To assess the efficacy of hair removing cream on healthy human subjects.

Phase 2/3

Completed

• Conditions: healthy female subjects

• Registration Number: CTRI/2017/12/010907
• Lead Sponsor: Dabur India Ltd

Brief Summary

Study was designed to test the safety & efficacy of topical products provided by Dabur India Limited on healthy human subjects. 24 female subjects were enrolled in the study, and 23 completed the study. The study was conducted over a period of approximately 60 days for each subject. the test product was patched on the arms of the subject  . The skin was evaluated for signs of irritation identified under Erythema and odema, using Draize’s scale.

After patch removal, the sample test product applied on skin was applied for 3-6 minutes and observation taken by dermatologist, self subject observation and instrument test on corneometer, hair analyzer , Mexameter and chromometer .  Post product removal, observation taken for immediate reactions and 30 days & 60 days post removal for delayed reactions.

All the test products were deemed to be dermatologically safe as per their classification into non­ irritant category at all time points of evaluation. The hair was removed within the time range of 3-6 minutes by test products and skin fairness, glow improves.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-22
• Study Completion: 2012-05-19
• Last Update Posted: 2019-11-02

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

• 1.Subjects in generally good health 2.Subjects in the age group of 18-35 years.
• 3.Subjects with moderate hair growth on lower outer forearms.
• 4.Subjects without any cuts, marks and open wounds on lower outer forearms.
• 5.Subject has not participated in a similar investigation in the past four weeks.
• 6.Subjects have not used a similar product for the last four weeks.
• 7.Subjects willing to give a written informed consent and come for regular follow up.

Exclusion Criteria

• 1.Subjects with known allergies or sensitivities to cosmetic products, toiletries or its components like fragrances, preservatives,hydroquinone, vitamin C, Niacin amide,retinol, soy etc.
• 2.Currently or has been using topical retinoids, alpha-hydroxy and/or beta-hydroxy acids,hydroquinone or any whitening/Fairness preparation in any form (cleanser, toner, cream or soaps) within the last 1 month.
• 3.Currently or has been undergoing dermatologist skin treatments or procedures within the last 1 month.
• 4.Currently or has been involved in another skin care clinical investigation within the last 3 months.
• 5.Subjects who have pre-existing or dormant dermatologic conditions (e.g., psoriasis, rosacea, rashes, eczema, many and/or severe excoriations etc.) that could interfere with the outcome of the study as determined by the investigator.
• 6.Subjects with scars which could interfere with expert grader and/or instrumental evaluations.
• 7.Subjects who are nursing as determined by the investigator interview during screening or pregnant as determined by the Urine pregnancy testing after screening.
• 8.Subjects viewed by the investigator as not being able to complete the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of hair removing cream and skin darkening effect on Repetitive usage on healthy human subjects	Day 1, Day 30 and Day 60

Secondary Outcome Measures

Name	Time	Method
safety of the subject throughout the study	Day 1, Day 30 and Day 60

Trial Locations

Locations (1)

Kelkar Education Trust, Scientific Research Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

Kelkar Education Trust, Scientific Research Centre

🇮🇳Mumbai, MAHARASHTRA, India

Uma Ayachit

Principal investigator

022-25639644

uma@kelkarcosmetology.com