An interventional study of Niacinamide and Bioceramide-Based Skincare Regimen in Post-inflammatory Hyperpigmentation, sponsored by Hospital Israelita Albert Einstein. Recruiting at 1 site in Brazil. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Hospital Israelita Albert Einstein · Not applicable, Interventional, and Treatment
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:
Participants will:
127 studies on the registry are indexed under Hyperpigmentation; 28 are open to participants now.
This study's planned enrollment of 60 is above the median of 32 across 113 interventional studies indexed under Hyperpigmentation.
Browse Hyperpigmentation studies →Hospital Israelita Albert Einstein is the lead sponsor of 147 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 6, and Week 12
Change in Quality of Life Assessed by Melasma Quality of Life Scale (MelasQoL)
The Melasma Quality of Life Scale (MelasQoL) will be used to assess quality of life related to post-inflammatory hyperpigmentation. The questionnaire consists of 10 items divided into three domains: emotional well-being, social life, and self-esteem/daily activities. Each item is scored from 1 (not bothered at all) to 7 (constantly bothered), with higher scores indicating worse quality of life. The MelasQoL is a validated instrument for assessing the impact of melasma and other pigmentary disorders on patients' quality of life.
Time frame: Baseline, Week 6, and Week 12
Change in Quality of Life Assessed by Dermatology Life Quality Index (DLQI)
The Dermatology Life Quality Index (DLQI) will be used to assess quality of life and self-esteem related to post-inflammatory hyperpigmentation. The questionnaire consists of 10 items covering six domains: symptoms, emotions, daily activities, work/school, social functioning, and treatment. Each item is scored from 0 (not at all/not relevant) to 3 (very much), with total scores ranging from 0 to 30. Higher scores indicate greater impairment in quality of life.
Time frame: Baseline, Week 6, and Week 12
Started Mar 2026 (actual). Primary completion is estimated for Oct 2026, 7 months after the start.
Of 37 non-industry interventional studies with no phase under Hyperpigmentation, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's planned 7 months is below that.
Counting every sponsor, half of 64 studies reached it within 7 months; a quarter within 3 and three quarters within 25.
How these figures are worked out, and which studies are left out of them.
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