CTRI/2013/07/003822已完成4 期
An open label, single centered study to evaluate the efficacy of a cosmetic/ayurvedic formulation in the treatment of Miliaria (Prickly Heat) on affected children subjects.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- To ascertain the efficacy of the investigational product in reducing the miliaria.
研究概览
简要总结
This is an open label, single centered clinicalstudy. There will be only children (male and female) volunteers in thestudy. Total 30 + 5 subjects will be enrolled in the study. This will be a 5days study. All the subjects will be assessed on Baseline, day 3 and day 5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
入排标准
- 年龄范围
- 5.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Volunteer in generally good health.
- •2.Volunteer between the ages of 05 to 12 years.
- •3.Volunteer with primary miliaria.
- •4.Volunteer has not participated in a similar clinical investigation in the past four weeks.
- •5.Volunteer willing to abstain from using any cosmetic/medical product on the test site during the entire study course.
- •6.Volunteer willing to visit the site on scheduled visit.
- •7.Volunteer willing to give a sign a written assent form and come for regular observation.
排除标准
- •1.A known history or present condition of allergic response to any cosmetic products.
- •2.Skin disease except Miliaria (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations), which would interfere with the test readings.
- •3.Medications (e.g. steroids or antihistamines), which would compromise the study.
- •4.Currently or has been undergoing dermatologist treatments or procedures within the last 1 month.
- •5.Volunteer viewed by the investigator as not being able to complete the study or participating in another study.
结局指标
主要结局
To ascertain the efficacy of the investigational product in reducing the miliaria.
时间窗: Baseline (day 1), day 3 and day 5.
次要结局
- Reducing irritation(Baseline (day 1), day 3 and day 5.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study of the Metabolic Profile of Dalcetrapib in Healthy VolunteersHealthy VolunteerNCT01476267Hoffmann-La Roche6
Unknown
2 期
The Efficacy of Intravenous Immunoglobulin Therapy for Severe 2019-nCoV Infected Pneumonia2019-nCoVNCT04261426Peking Union Medical College Hospital80
进行中（未招募）
早期 1 期
A Preliminary Exploratory Study to Evaluate the Safety and Immunogenicity of Omicron Variant Bivalent Vaccine V-01-B5COVID-19 PandemicNCT05585567Livzon Pharmaceutical Group Inc.48
尚未招募
1 期
A Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of VRT106 in Combination With Chemotherapy for Advanced Pancreatic CancerPancreatic CancerNCT06866977Xiangya Hospital of Central South University10
招募中
2 期
Radiotherapy Combined With Fluzopanib and Abiraterone Acetate Tablets (II) Treatment for mCRPCNCT06971211Jianbin Bi40