MedPath

Evaluation of Safety & Efficacy of Bath Accessories

Phase 1
Completed
Registration Number
CTRI/2018/03/012306
Lead Sponsor
ITC Life Sciences Technology Centre
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
24
Inclusion Criteria

1.Male and female volunteers in the age group of 18 to 50 years.

2.A total of 48 Male and 24 Female subjects.

3.Nearly equal representation of all skin typesââ?¬â?? Normal, Dry, Oily, Combination, Sensitive skin.

4.Female Volunteers who are neither pregnant nor nursing.

5.Volunteers having experienced a liquid bathing product in the past 6 months.

6.Volunteers who are willing to abstain from using any product other than the provided test products during the study period.

7.Volunteers willing to give a written informed consent.

Exclusion Criteria

1.Volunteers with an active skin disorder or a significant history of skin disorders (e.g. psoriasis, eczema, vitiligo, pityriasis versicolor, acne) which in the opinion of the Principle Investigator or Dermatologistmay affect the test results.

2.Volunteers whose skin has been excessively exposed to Sun or UV rays during the previous month in the opinion of the Investigator.

3.Volunteers with a known history or current condition of allergy or sensitivity to cosmetic products/fragrances.

4.Volunteers on undergoing any medical treatment or taking any systemic medicines since or taking steroids or antihistamines or medicines for chronic medical conditions or applying any topical medication that could compromise the study.

5.Female volunteers who are currently pregnant or breastfeeding.

6.Volunteers participating in any other cosmetics or any other clinical trial

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Dermatological safety of the test products in comparison to baseline with regular usage of the test product with no significant skin irritation.Timepoint: 14 days for each subject
Secondary Outcome Measures
NameTimeMethod
Efficacy of the investigational products in comparison to baseline in terms of improvement of skin condition with no significant skin reactions. <br/ ><br>Timepoint: 14 days for each subject
© Copyright 2025. All Rights Reserved by MedPath