Clinical Evaluation of an Atopic Skin Product Containing Picea Abies Resin Extract
4 mai 2026 mis à jour par: Repolar Pharmaceuticals Oy
Clinical-Instrumental Evaluation of the Efficacy of Two Cosmetic Products in Comparison: Placebo Controlled Study
This study evaluates the repairing efficacy of a cosmetic cream containing Picea abies extract compared to a placebo (cream without extract) and a benchmark product. The trial involves 60 healthy subjects (aged 18-60) with atopy-prone and sensitive skin.
Over a 21-day period, the primary objective is to measure improvements in skin barrier function via transepidermal water loss (TEWL) and skin moisturization. A dermatologist will also assess soothing effects by evaluating skin dryness, redness, and itching sensations. Secondary objectives include measuring skin inflammation markers (TNFα, TSLP, and TARC) and subject-perceived efficacy through self-assessment questionnaires.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
This is a multi-site, randomized, placebo-controlled, and benchmark-controlled clinical trial designed to evaluate the repairing and soothing efficacy of a cosmetic cream containing Picea abies extract. The study is conducted on 60 healthy male and female subjects (66 enrolled to account for a 10% dropout rate) aged 18 to 60 years who exhibit atopy-prone and sensitive skin.
Subjects are randomized into three parallel groups (N=20 per group):
Test Product: Atopic cream with Picea abies extract.
Placebo: Atopic cream without Picea abies extract.
Benchmark: A commercially available reference cream.
The intervention consists of applying the assigned product twice daily to clean, dry skin on the face and body for a duration of 21 days.
Clinical and instrumental evaluations are performed at baseline (T0) and after 21 days (T21). Instrumental assessments include the measurement of Transepidermal Water Loss (TEWL) and skin moisturization levels. Clinical evaluations are conducted by a dermatologist to assess physical signs (dryness, desquamation, redness) and functional signs (stinging, itching, burning, and tightness). Additionally, skin inflammation markers (TNFα, TSLP, and TARC) are dosed to evaluate the biological effect on skin barrier inflammation. Subjective efficacy is captured through a standardized self-assessment questionnaire.
Type d'étude
Interventionnel
Inscription (Réel)
66
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
-
-
Pavia
-
San Martino Siccomario, Pavia, Italie, 27028
- Complife Italia S.r.l
-
-
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:
- Healthy male and female subjects aged 18 to 60 years.
- Caucasian ethnicity.
- Subjects with atopy-prone skin on cheekbones and forearms, characterized by sensitive/reactive skin, redness, or itching.
- Transepidermal water loss (TEWL) thresholds at screening: Cheekbones ≥ 20 g/m^2/h and Forearms ≥10 g/m^2/h.
- Stable pharmacological therapy for at least one month without planned changes.
- Subjects aware of study procedures and having signed an informed consent form.
Exclusion Criteria:
- Acute or chronic diseases liable to interfere with study data or subject safety.
- Participation in other clinical trials or insufficient washout period (14 days).
- Known hypersensitivity or allergy to any ingredients in the test products.
- Use of pharmacological treatments considered incompatible with the study requirements.
- Presence of skin diseases that could interfere with instrumental measurements.
- Pregnant or breastfeeding women, or women of childbearing potential unwilling to use precautions to avoid pregnancy.
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: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: The Active Product
Atopic cream with Picea abies extract
|
Base cosmetic formulation identical to the test product but without the active Picea abies resin extract.
Applied twice daily on clean and dry skin of the face and body for 21 days.
Autres noms:
Commercially available emollient cream (Aqualan-L) used as an active comparator.
Applied twice daily on clean and dry skin of the face and body for 21 days.
Autres noms:
|
|
Comparateur placebo: The Placebo
Atopic cream without Picea abies extract
|
Commercially available emollient cream (Aqualan-L) used as an active comparator.
Applied twice daily on clean and dry skin of the face and body for 21 days.
Autres noms:
Cosmetic cream containing Picea abies extract.
Applied twice daily on clean and dry skin of the face and body for 21 days.
Autres noms:
|
|
Comparateur actif: Aqualan-L
Subjects apply the benchmark cream (Aqualan-L) twice daily on clean and dry skin of the face and body for 21 days.
|
Base cosmetic formulation identical to the test product but without the active Picea abies resin extract.
Applied twice daily on clean and dry skin of the face and body for 21 days.
Autres noms:
Cosmetic cream containing Picea abies extract.
Applied twice daily on clean and dry skin of the face and body for 21 days.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change From Baseline in Transepidermal Water Loss (TEWL) on Cheekbones at Day 21
Délai: Baseline (T0) and Day 21 (T21±2)
|
Transepidermal water loss (TEWL) on the cheekbones will be measured using a Tewameter.
The outcome will be reported as the change from baseline to Day 21.
