Clinical Evaluation of efficacy and safety of Antiseptic Cream in mild to moderate skin cuts, scratches, chapping and dryness
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. Change in healing of minor cuts, wounds, scratches, chapped skin, lips, and cracked heels
研究概览
简要总结
It is a clinical study to evaluate efficacy and safety of Antiseptic Cream in mild to moderate skin cuts, scratches, chapping and dryness. The study will be carried out at one center in India. Subjects will be asked to apply Emami Antiseptic cream on skin cuts, scratches, chapping and dryness twice daily for a period of 30 days. The primary objectives will be to assess change in healing of minor cuts, wounds, scratches, chapped skin, lips, and cracked heels, and number of days require for healing of minor cuts, wounds, scratches, chapped skin, lips, and cracked heels. The secondary objectives will be to assess change in skin cutaneous moisturization, change in overall skin texture/roughness (Tactile) and (Visual), change in overall skin desquamation, change in softness in chapped skin and lips, change in skin softness and glow, skin patch test using Dermal Response Score, global assessment for overall change and adverse events/adverse drug reactions including vitals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with cuts, scratches on skin and dryness of skin
- •Willing to comply with all requirements of the study.
排除标准
- •1.Subjects with a known current history of chronic skin diseases or autoimmune diseases, such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo and rosacea
- •Subjects with a tattoo, a scar, moles, too many hairs or anything on the Right leg which might interfere with the evaluation.
- •Subjects with intensive exposure to sunlight or UV-rays within the previous month and foreseen during the study.
- •Subjects who have used facial blemish-lightening products, topical or oral whitening drugs.
- •Moisturizing cream, lotion or oil within 21 days before entering the trial
- •Subjects on any other investigational products within 1 month prior to randomization
- •Subjects with known current tuberculosis, HIV, ischemic heart disease, cancer, kidney failure, liver failure
- •Pregnant and lactating women
- •Known hypersensitivity to any of the ingredients of Emami Antiseptic Cream
- •Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the study.
结局指标
主要结局
1. Change in healing of minor cuts, wounds, scratches, chapped skin, lips, and cracked heels
时间窗: Baseline visit (day 0), day 15 and end of study visit (Day 30)
2. Number of days require for healing of minor cuts, wounds, scratches, chapped skin, lips, and cracked heels
时间窗: Baseline visit (day 0), day 15 and end of study visit (Day 30)
次要结局
- 1. Change in skin cutaneous moisturization(2. Change in overall skin texture/roughness (Tactile) and (Visual))
研究者
Dr Amruta Bhagwan More
Target Institute of Medical Education and Research Pvt Ltd.