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

Church & Dwight Company, Inc.43 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Cumulative Irritation

Interventions

Novel lubricant Miami w/ fragranceDEVICE

0.2 ml aliquot on occlusive patch

Novel lubricant Miami no fragranceDEVICE

0.2 ml aliquot on occlusive patch

KY Liquid lubricantDEVICE

0.2 ml aliquot on occlusive patch

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

TKL Research, Inc.

Fair Lawn, New Jersey, United States

Outcomes

Primary Outcomes

Number of Subjects That Showed no Significant Irritation

Score of less than or equal to 1.2 on the Cumulative Irritation Test scale (0-5).

Time frame: 14 days

Data from ClinicalTrials.gov

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