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

NCT ID: NCT02309294

Last Updated: 2016-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2014-12-31

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.

Conditions

Cumulative Irritation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Healthy Subject

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).

Group Type: EXPERIMENTAL

Novel lubricant Miami w/ fragrance

Intervention Type: DEVICE

0.2 ml aliquot on occlusive patch

Novel lubricant Miami no fragrance

Intervention Type: DEVICE

0.2 ml aliquot on occlusive patch

KY Liquid lubricant

Intervention Type: DEVICE

0.2 ml aliquot on occlusive patch

Astroglide Gel lubricant

Intervention Type: DEVICE

0.2 ml aliquot on occlusive patch

Wet Platinum lubricant

Intervention Type: DEVICE

0.2 ml aliquot on occlusive patch

Interventions

Novel lubricant Miami w/ fragrance

0.2 ml aliquot on occlusive patch

Intervention Type: DEVICE

Novel lubricant Miami no fragrance

0.2 ml aliquot on occlusive patch

Intervention Type: DEVICE

KY Liquid lubricant

0.2 ml aliquot on occlusive patch

Intervention Type: DEVICE

Astroglide Gel lubricant

0.2 ml aliquot on occlusive patch

Intervention Type: DEVICE

Wet Platinum lubricant

0.2 ml aliquot on occlusive patch

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Church & Dwight Company, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

TKL Research, Inc.

Fair Lawn, New Jersey, United States

Countries

United States

Other Identifiers

ST-7553

Identifier Type: -

Identifier Source: org_study_id