A clinical study to determine the skin safety and effectiveness of hair removal cream in Healthy Human Females
- Registration Number
- CTRI/2023/02/049825
- Lead Sponsor
- Dabur India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 35
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method