Primary Irritation Patch Test on Healthy Adult Human Subjects with Normal Skin.

Not Applicable

Completed

• Registration Number: CTRI/2024/01/061088
• Lead Sponsor: Honasa Consumer Pvt. Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2024-01-17
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 26

Inclusion Criteria

1Males and non-pregnant or non-lactating females preferably equal numbers of males and females between age group of 18 to 65 years both inclusive at the time of consent.

2Participants with normal Fitzpatrick skin type three to five.

3Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application.

4Participants who do not have any previous history of adverse skin conditions and are not under any medication are likely to interfere with the results.

5Participants are in good general health as determined by the Investigator on the basis of medical history.

Exclusion Criteria

1Participants having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks e.g. tattoos, scars, sunburn, open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test sites i.e. back that can interfere with the reading.

2Participant with history of asthma or COPD Chronic obstructive pulmonary disease, diabetes and mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.

3Participant suffering from any active clinically significant skin diseases which may affect the study results.

4Participant having history of any skin diseases including eczema, atopic dermatitis.

5Participation in any patch test for irritation or sensitization within the last four weeks.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety assessment of productsTimepoint: 30 minutes of patch removal (Day 02), 24 hours (Day 03) and 168 hours (Day 09)

Secondary Outcome Measures

Name	Time	Method
ILTimepoint: NI