Values are expressed in g/m²/h.
|
Baseline (T0) and Day 21 (T21±2)
|
|
Change From Baseline in Transepidermal Water Loss (TEWL) on Forearms at Day 21
Délai: Baseline (T0) and Day 21 (T21±2)
|
Transepidermal water loss (TEWL) on the forearms will be measured using a Tewameter.
The outcome will be reported as the change from baseline to Day 21.
Values are expressed in g/m²/h.
|
Baseline (T0) and Day 21 (T21±2)
|
|
Change From Baseline in Skin Moisturization on Cheekbones at Day 21
Délai: Baseline (T0) and Day 21 (T21±2)
|
Skin moisturization on the cheekbones will be evaluated using a Corneometer.
The outcome will be reported as the change from baseline to Day 21.
Values are expressed in corneometric units (c.u.).
|
Baseline (T0) and Day 21 (T21±2)
|
|
Change From Baseline in Skin Moisturization on Forearms at Day 21
Délai: Baseline (T0) and Day 21 (T21±2)
|
Skin moisturization on the forearms will be evaluated using a Corneometer.
The outcome will be reported as the change from baseline to Day 21.
Values are expressed in corneometric units (c.u.).
|
Baseline (T0) and Day 21 (T21±2)
|
|
Change From Baseline in Skin Dryness Score at Day 21
Délai: Baseline (T0) and Day 21 (T21±2)
|
Skin dryness will be assessed using the study-defined 5-point clinical score: 0 = none, 1 = very mild, 2 = mild, 3 = moderate, and 4 = severe.
Higher scores indicate greater severity.
The outcome will be reported as the change from baseline to Day 21.
|
Baseline (T0) and Day 21 (T21±2)
|
|
Change From Baseline in Skin Desquamation Score at Day 21
Délai: Baseline (T0) and Day 21 (T21±2)
|
Skin desquamation will be assessed using the study-defined 5-point clinical score: 0 = none, 1 = very mild, 2 = mild, 3 = moderate, and 4 = severe.
Higher scores indicate greater severity.
The outcome will be reported as the change from baseline to Day 21.
|
Baseline (T0) and Day 21 (T21±2)
|
|
Change from Baseline in Itching Sensation Score at Day 21
Délai: Baseline (T0) and Day 21 (T21±2)
|
Itching sensation will be assessed using the study-defined clinical score: 0 = absent itching, 1 = very mild itching, 2 = mild itching, 3 = moderate itching, 4 = severe itching.
The outcome will be reported as change from baseline to Day 21.
|
Baseline (T0) and Day 21 (T21±2)
|
|
Change from Baseline in Skin Redness Score at Day 21
Délai: Baseline (T0) and Day 21 (T21±2)
|
Skin redness will be assessed using the study-defined clinical score: 0 = absent redness, 1 = very mild redness, 2 = mild redness, 3 = moderate redness, 4 = severe redness.
The outcome will be reported as change from baseline to Day 21.
|
Baseline (T0) and Day 21 (T21±2)
|
|
Change From Baseline in Stinging Sensation Score at Day 21
Délai: Baseline (T0) and Day 21 (T21±2)
|
Stinging sensation will be assessed using the study-defined 5-point clinical score: 0 = none, 1 = very mild, 2 = mild, 3 = moderate, and 4 = severe.
Higher scores indicate greater severity.
The outcome will be reported as the change from baseline to Day 21.
|
Baseline (T0) and Day 21 (T21±2)
|
|
Change From Baseline in Burning Sensation Score at Day 21
Délai: Baseline (T0) and Day 21 (T21±2)
|
Burning sensation will be assessed using the study-defined 5-point clinical score: 0 = none, 1 = very mild, 2 = mild, 3 = moderate, and 4 = severe.
Higher scores indicate greater severity.
The outcome will be reported as the change from baseline to Day 21.
|
Baseline (T0) and Day 21 (T21±2)
|
|
Change From Baseline in Skin Tightness Score at Day 21
Délai: Baseline (T0) and Day 21 (T21±2)
|
Skin tightness will be assessed using the study-defined 5-point clinical score: 0 = none, 1 = very mild, 2 = mild, 3 = moderate, and 4 = severe.
Higher scores indicate greater severity.
The outcome will be reported as the change from baseline to Day 21.
|
Baseline (T0) and Day 21 (T21±2)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Maryam Ghanbarirad, Ph.D., Repolar Pharmaceuticals Oy
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)
5 janvier 2026
Achèvement primaire (Réel)
18 mars 2026
Achèvement de l'étude (Réel)
18 mars 2026
Dates d'inscription aux études
Première soumission
24 avril 2026
Première soumission répondant aux critères de contrôle qualité
4 mai 2026
Première publication (Réel)
7 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
7 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 mai 2026
Dernière vérification
1 avril 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- IT0000844/25 rev02
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Individual participant data (IPD) are considered proprietary to the Sponsor.
To protect intellectual property and maintain commercial confidentiality, there are currently no plans to share de-identified IPD with external researchers.
Aggregated results and summary data will be made available through the clinical trial registry and potentially via peer-reviewed publication.
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 .