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

Manara University

Status: Active, not recruiting

Conditions: Xerosis Due to Atopic Dermatitis; Atopic Dermatitis; Dry Skin

Treatments: Other: Vehicle ointment; Other: Crude propolis; Other: Ethanolic extract of propolis

Study type: Interventional

Funder types: Other

Identifiers

NCT07618234

SHAMNA-2026-027 (Registry Identifier)

MU-URO-260426-01 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups, including a placebo group

EEP Ointment 3%

Experimental group

Description:

Ointment containing 3% ethanolic extract of propolis, white soft paraffin 67%, liquid paraffin 20%, anhydrous lanolin 10%. Applied twice daily for 4 weeks.

Treatment:

Other: Ethanolic extract of propolis

Crude Propolis Ointment 5%

Experimental group

Description:

Ointment containing 5% micronized crude propolis, white soft paraffin 65%, liquid paraffin 20%, anhydrous lanolin 10%. Applied twice daily for 4 weeks.

Treatment:

Other: Crude propolis

Vehicle Ointment

Placebo Comparator group

Description:

Base ointment containing white soft paraffin 70%, liquid paraffin 20%, anhydrous lanolin 10%. No propolis. Applied twice daily for 4 weeks.

Treatment:

Other: Vehicle ointment