT07618572 · Data updated 2026-11-12
This study tests a skincare routine containing bioceramides and niacinamide to see if it can lessen facial PIH and boost self-esteem and quality of life in Black Brazilian women.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 55 Years |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | Hospital Israelita Albert Einstein Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Status | Recruiting |
| Started | March 19, 2026 |
| Main results expected | October 31, 2026 |
| Study ends | October 31, 2026 |
| Registry record updated | June 4, 2026 |
| Trial ID | NCT07618572 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–55 with clinical facial PIH, self-identifying as Black (including preta or parda), Fitzpatrick IV–VI, affiliated with the hosting hospital, and able to consent and attend all visits.
✕Probably not a fit
Participants who do not experience pigmentation improvement or who have adverse reactions to the cosmetic regimen may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study evaluates a dermocosmetic regimen with bioceramides and niacinamide for treating facial post-inflammatory hyperpigmentation in Black women with Fitzpatrick skin types IV–VI. Participants follow a 12-week standardized skincare routine and attend visits at baseline, week 6, and week 12, with standardized facial photography and clinical assessments. Outcomes include changes in pigmentation severity using HASI and IGA scores, and patient-reported quality of life and self-esteem via MELASQoL and DLQI. The study is conducted at Hospital Israelita Albert Einstein in São Paulo, with collaboration from COTY Brasil. Eligible participants are adult women who meet the PIH and skin type criteria and are affiliated with the institution; several safety-related exclusions apply.
Why it matters
Potential benefit: If successful, participants may see reduced facial hyperpigmentation and improved self-esteem and daily quality of life.
How similar studies have gone: Prior studies in cosmetic dermatology have shown improvements in hyperpigmentation and patient-reported outcomes with niacinamide-containing regimens, supporting exploration in this population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female participants aged 18 to 55 years * Clinical diagnosis of facial post-inflammatory hyperpigmentation (PIH) * Self-identified as Black (including "preta" or "parda") * Fitzpatrick skin types IV to VI * Employees, students, or affiliated personnel of Hospital Israelita Albert Einstein (including contractors and fellows), recruited from institution units * Willing and able to comply with all study procedures and attend all scheduled visits * Able and willing to provide written informed consent and authorization for image use Exclusion Criteria: * Pregnant or breastfeeding women, or those planning pregnancy during the study period * Type 1 diabetes mellitus or related complications (e.g., nephropathy, dermatological conditions associated with diabetes, history of hypoglycemia, diabetic ketoacidosis, or hyperosmolar coma) * Known or suspected intolerance to similar cosmetic products * History of atopy or allergic reactions to cosmetic products * Personal or family history of skin cancer * Active skin conditions or lesions affecting the face * Facial marks or scars that may interfere with assessments * Skin irritation due to recent sun exposure * Excessive sun or UV exposure, including artificial tanning, within the past month * Use of facial cosmetic products within 7 days before screening * Use of topical or systemic treatments within 1 month before screening * Use of depigmentation treatments within 3 months before screening * Use of dermocosmetic treatments for PIH within 3 months before screening * Facial dermatological or aesthetic procedures within 2 weeks before screening * Use of corticosteroids, anticoagulants, or immunosuppressive drugs * Score ≥5 indicating anxiety or depression on Patient Health Questionnaire (PHQ-9) or Generalized Anxiety Disorder scale (GAD-7) * Any other condition that, in the investigator's judgment, may compromise study participation or results (to be documented in the medical record)
Where it's running
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Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil Recruiting
Study contacts
- Principal investigator: Bruna Cestari de Azevedo, PhD — Hospital Israelita Albert Einstein
- Study coordinator: Jessica Andrade-Silva, PhD
- Email: jessica.as@einstein.br
- Phone: +55975295921
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.