Post-inflammatory HyperpigmentationNCT07618572
Study on the Functional Impact of Cosmetics on Improving Self-Esteem and Quality of Life in Black Women
A study testing Niacinamide and Bioceramide-Based Skincare Regimen in people with Post-inflammatory Hyperpigmentation, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Post-inflammatory Hyperpigmentation
- What is being tested?
- Niacinamide and Bioceramide-Based Skincare Regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 19 Mar 2026to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05652-900
Camila Hernandes Pinheiro, PhD, +5511952960024, camila.hernandes@einstein.br
Jessica Andrade-Silva, PhD, +55975295921, jessica.as@einstein.br
About this study
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:
Read more
- 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
- Being tested
- Niacinamide and Bioceramide-Based Skincare Regimen
- Keywords
- Post-inflammatory Hyperpigmentation, Bioceramides, Niacinamide, Black Women, Facial Hyperpigmentation
- Medical subject headings
- Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niacinamide and Bioceramide-Based Skincare RegimenDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Drug: Niacinamide and Bioceramide-Based Skincare Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 6, and Week 12
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, Week 6, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start19 Mar 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-inflammatory HyperpigmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- COTY BRASIL COMERCIO S.A.
- Responsible party
- Sponsor
- Investigators
- Bruna Cestari de Azevedo, PhD, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618572
- Sponsor's protocol ID
- COTY_10772
- Status last verified
- May 2026
- First submitted
- 25 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Functional Impact of Cosmetics on Improving Self-Esteem and Quality of Life in Black Women
- ClinicalTrials.gov ID
- NCT07618572
- Acronym / sponsor ID
- COTY_10772
- Conditions
- Post-inflammatory Hyperpigmentation
- Keywords
- Post-inflammatory Hyperpigmentation, Bioceramides, Niacinamide, Black Women, Facial Hyperpigmentation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- COTY BRASIL COMERCIO S.A.
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Niacinamide and Bioceramide-Based Skincare RegimenParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Niacinamide and Bioceramide-Based Skincare RegimenA 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. | Drug | Intervention |
Primary outcome
Change in Hyperpigmentation Severity Assessed by Hyperpigmentation Area Severity Scale (HASI)
Time frame: Baseline, Week 6, and Week 12
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.
Visual Assessment of Post-Inflammatory Hyperpigmentation Using Standardized Facial Photography
Time frame: Baseline, Week 6, and Week 12
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.
Change in Hyperpigmentation Severity Assessed by Investigator's Global Assessment (IGA)
Time frame: Baseline, Week 6, and Week 12
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.
2 secondary outcomes
Change in Quality of Life Assessed by Melasma Quality of Life Scale (MelasQoL)
Time frame: Baseline, Week 6, and Week 12
Change in Quality of Life Assessed by Dermatology Life Quality Index (DLQI)
Time frame: Baseline, Week 6, and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bruna Cestari de Azevedo, PhD principal investigator
Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Niacinamide and Bioceramide-Based Skincare Regimen in people with Post-inflammatory Hyperpigmentation, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Andrade-Silva, PhD (+55975295921, jessica.as@einstein.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hyperpigmentation Severity Assessed by Hyperpigmentation Area Severity Scale (HASI) (time frame: Baseline, Week 6, and Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.