CTRI/2023/02/049825已完成未知
A Two Arm, Two Test Products, Randomized, Evaluator Blinded, Safety, Efficacy and In-Use Tolerability Study of Hair Removal Cream (HRC) in Healthy Human Females
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1)Age: 18 to 55 years (both inclusive) old at the time of consent.
- •2)Sex: Healthy human non-pregnant/non-lactating females
- •3)Frequent user of hair removal cream
- •4)Females who wax or shave a minimum 1-2 times a month.
- •5)Females of childbearing potential must have a self-reported negative urine pregnancy test on Day 01 before application & agree to follow an accepted method of birth control for the duration of the study such as condoms, foams, jellies, diaphragm, intrauterine device etc.
- •6)Subjects are generally in good general health as determined from recent medical history.
- •7)The subject does not have any previous history of adverse skin conditions and is not under any medication likely to interfere with the results.
- •8)The subjects who have not waxed or used hair removal cream in the past 1 month or more and who frequently use hair removal cream.
- •9)The subject is willing and able to follow the study directions, participate in the study, returning for all specified visits.
- •10)The subject must be able to understand and provide written informed consent to participate in the study.
排除标准
- •1)Subject with known allergy or sensitization to any of the product ingredients in the test product.
- •2)The subject with very fine hair or very slow growth.
- •3)The subject has skin irritation, open wounds, cuts, abrasions, irritation symptoms or any on application sites.
- •4)The subject has skin irritation, blemishes, moles, pigmentation, pimples, marks [e.g. tattoos (within the previous 3 months), scars, sunburn], open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) i.e. back that can interfere with the reading.
- •5)Medication which may affect skin response and/or past medical history.
- •6)The subject has a history of diabetes.
- •7)The subject has a history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
- •8)The subject suffering from any active clinically significant skin diseases which may contraindicate.
- •9)The subject has a history of any skin diseases including eczema, atopic dermatitis or active cancer.
- •10)The subject has a history of asthma or COPD (Chronic obstructive pulmonary disease).
- •11)Topical drugs used at the application site.
- •12)Subject with Self-reported Immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematosus.
- •13)An individual who has a medical condition or is taking or has taken a medication which, in the Investigatorâ??s judgment, makes the subject ineligible or places the subject at undue risk.
- •14)Participation in other clinical studies simultaneously.
研究者
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