Skin sensitivity test to evaluate sensitization of test products-Repeat insult patch test.

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 210

Inclusion Criteria

Male or female subjects 18 to 65 years of age of Indian Race.
Subjects must be generally in good health as determined from a recent medical history which is on file with the investigator.
The ability of the subject to understand and sign a written informed consent form which must be obtained prior to treatment.
Willingness to avoid the use of topical products at the test sites during the study.
Willingness to avoid direct sun exposure to the test sites for the duration of the study.

Exclusion Criteria

Individuals with active or history of psoriasis, active allergic skin responses, or active eczema as determined by the initial paperwork.
Individuals with a history of eczema will be allowed on the study, as long as they complete a supplemental consent form.
Individuals with sunburn, acne, abrasions, scar tissue, or tattoos on the test sites, or diseases of the skin that might interfere with the evaluation made in this study or that expose study participants to unacceptable risks.
Women known to be pregnant, nursing, or planning to become pregnant during the study as determined by the initial paperwork.
Use of topical steroids and/or drugs at test sites as determined by the initial paperwork.
Current routine or frequent use of high doses of anti-inflammatory drugs for a defined medical condition as determined by the initial paperwork.
Aspirin use should not exceed two tablets (650 mg) daily.
Individuals who had less than a two week rest period since completion of any previous patch testing.
Individuals with uncontrolled metabolic diseases such as hypertension, hyperthyroidism, hypothyroidism, diabetes, etc.
Individuals who had a mastectomy in which axillary nodes were removed as determined by the initial paperwork.
Individuals currently receiving any anticancer, immunosuppressive treatments/medications, and/or radiation as determined by the initial paperwork.
Active or untreated skin cancer as determined by the initial paperwork.
Previous clinically determined allergic reaction on a patch study, or known sensitivities or allergies to personal care products of any type.
Individuals will be admitted to the study at the discretion of the Investigator based on medical history and findings of the pre-study interview and examination.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of sensitization potential of the test products by standard HRIPT method.	evaluation on each application visit (14 visits)

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): MS Clinical Research Pvt Ltd
🇮🇳
Bangalore, KARNATAKA, India
MS Clinical Research Pvt Ltd
🇮🇳Bangalore, KARNATAKA, India
Dr Mukesh Ramnane
Principal investigator
08040917253
mukesh.ramnane@mscr.in