Dermocosmetic Evaluation of Propolis Ointments in Atopic-Prone Dry Skin

NCT07618234 | Active Not Recruiting

• 2 other identifiers: SHAMNA-2026-027MU-URO-260426-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Skin; Atopic Dermatitis; Xerosis Due to Atopic Dermatitis

Keywords

propolis; apitherapy; dermocosmetic; skin barrier; natural product; corticosteroid-sparing; atopic dermatitis; xerosis; topical ointment; bee product

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pruritus Visual Analog Scale (VAS)

  Baseline (Week 0), Week 2, and Week 4

Other Outcomes (4)

• Skin Comfort Assessment

  Baseline (Week 0), Week 2, and Week 4

• Cosmetic Acceptability

  Week 2 and Week 4

• Subject Satisfaction Score

  Week 4

Study Arms (3)

EEP Ointment 3%

EXPERIMENTAL

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

Crude Propolis Ointment 5%

EXPERIMENTAL

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

Vehicle Ointment

PLACEBO COMPARATOR

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

Other: Vehicle ointment

Interventions

Ethanolic extract of propolis OTHER

3% ethanolic extract of propolis in ointment base

Also known as: EEP, Propolis extract, Bee propolis extract

EEP Ointment 3%

Crude propolis OTHER

5% micronized crude propolis in ointment base

Also known as: Raw propolis, Natural propolis, Micronized propolis, Bee glue

Crude Propolis Ointment 5%

Vehicle ointment OTHER

Ointment base without propolis

Also known as: Placebo ointment, Base ointment, Control ointment, White soft paraffin base

Vehicle Ointment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Manara University: lead

Study Sites (1)

Manara University, Faculty of Pharmacy

Latakia, Syria

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Propolis; Ointment Bases

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures; Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Mahmoud Bitar, BPharm St.

  Manara University

  STUDY DIRECTOR

• Haya Farhat, BPharm St.

  Manara University

  STUDY DIRECTOR

• Nagham Saleh, BPharm St.

  Manara University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All study personnel including the statistician are blinded. An independent pharmacist prepares coded packages.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Three parallel groups with no crossover between interventions.

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 1, 2026
• Study Start: April 15, 2026
• Primary Completion: May 24, 2026
• Study Completion: June 1, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within 6 months following publication of primary results. Data will remain available indefinitely through the institutional repository.
• 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

Locations

SY (1)