To check irritation potential of the given samples (Patch test)

Phase 2

Completed

Conditions: Skin patch test

Registration Number: CTRI/2013/04/003579

Lead Sponsor: ITC R and D CENTRE

Brief Summary: Skin Irritation Test:

Irritants are substances that damage the skin. The damage will depend upon the nature, concentration and duration of exposure. Irritation is manifested as inflammatory responses such as erythema (redness), Oedema (swelling), and vesiculation and finally to an intense suppurate reaction without the involvement of the immune system. The irritation potential of a substance can be assessed by human patch test.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 24

Inclusion Criteria

Is a female/ male in generally good health,Is between the ages of 18 and 50 years,Has not participated in a similar clinical investigation in the past four weeks,Is willing to give a written informed consent and come for regular observation.

Exclusion Criteria

A known history or present condition of allergic response to any cosmetic products,Skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations on the scalp), which would interfere with the test readings,Medications (e.g. steroids or antihistamines), which would compromise the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
irritation potential	On each subjectâ€™s back one patch of each investigational product will be applied on Day 1. This will be 9 days study. For all the products and positive control the subjects will be assessed by the study dermatologist on Day 1 (Day of patch application), Day 2 (0 hrs. of patch removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch removal).

Secondary Outcome Measures

Name	Time	Method
Investigational products to be tested for irritancy test	On each subjectâ€™s back one patch of each investigational product will be applied on Day 1. This will be 9 days study. For all the products and positive control the subjects will be assessed by the study dermatologist on Day 1 (Day of patch application), Day 2 (0 hrs. of patch removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch removal).

Trial Locations

Locations (1): The KETs Scientific research centre, Cosmetology division
🇮🇳
(Suburban), MAHARASHTRA, India
The KETs Scientific research centre, Cosmetology division
🇮🇳(Suburban), MAHARASHTRA, India
Ms Yamini Patil
Principal investigator
022-25639644
yamini@kelkarcosmetology.com