Development and Efficacy Tests of Cannabinoid, Prebiotic, and Postbiotic-based Face Serum and Cream (CPPFC-ET)
29 avril 2026 mis à jour par: PANAGOULA PAVLOU
Study of the Effectiveness of Moisturizing/Anti-aging Cosmetic Products for External Application in Healthy Volunteers
The study includes the evaluation of efficacy of face serum/cream in healthy volunteers aged 25-60 years with the following methods: a) self-assessment questionnaire b) biophysical organological measurements of skin elasticity, skin microtopography, transepidermal water loss and stratum corneum hydration.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
This study aimed to develop and evaluate a face serum and a face cream incorporating Cannabis extract, a prebiotic mixture containing Glycerin, Lactitol, Xylitol, and heat-treated Lactobacillus plantarum HEAL19, a non-viable probiotic (post-biotic) that retains structural components and functional benefits.
Efficacy was evaluated through a randomized, placebo-controlled study involving sixteen healthy female volunteers aged 24-53.
Each participant applied the active serum to one half of the face and a placebo one to the other, twice daily for 4 weeks (phase 1).
This was followed by a 4-week period during which a placebo cream was used by all volunteers.
Subsequently, each volunteer applied the active cream to one half of the face and a placebo one to the other, twice daily for 4 weeks (phase 2).
Assessments included transepidermal water loss, skin microtopography, elasticity, and hydration, alongside self-assessment questionnaire.
Type d'étude
Interventionnel
Inscription (Réel)
16
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.
Lieux d'étude
-
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Egaleo
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Athens, Egaleo, Grèce, 12243
- Panepistimioupolis Egaleo Park
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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
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
1. Healthy volunteers over 18 years old
Exclusion Criteria:
- Pregnant women
- Individuals who were currently taking hormonal therapy
- Individuals who were currently taking medications that cause photosensitivity
- Individuals with active lesions of any dermatological condition
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: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: FACE SERUM
Face serum with active components (cannabinoids, prebiotics, post-biotics) was applied twice a day on the half side of the face for 4 weeks (phase 1).
This was followed by a 4-week period during which a placebo cream was used.
|
APPLICATION OF THE SERUM ON THE HALF SIDE OF THE FACE TWICE A DAY
|
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Comparateur actif: FACE CREAM
Face cream with active components (cannabinoids, prebiotics, post-biotics) was applied twice a day on the half side of the face for 4 weeks (phase 2).
|
APPLICATION OF THE CREAM ON THE HALF SIDE OF THE FACE TWICE A DAY
|
|
Comparateur placebo: PLACEBO SERUM
Placebo serum without active components (cannabinoids, prebiotics, post-biotics) was applied twice a day on the half side of the face for 4 weeks (phase 1).
This was followed by a 4-week period during which a placebo cream was used.
|
APPLICATION OF THE SERUM ON THE HALF SIDE OF THE FACE TWICE A DAY
|
|
Comparateur placebo: PLACEBO CREAM
Placebo cream without active components (cannabinoids, prebiotics, post-biotics) was applied for 4-week period after phase 1 to all volunteers.
Then it was used during the second phase of the trial (4 weeks) on the half side of the face.
|
APPLICATION OF THE CREAM ON THE HALF SIDE OF THE FACE TWICE A DAY
THIS IS THE INTERMEDIATE PHASE BETWEEN PHASE A AND PHASE B, WHERE ALL VOLUTEERS APPLY THE PLACEBO CREAM ON BOTH SIDES OF THE FACE.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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ELASTICITY
Délai: Measurements were performed on Day 1 prior to serum application, and repeated after 4 weeks. Subsequent assessment was conducted 4 weeks (placebo cream application) later, followed by a final evaluation after an additional 4 weeks of cream usage.
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Skin elasticity was measured using the Cutometer 575 (Courage + Khazaka Electronic GmbH, Cologne, Germany).
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Measurements were performed on Day 1 prior to serum application, and repeated after 4 weeks. Subsequent assessment was conducted 4 weeks (placebo cream application) later, followed by a final evaluation after an additional 4 weeks of cream usage.
|
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HYDRATION
Délai: Measurements were performed on Day 1 prior to serum application, and repeated after 4 weeks. Subsequent assessment was conducted 4 weeks (placebo cream application) later, followed by a final evaluation after an additional 4 weeks of cream usage.
|
Stratun Corneum hydration was measured using the Corneometer ® CM 825 (Courage + Khazaka Electronic GmbH, Cologne, Germany).
|
Measurements were performed on Day 1 prior to serum application, and repeated after 4 weeks. Subsequent assessment was conducted 4 weeks (placebo cream application) later, followed by a final evaluation after an additional 4 weeks of cream usage.
|
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SKIN MICROTOPOGRAPHY
Délai: Measurements were performed on Day 1 prior to serum application, and repeated after 4 weeks. Subsequent assessment was conducted 4 weeks (placebo cream application) later, followed by a final evaluation after an additional 4 weeks of cream usage.
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The Skin Visioscan VC 98 (Courage + Khazaka Electronic GmbH, Cologne, Germany) was used to visualize the skin microtopography using a UVA camera.
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Measurements were performed on Day 1 prior to serum application, and repeated after 4 weeks. Subsequent assessment was conducted 4 weeks (placebo cream application) later, followed by a final evaluation after an additional 4 weeks of cream usage.
|
|
TRANSEPIDERMAL WATER LOSS
Délai: Measurements were performed on Day 1 prior to serum application, and repeated after 4 weeks. Subsequent assessment was conducted 4 weeks (placebo cream application) later, followed by a final evaluation after an additional 4 weeks of cream usage.
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Transepidermal water loss was measured using the MPA 5 TEWAMETER (Courage + Khazaka Electronic GmbH, Cologne, Germany).
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Measurements were performed on Day 1 prior to serum application, and repeated after 4 weeks. Subsequent assessment was conducted 4 weeks (placebo cream application) later, followed by a final evaluation after an additional 4 weeks of cream usage.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: ATHANASIA VARVARESOU, PROFESSOR, University of West Attica
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)
16 janvier 2023
Achèvement primaire (Réel)
30 mai 2023
Achèvement de l'étude (Réel)
30 septembre 2023
Dates d'inscription aux études
Première soumission
22 avril 2026
Première soumission répondant aux critères de contrôle qualité
29 avril 2026
Première publication (Réel)
4 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 avril 2026
Dernière vérification
1 avril 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 3349/16-01-2023
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
All IPD that underlie results in a publication
Délai de partage IPD
Beginning right after the approval of clinical trial and ending 5 years after the publication of results
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
- RSE
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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