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

2026년 5월 25일 업데이트: 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

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

30

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
다른: Ethanolic extract of propolis
3% ethanolic extract of propolis in ointment base
다른 이름들:
  • EEP
  • Propolis extract
  • Bee propolis extract
실험적: 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.
다른: Crude propolis
5% micronized crude propolis in ointment base
다른 이름들:
  • 꿀벌 접착제
  • Raw propolis
  • Natural propolis
  • Micronized propolis
위약 비교기: Vehicle Ointment
Base ointment containing white soft paraffin 70%, liquid paraffin 20%, anhydrous lanolin 10%. No propolis. Applied twice daily for 4 weeks.
다른: Vehicle ointment
Ointment base without propolis
다른 이름들:
  • 위약 연고
  • Base ointment
  • Control ointment
  • White soft paraffin base

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Clinical Dryness Score
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Pruritus Visual Analog Scale (VAS)
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Skin Comfort Assessment
기간: 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
기간: 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
기간: Week 4
Overall satisfaction with treatment using a Likert scale (1=Very dissatisfied, 5=Very satisfied).
Week 4
Standardized Clinical Photography
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Manara University

수사관

  • 연구 책임자: Mahmoud Bitar, BPharm St., Manara University
  • 연구 책임자: Haya Farhat, BPharm St., Manara University
  • 연구 책임자: Nagham Saleh, BPharm St., Manara University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 4월 15일

기본 완료 (실제)

2026년 5월 24일

연구 완료 (추정된)

2026년 6월 1일

연구 등록 날짜

최초 제출

2026년 5월 25일

QC 기준을 충족하는 최초 제출

2026년 5월 25일

처음 게시됨 (실제)

2026년 6월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 25일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • SHAMNA-2026-027 (레지스트리 식별자: Syrian Scientific Society for Medicinal Herbs (SHAMNA))
  • MU-URO-260426-01 (기타 식별자: Manara University)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

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

IPD 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • ANALYTIC_CODE
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다