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New treatment option for Post-inflammatory Hyperpigmentation
Official title Study on the Functional Impact of Cosmetics on Improving Self-Esteem and Quality of Life in Black Women
ClinicalTrials.gov ID: NCT07618572
What this study is testing
What is Niacinamide and Bioceramide-Based Skincare Regimen?
Niacinamide and Bioceramide-Based Skincare Regimen is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for post-inflammatory hyperpigmentation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55, women only
You may be able to join 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...
You likely can't join 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...
- 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
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.