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Dermocosmetic Evaluation of Propolis Ointments in Atopic-Prone Dry Skin (DEPRO)

25 mai 2026 mis à jour par: Chadi Khatib, Manara University

Comparative Dermocosmetic Evaluation of Crude Propolis and Ethanolic Extract of Propolis Ointments in Subjects With Atopic-Prone Dry Skin: An Exploratory Randomized Double-Blind Vehicle-Controlled Parallel-Group Study

The goal of this clinical trial is to learn if propolis ointments work to improve dry, atopic-prone skin in adults. Propolis is a natural substance made by honeybees. It will also learn about the safety of these ointments.

The main questions it aims to answer are:

Does propolis ointment lower dryness, scaling, and roughness better than a base ointment with no propolis? Is there a difference between crude propolis and ethanolic extract of propolis (EEP)?

Researchers will compare three ointments to see if they improve skin condition:

A propolis ointment made with 3% ethanolic extract A propolis ointment made with 5% crude propolis A base ointment with no propolis (look-alike)

Participants will:

Apply the ointment to dry skin areas twice a day for 4 weeks Visit the clinic 4 times: for screening, at the start, at week 2, and at week 4 Have their skin checked by a researcher using a standard dryness score Answer questions about skin comfort, itching, and satisfaction Have a patch test before starting to check for allergy to propolis

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

This exploratory dermocosmetic study is a graduation project conducted by pharmacy students at Manara University in collaboration with the Syrian Scientific Society for Medicinal Herbs (SHAMNA). It evaluates two propolis-based ointments against a vehicle control in adults with atopic-prone dry skin.

STUDENT INVESTIGATORS:

Mahmoud Bitar, Haya Farhat, Nagham Saleh - supervised by Chadi Khatib, PhD, Faculty of Pharmacy, Manara University.

RATIONALE:

Atopic-prone dry skin presents with chronic dryness, scaling, roughness, mild itching, and impaired barrier function. In Syria and similar settings, topical corticosteroids are frequently used for minor skin conditions, often through over-the-counter combination products whose steroid content is not clearly labeled. This study addresses the need for evidence-based, non-steroidal alternatives for mild xerotic and atopic-prone skin.

INTERVENTIONS:

Three ointments are prepared under GMP-like conditions with identical packaging and appearance:

  1. EEP Ointment 3%: ethanolic extract of propolis (3%), white soft paraffin (67%), liquid paraffin (20%), anhydrous lanolin (10%)
  2. Crude Propolis Ointment 5%: micronized crude propolis (5%), white soft paraffin (65%), liquid paraffin (20%), anhydrous lanolin (10%)
  3. Vehicle Ointment: white soft paraffin (70%), liquid paraffin (20%), anhydrous lanolin (10%)

Propolis is standardized by total phenolic content, total flavonoid content, and HPLC fingerprinting (reference compounds: CAPE, artepillin C, galangin, pinocembrin).

DESIGN:

Randomized, double-blind, vehicle-controlled, parallel-group. Allocation ratio 1:1:1. Computer-generated block randomization.

POPULATION:

Adults aged 18-60 years with atopic-prone dry skin or mild xerotic condition. Exclusion: acute eczema, infected dermatitis, psoriasis, known propolis/honey/lanolin allergy, pregnancy, breastfeeding, recent systemic corticosteroids (2 weeks), immunosuppressants (4 weeks), biologics (3 months), topical corticosteroids (1 week), topical calcineurin inhibitors (1 week), phototherapy (2 weeks).

PROCEDURES:

  • Visit 0: Screening, 48-hour patch test (forearm or upper back), informed consent
  • Visit 1 (Week 0): Randomization, baseline clinical photography, dryness score
  • Visit 2 (Week 2): Safety and cosmetic evaluation
  • Visit 3 (Week 4): Final evaluation

OUTCOMES:

Primary: Change in clinical dryness score (5-point scale: 0=None, 1=Very mild, 2=Mild, 3=Moderate, 4=Severe) from baseline to Week 4, assessing dryness, scaling, and roughness.

Secondary: Pruritus VAS (0-10), skin comfort (Likert 1-5), cosmetic acceptability, subject satisfaction (Likert 1-5), standardized clinical photography.

SAFETY:

Erythema, burning, stinging, edema, allergic dermatitis, irritation at each visit. Adverse events: mild (continue), moderate (monitor), severe (discontinue).

ANALYSIS:

Mixed-effects repeated measures model, Tukey post hoc, Fisher exact or Chi-square for categorical variables. Significance: p < 0.05. Software: SPSS, GraphPad Prism.

SAMPLE SIZE: 30 participants (10 per group).

COMPLIANCE: Package weighing, patient diary, usage frequency. Poor compliance: <80% adherence.

ETHICS: Declaration of Helsinki, GCP. Written informed consent. Approved by Biomedical Ethics Committee, Syrian Scientific Society for Medicinal Herbs (SHAMNA), approval SHAMNA-2026-027.

