Safety Testing of cosmetic product by Patch test

Completed

Conditions: Adult healthy subjects (Male and Female) in the age group of 18 years to 45 years (both inclusive) will be selected

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

Sample Size: Twenty four (male and female, in a nearly equal ratio of 1:1) adult subjects in the age group of 18 years to 45 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 (BIS4011:2018)

Recruitment & Eligibility

Inclusion Criteria

Healthy male and female subjects in the age group of 18-45 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 a history of excessive sweating 5.
Subjects on an oral corticosteroid, or using any topical or systemic medicine which might interfere with the study results 6.
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.

Primary Outcome Measures

Name	Time	Method
Safety assessment of investigational products for	Safety assessment of investigational products for irritation potential using draize scale.
irritation potential using Draize scale at 0 hour, 24 hours and 7 days post patch removal.	Safety assessment of investigational products for irritation potential using draize scale.

Secondary Outcome Measures

Name	Time	Method
Not Applicable	Not Applicable

Locations (1): Auriga Research Private Limited
🇮🇳
Gurgaon, HARYANA, India
Auriga Research Private Limited
🇮🇳Gurgaon, HARYANA, India
Dr Urvi Panchal
Principal investigator
9540930950
drurvi77@gmail.com