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

NCT07618572 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-06-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • COTY BRASIL COMERCIO S.A.

    collaborator UNKNOWN

  • Hospital Israelita Albert Einstein

    lead OTHER

Principal Investigators

  • Bruna Cestari de Azevedo, PhD · Hospital Israelita Albert Einstein

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-19
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07618572 on ClinicalTrials.gov