Dermocosmetic Evaluation of Propolis Ointments in Atopic-Prone Dry Skin (DEPRO)
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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Latakia、シリア
- Manara University, Faculty of Pharmacy
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
3% ethanolic extract of propolis in ointment base
他の名前：
|
|
実験的：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.
|
5% micronized crude propolis in ointment base
他の名前：
|
|
プラセボコンパレーター：Vehicle Ointment
Base ointment containing white soft paraffin 70%, liquid paraffin 20%, anhydrous lanolin 10%.
No propolis.
Applied twice daily for 4 weeks.
|
Ointment base without propolis
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Clinical Dryness Score
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pruritus Visual Analog Scale (VAS)
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Skin Comfort Assessment
時間枠：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
時間枠：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
時間枠：Week 4
|
Overall satisfaction with treatment using a Likert scale (1=Very dissatisfied, 5=Very satisfied).
|
Week 4
|
|
Standardized Clinical Photography
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Mahmoud Bitar, BPharm St.、Manara University
- スタディディレクター：Haya Farhat, BPharm St.、Manara University
- スタディディレクター：Nagham Saleh, BPharm St.、Manara University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- SHAMNA-2026-027 (レジストリ識別子：Syrian Scientific Society for Medicinal Herbs (SHAMNA))
- MU-URO-260426-01 (その他の識別子：Manara University)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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