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

25 mei 2026 bijgewerkt door: Chadi Khatib, Manara University

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

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

30

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: Ethanolic extract of propolis
3% ethanolic extract of propolis in ointment base
Andere namen:
  • Eep
  • Propolis extract
  • Bee propolis extract
Experimenteel: 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.
Ander: Crude propolis
5% micronized crude propolis in ointment base
Andere namen:
  • Bijen lijm
  • Raw propolis
  • Natural propolis
  • Micronized propolis
Placebo-vergelijker: Vehicle Ointment
Base ointment containing white soft paraffin 70%, liquid paraffin 20%, anhydrous lanolin 10%. No propolis. Applied twice daily for 4 weeks.
Ander: Vehicle ointment
Ointment base without propolis
Andere namen:
  • Placebo zalf
  • Base ointment
  • Control ointment
  • White soft paraffin base

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Clinical Dryness Score
Tijdsspanne: 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.
Baseline (Week 0) and Week 4

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pruritus Visual Analog Scale (VAS)
Tijdsspanne: Baseline (Week 0), Week 2, and Week 4
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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Skin Comfort Assessment
Tijdsspanne: Baseline (Week 0), Week 2, and Week 4
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
Tijdsspanne: Week 2 and Week 4
Self-reported assessment of ointment spreadability, greasiness, absorption, texture, and ease of application.
Week 2 and Week 4
Subject Satisfaction Score
Tijdsspanne: Week 4
Overall satisfaction with treatment using a Likert scale (1=Very dissatisfied, 5=Very satisfied).
Week 4
Standardized Clinical Photography
Tijdsspanne: Baseline (Week 0) and Week 4
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Manara University

Onderzoekers

  • Studie directeur: Mahmoud Bitar, BPharm St., Manara University
  • Studie directeur: Haya Farhat, BPharm St., Manara University
  • Studie directeur: Nagham Saleh, BPharm St., Manara University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 april 2026

Primaire voltooiing (Werkelijk)

24 mei 2026

Studie voltooiing (Geschat)

1 juni 2026

Studieregistratiedata

Eerst ingediend

25 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

25 mei 2026

Eerst geplaatst (Werkelijk)

1 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

25 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SHAMNA-2026-027 (Register-ID: Syrian Scientific Society for Medicinal Herbs (SHAMNA))
  • MU-URO-260426-01 (Andere identificatie: Manara University)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

Within 6 months following publication of primary results. Data will remain available indefinitely through the institutional repository.

IPD-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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