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Study on the Functional Impact of Cosmetics on Improving Self-Esteem and Quality of Life in Black Women

2 juin 2026 mis à jour par: Hospital Israelita Albert Einstein

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

60

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Brésil
    • São Paulo
      • São Paulo, São Paulo, Brésil, 05652-900
        • Recrutement
        • Hospital israelita Albert Einstein
        • Contact:
        • Contact:
        • Chercheur principal:
          • Bruna Cestari de Azevedo, PhD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Intervention

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.
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Hyperpigmentation Severity Assessed by Hyperpigmentation Area Severity Scale (HASI)
Délai: 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.
Baseline, Week 6, and Week 12
Visual Assessment of Post-Inflammatory Hyperpigmentation Using Standardized Facial Photography
Délai: 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.
Baseline, Week 6, and Week 12
Change in Hyperpigmentation Severity Assessed by Investigator's Global Assessment (IGA)
Délai: 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.
Baseline, Week 6, and Week 12

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Quality of Life Assessed by Melasma Quality of Life Scale (MelasQoL)
Délai: 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.
Baseline, Week 6, and Week 12
Change in Quality of Life Assessed by Dermatology Life Quality Index (DLQI)
Délai: 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.
Baseline, Week 6, and Week 12

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hospital Israelita Albert Einstein

Collaborateurs

COTY BRASIL COMERCIO S.A.

Les enquêteurs

  • Chercheur principal: Bruna Cestari de Azevedo, PhD, Hospital israelita Albert Einstein

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

19 mars 2026

Achèvement primaire (Estimé)

31 octobre 2026

Achèvement de l'étude (Estimé)

31 octobre 2026

Dates d'inscription aux études

Première soumission

25 mai 2026

Première soumission répondant aux critères de contrôle qualité

25 mai 2026

Première publication (Réel)

1 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 juin 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • COTY_10772

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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