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Efficacy Evaluation of a Cosmetic Product for Facial Hyperpigmentation (HYPERPIG)

15 septembre 2026 mis à jour par: Brainfarma Industria Química e Farmacêutica S/A

Evaluation of the Efficacy of a Cosmetic Product for the Reduction of Facial Hyperpigmentation: A Clinical, Subjective, and Instrumental Study

This is a single-center, single-blind clinical study designed to evaluate the efficacy of a depigmenting gel cream through clinical, subjective, and instrumental assessments. A total of 40 female participants, aged 30 to 60 years, will be enrolled and followed for 90 days while using the study product.Participants will be assigned to one of two groups. Group I will include 20 participants with facial hyperpigmentation, including post-inflammatory hyperpigmentation and solar lentigines, representing Fitzpatrick skin phototypes I to VI, with at least one participant from each phototype. Group II will include 20 participants with moderate or greater melasma, as assessed by the modified Melasma Area and Severity Index (mMASI), representing Fitzpatrick skin phototypes II to V.

The study aims to evaluate the product's effectiveness in reducing facial hyperpigmentation and improving skin appearance over the treatment period.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

40

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

Lieux d'étude

  • Brésil
    • São Paulo
      • Osasco, São Paulo, Brésil, 06023-070
        • Recrutement
        • Grupo Medcin
        • Contact:
        • Chercheur principal:
          • Sergio Schalka

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

Oui

La description

Inclusion Criteria:

  • Female participants aged 30 to 60 years.
  • Group I: Participants with Fitzpatrick skin phototypes I to VI, with at least one participant from each phototype category. Participants with facial hyperpigmentation, including post-inflammatory hyperpigmentation and solar lentigines.
  • Group II: Participants with moderate or greater melasma, as assessed by the modified Melasma Area and Severity Index (mMASI), and Fitzpatrick skin phototypes II to V.
  • Willingness to comply with all study procedures and attend scheduled on-site visits and assessments.
  • Willingness to comply with study procedures and be available for remote contact (telehealth) at scheduled times.
  • Ability to understand the study requirements, provide written informed consent, and sign the informed consent form.

Exclusion Criteria:

  • Pregnant or breastfeeding women, or women at risk of becoming pregnant during the study.
  • Use of anti-inflammatory, immunosuppressive, or antihistamine medications within 3 weeks prior to screening.
  • Skin conditions or marks in the study area that may interfere with the evaluation of skin reactions, including vascular malformations, scars, excessive hair growth, multiple nevi, or sunburn.
  • History of atopic conditions or allergy to cosmetic products.
  • Active skin diseases and/or lesions in the assessment area.
  • Immunosuppression due to medication use or active disease.
  • Uncontrolled endocrine disorders.
  • Relevant medical history or current evidence of alcohol or substance abuse.
  • Known history or suspected intolerance to products of the same category as the study product.
  • Intense sun exposure within 15 days prior to assessment.
  • Aesthetic or dermatological treatments within 4 weeks prior to assessment.
  • Any other condition that, in the investigator's opinion, may interfere with study participation or justify exclusion from the study.

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: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Facial Hyperpigmentation Group
Female participants aged 30 to 60 years with facial hyperpigmentation, including post-inflammatory hyperpigmentation and solar lentigines, Fitzpatrick skin phototypes I to VI, with at least one participant from each phototype. Participants will use the depigmenting gel cream for 90 days.
Autre: Blancy Pro
Blancy Pro is a depigmenting gel cream intended to reduce facial hyperpigmentation and improve skin appearance. Participants will use the product for 90 days, and efficacy will be assessed through clinical, subjective, and instrumental evaluations.
Expérimental: Melasma Group
Female participants aged 30 to 60 years with moderate or greater melasma, as assessed by the modified Melasma Area and Severity Index (mMASI), Fitzpatrick skin phototypes II to V. Participants will use the depigmenting gel cream for 90 days.
Autre: Blancy Pro
Blancy Pro is a depigmenting gel cream intended to reduce facial hyperpigmentation and improve skin appearance. Participants will use the product for 90 days, and efficacy will be assessed through clinical, subjective, and instrumental evaluations.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Facial Hyperpigmentation Assessed by Chromameter (L* Parameter)
Délai: Baseline (Day 0), Day 30, Day 60, and Day 90
Evaluation of the efficacy of the investigational product in improving facial hyperpigmentation in participants with post-inflammatory hyperpigmentation, solar lentigines, and melasma through colorimetric measurements obtained using the Chromameter® device. Changes in the L* parameter will be assessed over time, with higher values indicating skin lightening.
Baseline (Day 0), Day 30, Day 60, and Day 90

