NCT07618572 Study on the Functional Impact of Cosmetics on Improving Self-Esteem and Quality of Life in Black Women
| NCT ID | NCT07618572 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Israelita Albert Einstein |
| Condition | Post-inflammatory Hyperpigmentation |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-03-19 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-03-19 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
Bruna Cestari de Azevedo, PhD
PRINCIPAL INVESTIGATOR
Hospital Israelita Albert Einstein
Frequently Asked Questions
Who can join the NCT07618572 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 55 Years, studying Post-inflammatory Hyperpigmentation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07618572 currently recruiting?
Yes, NCT07618572 is actively recruiting participants. Contact the research team at jessica.as@einstein.br for enrollment information.
Where is the NCT07618572 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT07618572 clinical trial?
NCT07618572 is sponsored by Hospital Israelita Albert Einstein. The principal investigator is Bruna Cestari de Azevedo, PhD at Hospital Israelita Albert Einstein. The trial plans to enroll 60 participants.