- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07695805
Evaluation of the Effect of Combined Use of Cosmetic Products for Dry and Itchy Skin.
Confirmation in Human Subjects of a Cosmetic Product Efficacy After Application in the Body Under Normal Conditions of Use.
The goal of this study is to learn if combined use of shower oleogel and body lotion works to improve skin itching and dryness in adults. It will also learn about its safety. The main question it aims to answer is:
• Does the products use improves skin hydration and itching? Researchers will compare shower oleogel and body lotion to a commercially available shower gel and the body lotion to see if the combined use is more efficient than use of body lotion alone.
Participants will:
- Use assigned products every day for 1 month
- Visit the CRO for checkups and tests on established schedule
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Contreiras
- Numéro de téléphone: +34 93 101 66 95
- E-mail: geral@phdtrials.com
Lieux d'étude
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Lisbon District
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Lisbon, Lisbon District, Le Portugal, 1750-182
- PhD Trials
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Contact:
- Contreiras
- Numéro de téléphone: +34 93 101 66 95
- E-mail: geral@phdtrials.com
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Age: 18-70 years old
- Gender: both
- Sensitive skin and 30% to 50% with atopic tendency (scored 8-12)
- With dry or very dry skin on the body
- With presence of itching due to different origins: contact/friction with fabrics, hard water, atopic tendency, dry skin, etc.
Exclusion Criteria:
- cutaneous marks on the experimental areas, which could interfere with the assessment of skin reactions (pigmentation troubles, scar elements, over-developed pilosity, ephelides and naevi in too great quantity, sunburn),
- allergy or reactivity to products of the same category than the tested one,
- with history of malignant melanomas (Dubreullh melanosis…)
- unbalanced hormonal treatment,
- forecast of initiation of an hormonal treatment or change of the usual hormonal treatment during the study or 3 months before the starting of the study,
- forecast of intensive sun or UVA exposure (UV lamps) during the test period,
- breast-feeding or pregnancy,
- treatment with Vitamin A acid or its derivatives stopped less than 3 months before the beginning of the study,
- treatment with anti-stretch, firming, slimming or anti-cellulite products stopped less than 3 months before the beginning of the study,
- diet stopped less than 3 months before the beginning of the study,
- drugs likely to produce an increase or reduction in body weight,
- under anti-cellulite treatment: mesotherapy, electrotherapy, ionisation, ultrasonotherapy, relaxation, acupuncture, hydrotherapy, lymphatic drainage, massage, sauna,…,
- neither antibiotic, anti-allergic, anti-inflammatory treatment nor treatment with patent medicines containing Vitamin A acid or its derivatives before and during the study (if therapeutic requirement: exclusion foreseen),
- systemic disorders: Cardiovascular, pulmonary, digestive, neurologic, psychiatric, genital, urinary, haematological, endocrine
- individuals who have undergone a bilateral mastectomy with lymph node removal, a unilateral mastectomy with lymph node removal within the last year, or a bilateral axillary lymph node removal,
- individuals with a history of immune deficiency or auto-immune disease, treated for malignancy within 6 months prior to enrollment or who are currently under treatment for asthma or diabetes,
- forecast of vaccination during the test period or last vaccination within 3 weeks before the study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: shower oleogel and body lotion
shower oleogel and body lotion will be used daily for 28 days
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Daily use of shower oleogel and body lotion for 28 days
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Comparateur actif: shower gel and body lotion
shower gel and body lotion will be used daily for 28 days
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Daily use of shower gel and body lotion
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Change from Baseline in the rate of skin hydration (capacitance measured by Corneometer) at 4 weeks
Délai: From enrollment to the end of the study at 4 weeks
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From enrollment to the end of the study at 4 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Change from Baseline in the rate of skin barrier function (TEWL evaluated by Tewameter) at 4 weeks.
Délai: From enrollment to the end of the study at 4 weeks
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From enrollment to the end of the study at 4 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Perdo Contreiras, PhD Trials
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- PhDES2851B
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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