Formulation of Retinyl Palmitate-loaded Topical Ethosomes for Treatment of Acne Vulgaris: a Split-face Comparative Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Efficacy of the medication: number of inflammatory, non-inflammatory and total lesions
研究概览
简要总结
Acne is a chronic inflammatory dermatosis of the pilosebaceous unit. Topical treatment is the first choice in mild and moderate cases of acne, especially topical retinoids. Although topical retinoids are very effective in the treatment of acne, local cutaneous irritation including burning, itching, erythema, peeling or dryness, is observed in a considerable number of patients, resulting in low patient compliance, compromising the efficacy of the therapy.
Several approaches have been proposed to address these concerns, including the use of esters of retinoic acid (RA) and RA precursors, such as retinol and retinaldehyde, or novel drug delivery systems, which present the potential for controlled release, in turn reducing the aforementioned occurrences.
Encapsulation of retinoids into vesicular carriers as liposomes and ethosomes and nanoparticulate carriers can significantly improve their effects for the treatment of acne compared with commercial formulations , providing better tolerability of irritating retinoid.
The aim of work is to assess the efficacy and tolerability of the topical application of Retinyl Palmitate-loaded ethosome formulation in the treatment of acne vulgaris in comparison to conventional formulation of classic retinoids
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The topical preparations are packed in non-identifiable jars and coded by a person who is not involved in the study the patient.
入排标准
- 年龄范围
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with facial mild to moderate acne vulgaris
- •Patients aged 12-40 years old
排除标准
- •Pregnant females
- •Patients with skin condition of the face such as rosacea, perioral dermatitis, atopic or seborrheic dermatitis or psoriasis.
- •Patients with known hypersensitivity to preparations containing retinoid.
- •Patients who take any other cocomitant systemic or topical medications for acne vulgaris
研究组 & 干预措施
retinyl palmitate ethosomes arm
All patients will be instructed to apply a thin film of the new formula on one side of the face
干预措施: retinyl palmitate (Drug)
tretinoin arm
All patients will be instructed to apply a thin film of topical retinoid cream on the other side of the face
干预措施: Tretinoin (Drug)
结局指标
主要结局
Efficacy of the medication: number of inflammatory, non-inflammatory and total lesions
时间窗: at first and every 2 weeks during the 6-week treatment period from starting the topical application
counting the number of inflammatory, non-inflammatory and total lesions at first and every week during the treatment
assessment of tolerability: interviewing the patients
时间窗: every 2 weeks during the 6-week treatment period from starting the topical application
interviewing the patients about any sign/symptom of adverse reactions (erythema, peeling, burning sensation, dryness and pruritus)
次要结局
未报告次要终点
研究者
Sara Mohamed Awad
Assistant Professor
Assiut University