Patch Test Study for Safety Testing of Cosmetics

Completed

• Conditions: Adult subjects in the age group of 18 years to 55 years (both inclusive) will be selected

• Registration Number: CTRI/2017/06/008742
• Lead Sponsor: ITC Life Sciences Technology Centre

Brief Summary

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|Objective :The objective of this study is to evaluate the dermatological safety of the investigational products on healthy human subjects.Primary irritation patch test is used widely for the evaluation of safety of cosmetics in humans.

Sample Size :Twenty four (male and female, in a ratio of 1:1) adult subjects in the age group of 18 years to 55 years (both inclusive)

Primary skin irritation results from reversible inflammatory changes in the skin following the application of a test substance.

By this test, irritation potential of a substance is assessed by a single application of patch under complete occlusion for 24 hrs and is done as per BIS standard (IS4011:1997)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-22
• Study Completion: 2017-05-30
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

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

Inclusion Criteria

• Healthy male and female subjects in the age group of 18-55 years (both age inclusive) 2.
• Subjects with Fitzpatrick skin type III to V 3.
• Subjects willing to give a voluntary written informed consent 4.
• Subjects having not participated in a similar investigation in the past two weeks 6.
• Subjects willing to come for regular follow up visits 7.
• Subjects without any open wounds, cuts, abrasions, irritation symptoms.

Exclusion Criteria

• Subjects with Infection/ allergy/ irritation symptoms on the upper back area identified for patch application 2.
• Subjects with any kind of skin allergy, antecedents or atopy or cutaneous disease which may influence the study results 3.
• Subject is Pregnant or Lactating 4.
• Athletes and subjects with history of excessive sweating 5.
• Subjects participating in any other cosmetic or therapeutic trial 7.
• Subjects with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety assessment of investigational products for irritation potential using Draize scale.	Draize scoring to be done at 0 hr, 24 hr and day 7 of patch removal

Secondary Outcome Measures

Name	Time	Method
N/A	N/A

Trial Locations

Locations (1)

CIDP Biotech India Pvt. Ltd.; 🇮🇳 Delhi, DELHI, India

CIDP Biotech India Pvt. Ltd.

🇮🇳Delhi, DELHI, India

Dr Preksha Singh MD

Principal investigator

08130531935

p.singh@cidp-cro.com