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

NCT07618572 | Recruiting

• 1 other identifier: COTY_10772
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-inflammatory Hyperpigmentation

Keywords

Post-inflammatory Hyperpigmentation; Bioceramides; Niacinamide; Black Women; Facial Hyperpigmentation

Outcome Measures

Primary Outcomes (3)

• Change in Hyperpigmentation Severity Assessed by Hyperpigmentation Area Severity Scale (HASI)

  The Hyperpigmentation Area Severity Scale (HASI), adapted from the Melasma Area Severity Index (MASI), will be used to evaluate pigmentation severity. The face will be divided into four regions (forehead, right malar, left malar, and chin). Hyperpigmentation severity will be assessed based on three components: pigmentation intensity and homogeneity (both scored from 0 to 4), and the affected area (scored from 0 to 6). A weighted sum will be calculated for each region using the following formula: HASI = 0.3 × (area score) × (intensity + homogeneity) for the forehead and malar regions, and 0.1 × (area score) × (intensity + homogeneity) for the chin. The total HASI score will be obtained by summing all regions, ranging from 0 to 48, with higher scores indicating greater hyperpigmentation severity.

  Baseline, Week 6, and Week 12

• Visual Assessment of Post-Inflammatory Hyperpigmentation Using Standardized Facial Photography

  Standardized facial photographs will be obtained at each study visit and will be evaluated by a dermatologist to assess post-inflammatory hyperpigmentation. Images will be captured under visible light using a standardized protocol (Rossi et al., 2011), including three facial views (frontal, left 45°, and right 45°). The face will be divided into seven regions for visual analysis and quantification of pigmented areas using ImageJ software (version 1.45p, NIH). All photographs will be acquired using consistent camera settings, lighting conditions, and participant positioning throughout the study to ensure comparability.

  Baseline, Week 6, and Week 12

• Change in Hyperpigmentation Severity Assessed by Investigator's Global Assessment (IGA)

  The Investigator's Global Assessment (IGA) is a visual assessment that will be used to provide an overall evaluation of post-inflammatory hyperpigmentation severity. Assessments will be performed by a dermatologist using a 6-point scale ranging from 0 to 5, according to morphological characteristics of pigmentation: 0 = no hyperpigmentation; 1 = almost clear; 2 = mild but noticeable hyperpigmentation; 3 = moderate hyperpigmentation (medium brown); 4 = severe hyperpigmentation (dark brown); and 5 = very severe hyperpigmentation (very dark brown to nearly black). Higher scores will indicate greater severity of pigmentation.

  Baseline, Week 6, and Week 12

Secondary Outcomes (2)

• Change in Quality of Life Assessed by Melasma Quality of Life Scale (MelasQoL)

  Baseline, Week 6, and Week 12

• Change in Quality of Life Assessed by Dermatology Life Quality Index (DLQI)

  Baseline, Week 6, and Week 12

Study Arms (1)

Intervention

EXPERIMENTAL

Participants will receive a standardized facial skincare regimen to be used daily for 12 weeks, including a cleanser (0.2% Bioceramides), moisturizer (2% Niacinamide + 1% Bioceramides), serum (5% Niacinamide + 3% Bioceramides), and SPF 30 sunscreen (non-investigational). Products will be used daily, with cleanser twice daily, moisturizer in the morning, serum at night, and sunscreen twice daily. Participants will undergo evaluations at baseline, week 6, and week 12, including standardized photography and assessment using Hyperpigmentation Area Severity Scale (HASI) and Investigator's Global Assessment (IGA). Quality of life will be assessed with Melasma Quality of Life Scale (MelasQoL) and Dermatology Life Quality Index (DLQI). Participants will complete daily diaries to record product use and any reactions during the study, and will assess perceived product efficacy at the final visit.

Drug: Niacinamide and Bioceramide-Based Skincare Regimen

Interventions

Niacinamide and Bioceramide-Based Skincare Regimen DRUG

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• COTY BRASIL COMERCIO S.A.: collaborator

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05652-900, Brazil

RECRUITING

MeSH Terms

Conditions

Hyperpigmentation

Interventions

Niacinamide

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Bruna Cestari de Azevedo, PhD

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Andrade-Silva, PhD

CONTACT

+55975295921; jessica.as@einstein.br

Camila Hernandes Pinheiro, PhD

CONTACT

+5511952960024; camila.hernandes@einstein.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 1, 2026
• Study Start: March 19, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

BR (1)