Study on the Functional Impact of Cosmetics on Improving Self-Esteem and Quality of Life in Black… (NCT07618572) | Clinical Trial Compass
RecruitingNot Applicable
Study on the Functional Impact of Cosmetics on Improving Self-Esteem and Quality of Life in Black Women
Brazil60 participantsStarted 2026-03-19
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Hyperpigmentation Severity Assessed by Hyperpigmentation Area Severity Scale (HASI)
Timeframe: Baseline, Week 6, and Week 12
2
Visual Assessment of Post-Inflammatory Hyperpigmentation Using Standardized Facial Photography
Timeframe: Baseline, Week 6, and Week 12
3
Change in Hyperpigmentation Severity Assessed by Investigator's Global Assessment (IGA)