Prospective, randomized multi-centre, study to compare the effectiveness, safety and tolerability of Lulican shampoo versus ketoconazole shampoo, in Indian adult patients with mild to moderate scalp Seborrheic Dermatitis (LEAD Study).
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 3
- 主要终点
- Reduction in Seborrheic Dermatitis Severity Score in both the groups at the end of 4 weeks treatment.
研究概览
简要总结
This prospective, open label, randomized clinical trial has been planned in order to compare the effectiveness, safety and tolerability of Lulican (Luliconazole 1%+ Salicylic acid 3% + ZPTO 1%) vs. ketoconazole (ketoconazole 2%+ZPTO 1%) shampoo in Indian adult patients with mild to moderate scalp seborrheic dermatitis.
Eligible patients will be enrolled in the study. The decision to prescribe shampoo, will be made by the treating physician based on prescribing information as per clinical judgement.
Treatment will be self-applied thrice weekly for 4 weeks.
The patients will be randomized into two groups (A and B). Patients of group A will be prescribed Lulican shampoo while patients of group B will be prescribed 1% ketoconazole shampoo.
All patients will apply shampoo 3 times a week for 4 weeks. Patient will be advised to visit after 2 days of head wash.
Effectiveness will be assessed at week 2 and end of treatment and will be compared to parameters recorded at baseline.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients (18-65 yrs) diagnosed with scalp seborrheic dermatitis and candidates for shampoo therapy at the discretion by treating physician
- •Willing to use shampoo thrice a week as advised
- •Willing to avoid oil application for study duration
- •Patients willing to refrain from other forms of treatment including other topical, oral medication for seborrheic dermatitis
- •Patients who are willing to appear for regular follow ups and follow the prescribed treatment regularly
- •Patients who are willing to give consent to participate in the study.
排除标准
- •Pregnant/ Planning to conceive/ Lactating women
- •Immunocompromised patients on corticosteroids, other immunosuppressive or biologic drugs
- •Patients suffering from infectious, auto-immune, or other disorders affecting skin of scalp.
- •Documented and known history of severe systemic disease, necessitating medical treatment, as assessed by the investigator that might interfere with the conduct of the study or the interpretation of results.
- •Patients known to be allergic to the any of the components of the study medications.
- •Use of any topical medication including OTC products for dandruff within 14 days of enrolment.
- •Patients who are receiving drugs which are known to affect scalp or hair.
- •Patients with known malignancy.
- •Refusal to participate in the study.
结局指标
主要结局
Reduction in Seborrheic Dermatitis Severity Score in both the groups at the end of 4 weeks treatment.
时间窗: Time frame – at end 4 weeks
次要结局
- 1. Evaluation of tolerability and cosmetic acceptability at the end of study(2. Number of participants with any Adverse Event (AE) in both the groups)