A safety and efficacy evaluation of a female intimate wash product

Not Applicable

Completed

• Registration Number: CTRI/2020/04/024457
• Lead Sponsor: ITC Life Sciences and Technology Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-10-24
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 35

Inclusion Criteria

1. Healthy women in the age group of 18- 55 years.

2. Atleast one instance of UTI in the past 6

months.

3. Women willing to abide by the study protocol

and study restrictions including abstinence from:

use of any other product besides the allotted

product during the study course, changing their usual brand of sanitary products and laundry detergents during the study course,showering/ bathing / cleaning their genitals with the test product on the day of study visit,depilation of pubic hair through topical products/waxing/ shaving (Trimming with scissors allowed)during the study course,oral or topical Anti-biotic/ Anti mycotic/Anti

inflammatory medicine or OTC / products without

informing to the study investigator.

Exclusion Criteria

1. Women who are pregnant or lactating

2. Women with a known history or present condition of allergic response to any cosmetic products/ fragranced product which may influence the study result.

3. Women with bacterial vaginosis/ candidiasis/

mycotic infections / active psoriasis/ eczema/

other active skin disorder / any form of chronic infection / allergy / disease which may influence the study result.

4. Women in the post menopausal age group

5. Women with vulvo-vaginal dryness

6. Women who are currently taking or had taken

antibiotics course in the past 3 months

7. Women who have changed the contraceptive

medications or Menopausal / Hormonal treatment in the past 3 months or are contemplating to do so.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of Feminine Intimate Wash productTimepoint: Day 0, Day 28

Secondary Outcome Measures

Name	Time	Method
Efficacy of the Feminine Intimate Wash productTimepoint: Day 0, Day 28