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in the Number of Facial Pigmented Lesions Assessed by VISIA® Imaging System
Délai: Baseline (Day 0), Day 30, Day 60, and Day 90
Evaluation of the efficacy of the investigational product in reducing the number of facial pigmented lesions in participants with post-inflammatory hyperpigmentation, solar lentigines, and melasma through image analysis using the VISIA® imaging system (Canfield Software).
Baseline (Day 0), Day 30, Day 60, and Day 90
Change in Facial Skin Tone Uniformity Assessed by VISIA® Image Analysis
Délai: Baseline (Day 0), Day 30, Day 60, and Day 90
Evaluation of the efficacy of the investigational product in improving facial skin tone uniformity in participants with post-inflammatory hyperpigmentation, solar lentigines, and melasma through image analysis using the VISIA® system and Image-Pro Plus software.
Baseline (Day 0), Day 30, Day 60, and Day 90
Change in Facial Skin Hydration Assessed by Corneometer®
Délai: Baseline (Day 0), Day 30, Day 60, and Day 90
Evaluation of the ability of the investigational product to improve facial skin hydration in participants with post-inflammatory hyperpigmentation, solar lentigines, and melasma through instrumental measurements obtained using the Corneometer® device.
Baseline (Day 0), Day 30, Day 60, and Day 90
Maintenance of Skin pH Assessed by Skin pHmeter®
Délai: Baseline (Day 0), Day 30, Day 60, and Day 90
Evaluation of the maintenance of skin pH during use of the investigational product in participants with post-inflammatory hyperpigmentation, solar lentigines, and melasma through instrumental measurements obtained using the Skin pHmeter®.
Baseline (Day 0), Day 30, Day 60, and Day 90
Maintenance of Skin Barrier Function Assessed by Tewameter®
Délai: Baseline (Day 0), Day 30, Day 60, and Day 90
Evaluation of the maintenance of skin barrier function during use of the investigational product through instrumental measurements of transepidermal water loss (TEWL) using the Tewameter® device.
Baseline (Day 0), Day 30, Day 60, and Day 90
Safety of the Investigational Product Under Normal Conditions of Use
Délai: Day 30, Day 60, and Day 90
Evaluation of the safety and tolerability of the investigational product under normal conditions of use in the target population through clinical monitoring of adverse reactions and tolerability assessments.
Day 30, Day 60, and Day 90
Clinical Improvement of Facial Hyperpigmentation Assessed by a 5-Point Scale
Délai: Baseline (Day 0), Day 30, Day 60, and Day 90
Evaluation of the efficacy of the investigational product in improving facial hyperpigmentation in participants with post-inflammatory hyperpigmentation, solar lentigines, and melasma through clinical assessment using a 5-point evaluation scale, ranging from 1 (Very Severe) to 5 (Absent). Higher scores indicate less severe pigmentation and a better clinical outcome.
Baseline (Day 0), Day 30, Day 60, and Day 90
Change in Melasma Severity Assessed by the Modified Melasma Area and Severity Index (mMASI)
Délai: Baseline (Day 0), Day 30, Day 60, and Day 90
Evaluation of the efficacy of the investigational product in improving melasma in participants diagnosed with melasma using the Modified Melasma Area and Severity Index (mMASI). The mMASI assesses melasma severity across four facial regions: forehead, right malar region, left malar region, and chin, weighted according to their proportional facial areas. Scores range from 0 to 24, with 0 indicating no melasma and 24 indicating the most severe melasma. Higher scores indicate worse disease severity, and lower scores indicate improvement. The mMASI score is calculated using the formula: mMASI = 0.3(AF×PF) + 0.3(AMD×PMD) + 0.3(AME×PME) + 0.1(AM×PM).
Baseline (Day 0), Day 30, Day 60, and Day 90
Participant-Perceived Efficacy and Product Performance Assessed by Subjective Questionnaire
Délai: Day 14, Day 30, Day 60, and Day 90
Evaluation of the perceived efficacy and performance of the investigational product from the participants' perspective using a Likert Scale questionnaire administered under real-world conditions of use. The Likert Scale ranges from "Strongly Disagree" to "Strongly Agree".
Day 14, Day 30, Day 60, and Day 90
Change in Quality of Life Assessed by the MelasQoL Questionnaire
Délai: Baseline (Day 0), Day 30, Day 60, and Day 90
Evaluation of the impact of treatment on the quality of life of participants with melasma using the Melasma Quality of Life Scale (MelasQoL). The MelasQoL assesses the impact of melasma on daily life and well-being using ordered response categories ranging from "Not bothered at all" to "Bothered all of the time." Responses indicating less bother reflect better quality of life, while responses indicating greater bother reflect worse quality of life.
Baseline (Day 0), Day 30, Day 60, and Day 90

Collaborateurs et enquêteurs

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

Parrainer

Brainfarma Industria Química e Farmacêutica S/A

Les enquêteurs

  • Chercheur principal: Sergio Schalka, Grupo Medcin

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)

13 juillet 2026

Achèvement primaire (Estimé)

21 janvier 2027

Achèvement de l'étude (Estimé)

21 janvier 2027

Dates d'inscription aux études

Première soumission

12 août 2026

Première soumission répondant aux critères de contrôle qualité

12 août 2026

Première publication (Réel)

17 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 septembre 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 26-0161-05

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

No plan has been established to share individual participant data (IPD) collected during this study. Participant confidentiality and privacy will be protected in accordance with applicable regulations and institutional policies.

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

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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