Study on the Functional Impact of Cosmetics on Improving Self-Esteem and Quality of Life in Black Women

Study on the Functional Impact of Cosmetics on Improving Self-Esteem and Quality of Life in Black Women

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.

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)