Post-inflammatory Hyperpigmentation
Conditions
Keywords
Post-inflammatory Hyperpigmentation, Bioceramides, Niacinamide, Black Women, Facial Hyperpigmentation
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.
Interventions
DRUGNiacinamide 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.
Sponsors
Hospital Israelita Albert Einstein
COTY BRASIL COMERCIO S.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hyperpigmentation Severity Assessed by Hyperpigmentation Area Severity Scale (HASI) | 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 | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life Assessed by Melasma Quality of Life Scale (MelasQoL) | Baseline, Week 6, and Week 12 | 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. |
| Change in Quality of Life Assessed by Dermatology Life Quality Index (DLQI) | Baseline, Week 6, and Week 12 | 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. |
Countries
Brazil
Contacts
CONTACTJessica Andrade-Silva, PhD
CONTACTCamila Hernandes Pinheiro, PhD
PRINCIPAL_INVESTIGATORBruna Cestari de Azevedo, PhD
Hospital Israelita Albert Einstein
Outcome results
None listed