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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All study personnel including the statistician are blinded. An independent pharmacist prepares coded packages.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究者
Chadi Khatib
Principal Investigator
Manara University