Oral Isotretinoin in The Treatment of Melasma A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Response to treatment
研究概览
简要总结
Melasma is a common refractory acquired hyperpigmentation of the skin having a serious impact on patients' quality of life. Melasma is challenging to treat. Treatment is often a multimodality approach. Due to the attached psychological and social stress, it is important to counsel patients with melasma adequately about the chronicity of the disease, the importance of photoprotection, and the role of hormones in disease persistence before embarking on therapeutic correction. So in this study, we are exploring the efficacy of oral isotretinoin for treating melasma.
详细描述
Melasma has a significant impact on the quality of life and self-esteem of those affected. Darker skin photo types e.g. Egyptians have excess potential to develop melasma.
Melasma is a chronic and challenging condition to manage. Previous treatment modalities have been unsatisfactory.
Oral isotretinoin is a potential treatment modality for melasma that has not been investigated yet.
In this study we aim to evaluate the efficacy and the tolerability of oral isotretinoin in the treatment of melasma and to compare its efficacy and tolerability with the current gold standard "topical triple combination formula"
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 50 years
- •Patients complaining of melasma.
- •Patients with all types of melasma (epidermal, dermal and mixed)
- •Sexually active women who is willing to follow at least 2 types of contraceptive methods during study period
- •Patients with skin type I-V
排除标准
- •Pregnant or nursing women.
- •Women on any concurrent therapy for melasma.
- •Patients that are using any therapy for melasma for the last 45 days.
- •Patient with abnormal liver function test or lipid profile.
- •Patients with allergy or hypersensitivity to the assigned drugs.
- •Women not willing to follow contraceptive methods at time of study.
- •Patients on facial treatments or photosensitizing drugs within previous 6 months.
- •Patients with back or joint pain.
- •Patients with pre-existing or dormant dermatologic disease on the face that could interfere with the outcome of the study
研究组 & 干预措施
Isotretinoin
patients will receive oral isotretinoin (1 mg/kg/day) for 3 months
干预措施: Isotretinoin (Drug)
Kligman Formula arm
patients will receive topical triple combination formula at night everyday over the affected areas for 3 months
干预措施: Triple combination formula (Drug)
结局指标
主要结局
Response to treatment
时间窗: three months
Treatment efficacy will be assessed by the change in disease severity measured in mMASI at the end of the treatment period, and the difference in the global appearance of melasma through standardized photographs using Global Aesthetic Improvement Scale (GAIS) using a five-point ordinal scale (1 = exceptionally improved appearance, 2 = very improved appearance, 3 = improved appearance, 4 = unaltered appearance, 5 = worsened appearance). The duration taken till complete clearance will be assessed as well.
Time to complete clearance
时间窗: 12 weeks
The duration taken till complete clearance will be assessed as well.
次要结局
- Treatment tolerability(12 weeks)
- Quality of life index(12 weeks)
研究者
Hagar Nofal
Lecturer of Dermatology
Zagazig University