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

Overview

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.

Interventions

• Drug Niacinamide and Bioceramide-Based Skincare Regimen
  A standardized facial skincare regimen containing a cleanser (0.2% Bioceramides), moisturizer (2% Niacinamide + 1% Bioceramides), serum (5% Niacinamide + 3% Bioceramides), and SPF 30 sunscreen. The products are intended for daily use, with cleanser applied twice daily, moisturizer applied in the morning, serum applied at night, and sunscreen applied twice daily.

Primary outcome measures

• Change in Hyperpigmentation Severity Assessed by Hyperpigmentation Area Severity Scale (HASI) [Time frame: Baseline, Week 6, and Week 12]
• Visual Assessment of Post-Inflammatory Hyperpigmentation Using Standardized Facial Photography [Time frame: Baseline, Week 6, and Week 12]
• Change in Hyperpigmentation Severity Assessed by Investigator's Global Assessment (IGA) [Time frame: Baseline, Week 6, and Week 12]

Secondary outcome measures (2)

• Change in Quality of Life Assessed by Melasma Quality of Life Scale (MelasQoL) [Time frame: Baseline, Week 6, and Week 12]
• Change in Quality of Life Assessed by Dermatology Life Quality Index (DLQI) [Time frame: 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Brazil · 1 center

• Hospital Israelita Albert Einstein — São Paulo

Identifiers

NCT: NCT07618572 · COTY_10772

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