A Clinical Study to Evaluate the Efficacy of Tatshan After Sun recovery Gel in Reducing Erythma and Inflammation after UV-B Exposure on skin
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in Erythema with Mexameter
研究概览
简要总结
To Evaluate the efficacy of a gel containing extract of phormidium persinicum , glyceryl glucoside ,beta glycirhettinic acid , natural alpha bisobolol in reducing erythema after UVB exposure.
To evaluate its utility in treatment of sunburns
Day0: MED at three spots. send the volunteers with the test creams. ask them to apply the said creams twice a day for 7 days . as the volunteers to apply
patch 1 test cream twice a day
patch 2 Calamine and liquid paraffin lotion twice a day
patch 3 Aloevera Gel twice a day
Patch 4 Blank
Day 2: once the redness is visible - measure redness with colorimeter , pigment - Mexameter, edema by Dermat, temperature - dedicated skin temperature probe- Pain- questionnaire, Imaging Day 3: a followup call for redness, pain Day 7: Same as Day 2 assessments
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Having apparently healthy skin on test area, for whom the investigator considers that the compliance will be correct and who can allow irradiation slightly more than the MED.
- •Cooperating, informed of the need and duration of the examinations and ready to comply with protocol procedures.
- •Having signed a Consent form.
- •Should be able to read and write (in English, Hindi or local language).
- •Having valid proof of identity and age.
排除标准
- •Pregnant or nursing mothers 2.Scars, excessive terminal hair or tattoo on the studied area 3.Henna tattoo anywhere on the body (in case of studies involving hair dyes) 4.Dermatological infection or pathology on the level of studied area 5.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye) 6.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures 7.Chronic illness which may influence the outcome of the study 8.Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month) 9.Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial.
结局指标
主要结局
Change in Erythema with Mexameter
时间窗: Day 2, Day 7
次要结局
- Change in redness with colorimeter(Day 2, Day 7)
- Change in Edema by Dermat(Day 2, Day 7)
- Change in skin Temperature(Day 2, Day 7)
研究者
Dr Robin Chugh
CCFT Laboratories