Type d'étude

Interventionnel

Inscription (Réel)

30

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

  • Syrie
      • Latakia, Syrie
        • Manara University, Faculty of Pharmacy

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

Non

La description

Inclusion Criteria:

  • Adults aged 18-60 years
  • Atopic-prone dry skin or mild xerotic skin condition
  • Mild-to-moderate skin dryness, scaling, roughness, and mild itching
  • No acute inflammatory skin disease
  • Ability to attend follow-up visits and comply with application instructions
  • Signed informed consent form

Exclusion Criteria:

  • Known allergy to propolis, honey, or bee products
  • Known allergy to lanolin
  • Acute eczema flare, infected dermatitis, psoriasis, seborrheic dermatitis, fungal infections, herpes simplex, or scabies
  • Pregnancy or breastfeeding
  • Recent use of systemic corticosteroids (within 2 weeks)
  • Recent use of immunosuppressants (within 4 weeks)
  • Recent use of biologics (within 3 months)
  • Recent use of topical corticosteroids (within 1 week)
  • Recent use of topical calcineurin inhibitors (within 1 week)
  • Recent phototherapy (within 2 weeks)
  • Severe systemic diseases not under control
  • Poor compliance or inability to cooperate
  • Use of other skin products during the study period

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: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: EEP Ointment 3%
Ointment containing 3% ethanolic extract of propolis, white soft paraffin 67%, liquid paraffin 20%, anhydrous lanolin 10%. Applied twice daily for 4 weeks.
Autre: Ethanolic extract of propolis
3% ethanolic extract of propolis in ointment base
Autres noms:
  • Faire un coup de pouce
  • Propolis extract
  • Bee propolis extract
Expérimental: Crude Propolis Ointment 5%
Ointment containing 5% micronized crude propolis, white soft paraffin 65%, liquid paraffin 20%, anhydrous lanolin 10%. Applied twice daily for 4 weeks.
Autre: Crude propolis
5% micronized crude propolis in ointment base
Autres noms:
  • Colle d'abeille
  • Raw propolis
  • Natural propolis
  • Micronized propolis
Comparateur placebo: Vehicle Ointment
Base ointment containing white soft paraffin 70%, liquid paraffin 20%, anhydrous lanolin 10%. No propolis. Applied twice daily for 4 weeks.
Autre: Vehicle ointment
Ointment base without propolis
Autres noms:
  • Pommade placebo
  • Base ointment
  • Control ointment
  • White soft paraffin base

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Clinical Dryness Score
Délai: Baseline (Week 0) and Week 4
Clinical assessment of skin dryness, scaling, and roughness using a 5-point scale where 0=None, 1=Very mild, 2=Mild, 3=Moderate, 4=Severe. Lower scores indicate improvement.
Baseline (Week 0) and Week 4

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Pruritus Visual Analog Scale (VAS)
Délai: Baseline (Week 0), Week 2, and Week 4
Self-reported itching intensity on a 0-10 scale, where 0=no itching and 10=worst possible itching.
Baseline (Week 0), Week 2, and Week 4

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Skin Comfort Assessment
Délai: Baseline (Week 0), Week 2, and Week 4
Self-reported assessment of skin tightness, burning, soothing sensation, and softness using a Likert scale (1=Very uncomfortable, 5=Very comfortable).
Baseline (Week 0), Week 2, and Week 4
Cosmetic Acceptability
Délai: Week 2 and Week 4
Self-reported assessment of ointment spreadability, greasiness, absorption, texture, and ease of application.
Week 2 and Week 4
Subject Satisfaction Score
Délai: Week 4
Overall satisfaction with treatment using a Likert scale (1=Very dissatisfied, 5=Very satisfied).
Week 4
Standardized Clinical Photography
Délai: Baseline (Week 0) and Week 4
Digital photography of affected skin areas under standardized lighting, distance, angle, and camera settings at baseline and Week 4 for visual comparison.
Baseline (Week 0) and Week 4

Collaborateurs et enquêteurs

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

Parrainer

Manara University

Les enquêteurs

  • Directeur d'études: Mahmoud Bitar, BPharm St., Manara University
  • Directeur d'études: Haya Farhat, BPharm St., Manara University
  • Directeur d'études: Nagham Saleh, BPharm St., Manara University

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)

15 avril 2026

Achèvement primaire (Réel)

24 mai 2026

Achèvement de l'étude (Estimé)

1 juin 2026

Dates d'inscription aux études

Première soumission

25 mai 2026

Première soumission répondant aux critères de contrôle qualité

25 mai 2026

Première publication (Réel)

1 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • SHAMNA-2026-027 (Identificateur de registre: Syrian Scientific Society for Medicinal Herbs (SHAMNA))
  • MU-URO-260426-01 (Autre identifiant: Manara University)

Plan pour les données individuelles des participants (IPD)

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

OUI

Description du régime IPD

De-identified individual participant data, study protocol, statistical analysis plan, and informed consent form will be shared with other researchers following publication of primary results. Clinical photographs will be excluded from shared datasets to protect participant privacy.

Délai de partage IPD

Within 6 months following publication of primary results. Data will remain available indefinitely through the institutional repository.

Critères d'accès au partage IPD

Available to researchers who provide a methodologically sound proposal and agree to data use terms. Requests should be directed to the corresponding author at chadi.khatib@gmail.com

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

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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