CTRI/2024/02/062599尚未招募Unknown
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 Frequent Users of Hair Removal Cream. - NI
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
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 and non-lactating females.
- •3) Frequent user of hair removal cream.
- •4) Females who wax or shave 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 use hair removal cream in past 1 month 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 product ingredients.
- •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 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 or systemic lupus erythematosus.
- •13) An individual who has a medical condition or is taking or has taken a medication which, in the Investigator’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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