Dry SkinDEPRONCT07618234
Dermocosmetic Evaluation of Propolis Ointments in Atopic-Prone Dry Skin
A study testing Ethanolic extract of propolis and Crude propolis in people with Dry Skin and Atopic Dermatitis, run by Manara University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dry Skin, Atopic Dermatitis, Xerosis Due to Atopic Dermatitis
- What is being tested?
- Ethanolic extract of propolis and Crude propolis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSyria
- Study dates
- 15 Apr 2026to 24 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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
Read the 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:
- EEP Ointment 3%: ethanolic extract of propolis (3%), white soft paraffin (67%), liquid paraffin (20%), anhydrous lanolin (10%)
- Crude Propolis Ointment 5%: micronized crude propolis (5%), white soft paraffin (65%), liquid paraffin (20%), anhydrous lanolin (10%)
- 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.
- Being tested
- Ethanolic extract of propolis, Crude propolis, Vehicle ointment
- Keywords
- propolis, apitherapy, dermocosmetic, skin barrier, natural product, corticosteroid-sparing, atopic dermatitis, xerosis, topical ointment, bee product
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethanolic extract of propolisOther
Also called EEP, Propolis extract, Bee propolis extract
3% ethanolic extract of propolis in ointment base
Crude propolisOther
Also called Raw propolis, Natural propolis, Micronized propolis, Bee glue
5% micronized crude propolis in ointment base
Vehicle ointmentOther
Also called Placebo ointment, Base ointment, Control ointment, White soft paraffin base
Ointment base without propolis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Vehicle ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0) and Week 4
Secondary outcomes (1)
Pruritus Visual Analog Scale (VAS)
Self-reported itching intensity on a 0-10 scale, where 0=no itching and 10=worst possible itching.
Measured: Baseline (Week 0), Week 2, and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start15 Apr 2026
- Primary completion24 May 2026
- Study completion24 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three parallel groups with no crossover between interventions.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chadi Khatib, Manara University
- Investigators
- Mahmoud Bitar, BPharm St., Study director, Manara UniversityHaya Farhat, BPharm St., Study director, Manara UniversityNagham Saleh, BPharm St., Study director, Manara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618234
- Sponsor's protocol ID
- SHAMNA-2026-027
- Other IDs
- SHAMNA-2026-027, MU-URO-260426-01
- Acronym
- DEPRO
- Status last verified
- Oct 2026
- First submitted
- 25 May 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07618234
- Acronym / sponsor ID
- DEPRO / SHAMNA-2026-027
- Keywords
- propolis, apitherapy, dermocosmetic, skin barrier, natural product, corticosteroid-sparing, atopic dermatitis, xerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Manara UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 24 May 2026 (actual)
- Study completion
- 24 May 2026 (actual)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- EEP Ointment 3%: ethanolic extract of propolis (3%), white soft paraffin (67%), liquid paraffin (20%), anhydrous lanolin (10%)
- Crude Propolis Ointment 5%: micronized crude propolis (5%), white soft paraffin (65%), liquid paraffin (20%), anhydrous lanolin (10%)
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Three parallel groups with no crossover between interventions.
| Arm | Type | Receives |
|---|---|---|
| EEP Ointment 3% | Experimental | Other: Ethanolic extract of propolisOintment containing 3% ethanolic extract of propolis, white soft paraffin 67%, liquid paraffin 20%, anhydrous lanolin 10%. Applied twice daily for 4 weeks. |
| Crude Propolis Ointment 5% | Experimental | Other: Crude propolisOintment containing 5% micronized crude propolis, white soft paraffin 65%, liquid paraffin 20%, anhydrous lanolin 10%. Applied twice daily for 4 weeks. |
| Vehicle Ointment | Placebo comparator | Other: Vehicle ointmentBase ointment containing white soft paraffin 70%, liquid paraffin 20%, anhydrous lanolin 10%. No propolis. Applied twice daily for 4 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ethanolic extract of propolisAlso: EEP, Propolis extract, Bee propolis extract3% ethanolic extract of propolis in ointment base | Other | EEP Ointment 3% |
| Crude propolisAlso: Raw propolis, Natural propolis, Micronized propolis, Bee glue5% micronized crude propolis in ointment base | Other | Crude Propolis Ointment 5% |
| Vehicle ointmentAlso: Placebo ointment, Base ointment, Control ointment, White soft paraffin baseOintment base without propolis | Other | Vehicle Ointment |
Primary outcome
Change in Clinical Dryness Score
Time frame: 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.
1 secondary outcome
Pruritus Visual Analog Scale (VAS)
Time frame: Baseline (Week 0), Week 2, and Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Bitar, BPharm St. study director
Manara University
Haya Farhat, BPharm St. study director
Manara University
Nagham Saleh, BPharm St. study director
Manara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethanolic extract of propolis and Crude propolis in people with Dry Skin and Atopic Dermatitis, run by Manara University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical Dryness Score (time frame: Baseline (Week 0) and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.