14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin

Not Applicable

Completed

• Conditions: Cumulative Irritation

• Registration Number: NCT02309294
• Lead Sponsor: Church & Dwight Company, Inc.

Brief Summary

The objective of this study is to determine the ability of the study material to cause irritation to the skin of humans under controlled patch test conditions. Substances that come into contact with human skin need to be evaluated for their propensity to irritate and/or sensitize. This testing is a modified primary irritancy patch test that can detect weak irritants that require multiple applications to cause a skin reaction.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2014-12-03
• Study First Submitted QC: 2014-12-04
• Study First Posted: 2014-12-05
• Results First Submitted: 2016-07-28
• Status Verified: 2016-10
• Results First Submitted QC: 2016-10-05
• Last Update Submitted: 2016-10-05
• Results First Posted: 2016-10-12
• Last Update Posted: 2016-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Are a male or female, 18 years of age or older, in general good health;
• Have normal skin;
• Are free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, will interfere with the study results or increase the risk of adverse events;
• Are of any skin type or race providing the skin pigmentation will allow discernment of erythema;
• Complete a medical screening procedure; and
• Read, understand, and sign an informed consent.

Exclusion Criteria

• Have any visible skin disease at the study site which, in the opinion of the investigative personnel, will interfere with the evaluation;
• Are receiving systematic or topical drugs or medication which, in the opinion of the investigative personnel, will interfere with the study results;
• Have psoriasis and/or active atopic dermatitis/eczema; and/or
• Have a known sensitivity to cosmetics, skin care products, or topical drugs as related to the material being evaluated.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Subjects That Showed no Significant Irritation	14 days	Score of less than or equal to 1.2 on the Cumulative Irritation Test scale (0-5).

Trial Locations

Locations (1)

TKL Research, Inc.; 🇺🇸 Fair Lawn, New Jersey, United States