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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Atopic Dermatitis; Dry Skin; Xerosis Due to Atopic Dermatitis
• Intervention / Treatment: Other: Ethanolic extract of propolis; Other: Crude propolis; Other: Vehicle ointment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Ethanolic extract of propolis; 3% ethanolic extract of propolis in ointment base; Other Names: EEP; Propolis extract; Bee propolis extract
Experimental: 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.	Other: Crude propolis; 5% micronized crude propolis in ointment base; Other Names: Bee glue; Raw propolis; Natural propolis; Micronized propolis
Placebo Comparator: Vehicle Ointment; Base ointment containing white soft paraffin 70%, liquid paraffin 20%, anhydrous lanolin 10%. No propolis. Applied twice daily for 4 weeks.	Other: Vehicle ointment; Ointment base without propolis; Other Names: Placebo ointment; Base ointment; Control ointment; White soft paraffin base

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinical Dryness Score	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pruritus Visual Analog Scale (VAS)	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Comfort Assessment	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	Self-reported assessment of ointment spreadability, greasiness, absorption, texture, and ease of application.	Week 2 and Week 4
Subject Satisfaction Score	Overall satisfaction with treatment using a Likert scale (1=Very dissatisfied, 5=Very satisfied).	Week 4
Standardized Clinical Photography	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

Collaborators and Investigators

• Sponsor: Manara University
• Investigators: Study Director: Mahmoud Bitar, BPharm St., Manara University; Study Director: Haya Farhat, BPharm St., Manara University; Study Director: Nagham Saleh, BPharm St., Manara University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2026
• Primary Completion (Actual): May 24, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 25, 2026
• First Submitted That Met QC Criteria: May 25, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: atopic dermatitis; propolis; skin barrier; dermocosmetic; topical ointment; xerosis; natural product; apitherapy; corticosteroid-sparing; bee product
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Pharmaceutical Preparations; Chemical Actions and Uses; Polymers; Macromolecular Substances; Specialty Uses of Chemicals; Pharmaceutic Aids; Biological Products; Complex Mixtures; Biopolymers; Plant Exudates; Resins, Plant; Propolis; Ointment Bases
• Other Study ID Numbers: SHAMNA-2026-027 (Registry Identifier: Syrian Scientific Society for Medicinal Herbs (SHAMNA)); MU-URO-260426-01 (Other Identifier: Manara University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Within 6 months following publication of primary results. Data will remain available indefinitely through the institutional repository.
• IPD Sharing Access Criteria: 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No