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NCT07618572
Study on the Functional Impact of Cosmetics on Improving Self-Esteem and Quality of Life in Black Women
Conditions: Post-inflammatory Hyperpigmentation
Sex: Female
Ages: 18 Years – 55 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Hospital Israelita Albert Einstein
Location: Hospital Israelita Albert Einstein São Paulo São Paulo
Summary
The goal of this clinical trial is to evaluate whether the use of dermocosmetics containing Bioceramides and Niacinamide can improve post-inflammatory hyperpigmentation and promote positive impacts on self-esteem and quality of life in Brazilian Black women with facial hyperpigmentation (Fitzpatrick skin types IV to VI).
The main questions it aims to answer are:
* Does the treatment improve hyperpigmentation severity as measured by HASI and IGA scores?
* Does the treatment improve participants' self-esteem and quality of life as assessed by MELASQoL and DLQI questionnaires?
Participants will:
* Use a standardized skincare routine including cleanser (0.2% Bioceramides), moisturizer (2% Niacinamide + 1% Bioceramides), serum (5% Niacinamide + 3% Bioceramides), and SPF 30 sunscreen for 12 weeks.
* Attend study visits at baseline, week 6, and week 12.
* Undergo standardized facial photography and clinical assessments by specialists at baseline, week 6, and week 12.
* Complete questionnaires related to self-esteem and quality of life at baseline, week 6, and week 12.
Eligibility 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)
Source: ClinicalTrials.gov (NCT07618572). StuddyBuddy aggregates publicly available trial information.