An Enhanced Transcutaneous Delivery of Topical Betamethasone for the Treatment of Vitiligo Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Physician's global assessment (PGA) scale
研究概览
简要总结
Vitiligo is the commonest acquired depigmenting disorder characterized by loss of melanocytes from the basal layer of skin causing white patches which leads to great psychological distress in many patients. Even though the pathogenic mechanisms of the loss of melanocytes are well researched, a permanent cure for the disease is still elusive. The key principle in the management of vitiligo is to attain stability and to induce active residual melanocytes to repopulate within the depigmented patch thus resulting in repigmentation. In recent years the use of various devices for enhanced transcutaneous delivery of various topical preparations has become more and more common in Dermatology. The aim of this study is to see whether using the Tixel device to enhance the penetration of topical betamethasone can improve the effectiveness of the treatment of pigment regeneration in vitiligo.
详细描述
Vitiligo is a psychologically devastating disorder. The fact that it typically occurs in exposed areas (the face and hands) has a major impact on self-esteem and perception of self. While lesions are usually asymptomatic, the psychosocial impact on patients can be tremendous.
Currently available medical therapies for vitiligo are unsatisfactory and there is no FDA approved drug for the treatment of vitiligo. The perfect medication for this disease would be a topically applied formulation that can rapidly restore pigmentation without systemic absorption or cutaneous side effects.
Tixel is a novel non-laser thermo-mechanical system (Tixel, Novoxel, and Israel), that is, a registered medical device in several countries worldwide. The mechanism of action is by evaporation and thermal decomposition of stratum corneum and the dehydration of epidermis.
The aim of our study is to evaluate the clinical effectiveness and safety profile of a novel approach using an energy-based device (Tixel, Novoxel, and Israel), followed by the topical application of Bethametasone for the treatment of vitiligo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Physician's global assessment (PGA) scale
时间窗: up to 2 years
0-4 scale of improvement 0- Absent: 0% 1. Minimal: \< 25% 2. Mild: 26-50% 3. Moderate: 51-75% 4 -Marked to complete: \> 75%.
Patient's global impression of change (PGIC) scale
时间窗: up to 2 years
The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. Although widely used in chronic pain clinical trials, PGIC's validity has not been formally assessed. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "1- very much improved," "2- much improved," "3- minimally improved," "4-no change," "5- minimally worse," "6- much worse," or "7- very much worse."
Dermatology life quality index (DLQI)
时间窗: up to 2 years
The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. There are 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment. Each question refers to the impact of the skin disease on the patient's life over the previous week Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). A series of validated "band descriptors" were described in 2005 to give meaning to the scores of the DLQI. These bands are as follows: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect.
次要结局
未报告次要终点
研究者
Eli Sprecher, MD
MD, PhD, MBA
Tel-Aviv Sourasky Medical Center