A clinical study to determine the skin safety and effectiveness of hair removal cream in Healthy Human Females

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2023
INTERVENTION: Intervention1: Hair Removal Cream: First application on‐site: HRC used on one arm, razor used on other for hair removal. Second application: at home. Control Intervention1: Hair Removal Razor: First application on‐site: HRC used on one arm, razor used on other for hair removal. Second application: at home CONDITION: PRIMARY OUTCOME: To evaluate the effectiveness of the test product for following parameters ; a)Change in Skin color and skin tone ; b)Change in skin hydration ; c)Change in skin texture‐smoothness and roughness ; d)Hair re‐growth, double hair from one follicle ; e)Visual evaluation for redness, irritation, itching, burning sensationTimepoint: From baseline before application to Day 01 after product removal, Day 2, day 3, day 7 and day 28 SECONDARY OUTCOME: To evaluate the effectiveness of test product on subjective parameters (sensorial and product perception) using hedonic scoring scale.Timepoint: From baseline before application to Day 01 after product removal, Day 2, day 3, day 7 and day 28 INCLUSION CRITERIA: 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 wa Xor 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 ab
Epistemonikos ID: 9693b981ada97ced7118563ad9aff57f50afd309
First added on: Feb 20, 2024