A Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Participants (El Porto Ex-US)
25 juin 2026 mis à jour par: Kenvue Brands LLC
A Monocentric and Open-Label Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Research Participants
The study aims to evaluate the efficacy of a facial sunscreen under two experimental conditions-untinted and tinted-in improving facial spots (melasma and solar lentigines/post-inflammatory hyperpigmentation) after 8 weeks of product use under normal conditions by adult participants.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
152
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
- Nom: Kenvue Global Clinical Operations
- Numéro de téléphone: 18779295131
- E-mail: KenvueClinical_KV@kenvue.com
Lieux d'étude
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São Paulo
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Campinas, São Paulo, Brésil, 13084-791
- Recrutement
- ALS Beauty & Personal Care Ltda
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Contact:
- Gabrielli Brianezi
- Numéro de téléphone: +551937898600
- E-mail: gabrielli.brianezi@alsglobal.com
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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
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
- Able to understand and follow study instructions
- Fitzpatrick skin types I-VI
Presence of facial hyperpigmentation, such as:
- Mild to moderate melasma, or
- Visible dark spots (e.g., solar lentigines or post-inflammatory hyperpigmentation)
- Willing to comply with study procedures and product use
- For subjects in applicable groups: willing to use assigned sunscreen product
Exclusion Criteria:
- Known sensitivity or allergy to cosmetic or skincare products
- Skin conditions or lesions in the study area that could interfere with evaluation (e.g., active dermatitis, infections, significant irritation, or extensive scarring)
- Use of medications or products that may interfere with study evaluations
- Recent cosmetic or dermatological procedures in the study area (e.g., chemical peels, laser treatments, invasive procedures)
- Excessive sun exposure or use of tanning beds immediately prior to or during the study
- Pregnancy or intention to become pregnant during the study
- Participation in another clinical study within a recent period
- Any condition or situation that, in the investigator's judgment, may interfere with study participation or evaluation of results
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: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Group I: Melasma/Untinted
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Participants will apply the facial sunscreen on the face at least twice daily for 56 days
|
|
Expérimental: Group I: Melasma/Tinted
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Participants will apply the facial sunscreen on the face at least twice daily for 56 days
|
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Expérimental: Group II: Solar Lentigo and Post-Inflammatory Hyperpigmentation / Untinted
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Participants will apply the facial sunscreen on the face at least twice daily for 56 days
|
|
Expérimental: Group II: Solar Lentigo and Post-Inflammatory Hyperpigmentation / Tinted
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Participants will apply the facial sunscreen on the face at least twice daily for 56 days
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Clinical efficacy of change in hyperpigmentation assessed via dermatological evaluation
Délai: Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Instrumental measurements with the Chroma Meter CR 400 (Konica Minolta)
Délai: Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
|
Measurements will be taken using the Chroma Meter® CR 400 to evaluate the color intensity of the dark spot (Melasma, Solar Lentigo, or Post-Inflammatory Hyperpigmentation) in comparison to the measurement of an adjacent area (without a spot).
|
Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Capture of facial images using the Visia-CR® Facial Imaging Booth (Canfield Scientific, Inc.)
Délai: Before, immediately after the first application, and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
|
Facial images will be captured using the Visia CR® Facial Imaging Booth (Canfield Scientific, Inc.) for analysis of the intensity and size of the spot (Melasma, Solar Spot, or Post-Inflammatory Hyperpigmentation), as well as the overall uniformity of skin tone.
|
Before, immediately after the first application, and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
|
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Participants' quality of life regarding facial spots for participants with Melasma assessed through a Quality of Life Questionnaire (MELASQoL)
Délai: Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
|
Melasma Quality of Life Scale (MELASQoL) will only be answered by participants enrolled in Melasma group. The participant will answer a questionnaire with 10 questions regarding the condition of their skin, using a rating scale from 1 to 7, in which: 1 means "not at all bothered" and 7 means "bothered all the time". A total score will be generated by summing the scores of the 10 questions answered by the participant. The total score ranges from 10 to 70. The lower the score, the better the participant's quality of life. |
Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
|
|
Participants' quality of life regarding facial spots for participants with Solar Lentigo or Post-Inflammatory Hyperpigmentation assessed through a Quality of Life Questionnaire (DLQI)
Délai: Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
|
Dermatology Life Quality Index (DLQI) will only be answered by participants selected for the Solar Lentigo/PIH Group.
The participant will answer a questionnaire with 10 questions regarding the impact of their skin on their quality of life.
Each question is scored on a four-point Likert scale: very much = 3 points, much = 2 points, a little = 1 point and nothing/not relevant = 0 points.
Questions answered as nothing and not relevant are equivalent to 0 points.
The total score ranges from 0 to 30.
The lower the score, the better the participant's quality of life.
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Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Perceived efficacy assessed through perception questionnaires completed by the research participants
Délai: After Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Participants will answer a questionnaire evaluating their individual opinion about the Investigational Product used.
Questionnaire consists of 9 questions which should be answered in a 5-point scale of agreement (such as ranging from "Strongly Disagree" to "Strongly Agree").
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After Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Open emotional testimonial written by the participant at the end of IP use
Délai: After Visit 4 (56+2 days) of IP use
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Consists of an open-ended, narrative question in which the participant provides a brief statement regarding their experience with the use of their respective Investigational Product.
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After Visit 4 (56+2 days) of IP use
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
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)
2 juin 2026
Achèvement primaire (Estimé)
25 septembre 2026
Achèvement de l'étude (Estimé)
25 septembre 2026
Dates d'inscription aux études
Première soumission
1 juin 2026
Première soumission répondant aux critères de contrôle qualité
25 juin 2026
Première publication (Réel)
1 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
1 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
25 juin 2026
Dernière vérification
23 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CS2026SK100350
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
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
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