A prospective, randomized, comparative open label study to evaluate efficacy and safety of Cysteamine 5% cream with Hydroquinone 4 % cream in patients with Melasma.
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Percent improvement in MSI score and mMASI score as assessed by a certified dermatologist.
研究概览
简要总结
This prospective, randomized, comparative, open label study is to compare efficacy, safety and tolerability of Cysteamine 5% cream with Hydroquinone 4% cream in melasma patients. After obtaining written informed consent, patients will be screened and eligible patients with melasma will be randomized into either Cysteamine 5% cream arm or Hydroquinone 4% cream arm. Study drug will be applied for 30 min for 112 days and comparator will be applied at bedtime.
Efficacy evaluations (MSI score, mMASI score) will be done at baseline, Day 14, Day 28, Day 56 and Day 112.
Safety will be assessed for any adverse or serious adverse events, patient reported symptoms and recorded by the treating physician and also if the physician deemed the event to be related to either study drug or comparator. Mexametry to determine melanin content of the skin will be done at Baseline, Day 56 and Day 112. Dermatological assessment for skin tolerability will be done in all visits along with MASI ,mMASI score will be determined at all visits. Quality of Life questionnaire to determine change in quality of lifestyle related to melasma and number of events will be obtained from patients at baseline, Day 56 and Day 112.
In the maintenance phase, patient will be followed up every two weeks telephonically up to 12 weeks or time of relapse, whichever is earlier. Patient complaining of relapse will be asked for physical examination at the site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who meet following criteria will be randomized in the study-
- •Indian adult subjects aged 18 to 60 years
- •Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory check-up)
- •With healthy intact skin on the studied anatomic unit (free of eczema, wounds, inflammation)
- •Patients willing to provide informed consent.
排除标准
- •Patients who do not meet following criteria will be randomized in the study-
- •Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
- •Having refused to give consent by not signing the consent form.
- •Taking part in another study liable to interfere with this study.
- •Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months)
- •Having progressive asthma.
- •Being epileptic.
- •Having non-stabilized thyroid disease (requirement of a stabilized treatment for at least 6 months)
- •Having cutaneous hypersensitivity to study ingredients
- •Having a diagnosed or highly probable allergy to one or several compounds of cosmetic products.
- •Following a chronic medical treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticosteroid therapy, taken by general or local routes (the only medication permitted is paracetamol).
结局指标
主要结局
Percent improvement in MSI score and mMASI score as assessed by a certified dermatologist.
时间窗: At day 0, 14, 28, 56 and 112 compared to baseline
次要结局
- 1. Percent reduction in melanin content of pigmentory spots (melasma) assessed through a spectrophotometer (mexameter) at day 0,14, 28, 56 and 112 compared to baseline.(2. Dermatological assessment score for cosmetic acceptability at day 0,14, 28, 56 and 112.)
研究者
Dr Wani Imran Majid
Cutis Institute of Dermatology