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

Church & Dwight

Status: Completed

Conditions: Cumulative Irritation

Treatments: Device: KY Liquid lubricant; Device: Novel lubricant Miami w/ fragrance; Device: Wet Platinum lubricant; Device: Novel lubricant Miami no fragrance; Device: Astroglide Gel lubricant

Study type: Interventional

Funder types: Industry

Identifiers

NCT02309294

ST-7553

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

43 participants in 1 patient group

Healthy Subject

Experimental group

Description:

Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).

Treatment:

Device: Wet Platinum lubricant

Device: Astroglide Gel lubricant

Device: Novel lubricant Miami no fragrance

Device: KY Liquid lubricant

Device: Novel lubricant Miami w/ fragrance