An interventional study of Ethanolic extract of propolis and Crude propolis in Dry Skin, Atopic Dermatitis and Xerosis Due to Atopic Dermatitis, sponsored by Manara University. Completed at 1 site in Syria. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Manara University · Not applicable, Interventional, and Other
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
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:
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:
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.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's enrollment of 30 is below the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →This is the only study on the registry with Manara University as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Base ointment containing white soft paraffin 70%, liquid paraffin 20%, anhydrous lanolin 10%. No propolis. Applied twice daily for 4 weeks.
Other: Vehicle ointment
3% ethanolic extract of propolis in ointment base
Also known as: EEP, Propolis extract, Bee propolis extract
5% micronized crude propolis in ointment base
Also known as: Raw propolis, Natural propolis, Micronized propolis, Bee glue
Ointment base without propolis
Also known as: Placebo ointment, Base ointment, Control ointment, White soft paraffin base
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.
Time frame: Baseline (Week 0) and Week 4
Pruritus Visual Analog Scale (VAS)
Self-reported itching intensity on a 0-10 scale, where 0=no itching and 10=worst possible itching.
Time frame: Baseline (Week 0), Week 2, and Week 4
Skin Comfort Assessment
Self-reported assessment of skin tightness, burning, soothing sensation, and softness using a Likert scale (1=Very uncomfortable, 5=Very comfortable).
Time frame: Baseline (Week 0), Week 2, and Week 4
Cosmetic Acceptability
Self-reported assessment of ointment spreadability, greasiness, absorption, texture, and ease of application.
Time frame: Week 2 and Week 4
Subject Satisfaction Score
Overall satisfaction with treatment using a Likert scale (1=Very dissatisfied, 5=Very satisfied).
Time frame: 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.
Time frame: Baseline (Week 0) and Week 4
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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