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Clinical Trials/CTRI/2013/12/004191
CTRI/2013/12/004191CompletedNot Applicable

Cumulative Irritancy Study (12 Days)

Johnson Johnson1 site in 1 country30 target enrollmentStarted: October 10, 2013Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Determination of Cumulative irritation potential of the test product by predictive patch test technique
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Study Synopsis:-

-The objective of this study is to determine the cumulative irritation potential of the  test materials by patch test.

-This is a controlled, single center study. Each test material will be applied every day for the 12 days (12 applications).

-patches will be applied for approximately a 24 hour period & then graded.

-25 normal healthy subjects will be enrolled in the study. Additional 5 subjects will be recruited to compensate for dropouts and incidence of irritation to patch material if any.

-The duration of the study is approximately 2 weeks.

Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Not Applicable

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

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 and the use of tanning beds 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.
  • •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 within the next six (6) months 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 have had less than a two week rest period since completion of any previous patch testing.
  • •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.
  • •Individuals with active hepatitis.
  • •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.

Outcomes

Primary Outcomes

Determination of Cumulative irritation potential of the test product by predictive patch test technique

Time Frame: 12 days evaluation continuously

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Johnson Johnson
Sponsor Class
Other [fmcg]

Study Sites (1)

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