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

Phase 2

Completed

• Conditions: skin patch test

• Registration Number: CTRI/2018/02/011785
• Lead Sponsor: ITC Limited Peenya Industrial Area Peenya Bangalore

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

Study Timeline

• Study Start: 2013-05-08
• Study Completion: 2013-08-13
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

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

Inclusion Criteria

• 1.Volunteer (female/ male) in generally good health.
• 2.Volunteer between the ages of 18 and 50 years.
• 3.Volunteer has not participated in a similar clinical investigation in the past four weeks.
• 4.Volunteer willing to give a written informed consent and come for regular observation.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
irritation potential	first observation will be made at 30 minutes of patch removal (0 hr. observation). The further observations will be at 24 hrs and 1 week of patch removal

Secondary Outcome Measures

Name	Time	Method
investigational products to be tested for irritancy test	On each subject’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)

KETs Scientific Research Centre; 🇮🇳 (Suburban), MAHARASHTRA, India

KETs Scientific Research Centre

🇮🇳(Suburban), MAHARASHTRA, India

Ms Vaishali Dhavan

Principal investigator

02225639644

vaishali@kelkarcosmetology.com