💬In plain words
What the trial is, and whether it could suit you
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 photogr
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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)
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