A randomized clinical trial evaluating the efficacy and safety of Jesners solution against 88% Phenol: In the treatment of Alopecia Areata.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- 1.To assess the safety and therapeutic efficacy of 12 weeks regimen of administration of investigational products in adult Alopecia areata
研究概览
简要总结
Alopecia areata is common dermatological condition causing non-scarring hair loss affecting the quality of life and self-esteem. The treatment of alopecia areata remains challenging. Various modalities of treatment are available and most of the therapies used for the treatment of alopecia areata causes variety of side effect. Thus, quest for safer methods of treatment continues. Till date, there is no universally accepted therapy for the treatment of alopecia areata. Success of peeling agents like Phenol and Jessner’s solution helps in inducing hair growth in alopecia areata subjects that can be explained on the basis of release of growth factors and cytokines that are capable of antagonizing the peribulbar inflammatory infiltrate. Another proposed mechanism is through immunodulation causing destruction of hyperactive T cells mediated by local sensitizers. The present study is proposed to evaluate the efficacy and safety of Jessener solution against 88% phenol in the treatment of Alopecia Areata.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.who has not received any treatment during previous 2 months before commencing of the study.
- •2.Patients with minimum of two patches; ranging in circumference between 3cm to 10 cm.
- •3.Patients with patchy patches of stable AA over the scalp 4.Patients willing to be part of the study after informed consent.
排除标准
- •1.Patients treated with any other topical agent or immunosuppressive drugs.
- •2.Patients with scarring alopecia and scalp condition affecting the outcomes.
- •3.Patients who were on any allopathic or homeopathic treatment.
- •4.Patients with psychiatric medications and unrealistic expectations.
- •5.Pregnant and lactating mothers.
- •6.Patients with a history of keloid and hypertrophic scars.
- •7.Patient with any systemic disease (Cardiac, Renal, Hepatic, HIV, etc).
- •8.Patient with history of drug abuse.
- •9.Patient with collagen vascular disorder and auto-immune.
- •10.Patients with alopecia totalis and universalis.
- •11.Unwilling patients.
- •12.Other causes of alopecia like Androgenic alopecia, Diffuse telogen effluvium.
结局指标
主要结局
1.To assess the safety and therapeutic efficacy of 12 weeks regimen of administration of investigational products in adult Alopecia areata
时间窗: Baseline,4 weeks,8weeks and 12weeks
2.Treatment frequency
时间窗: Baseline,4 weeks,8weeks and 12weeks
次要结局
- 1. Assessment of hair growth from baseline using digital photography and Dermoscopy or Trichoscopy.(2.Time for regrowth)
研究者
Dr Rakesh Tilak Raj
Government Medical College