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

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 Overview

• Status: Completed
• Conditions: Cumulative Irritation
• Intervention / Treatment: Device: Novel lubricant Miami w/ fragrance; Device: Novel lubricant Miami no fragrance; Device: KY Liquid lubricant; Device: Astroglide Gel lubricant; Device: Wet Platinum lubricant

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Fair Lawn, New Jersey, United States, 07410
      • TKL Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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).	Device: Novel lubricant Miami w/ fragrance; 0.2 ml aliquot on occlusive patch; Device: Novel lubricant Miami no fragrance; 0.2 ml aliquot on occlusive patch; Device: KY Liquid lubricant; 0.2 ml aliquot on occlusive patch; Device: Astroglide Gel lubricant; 0.2 ml aliquot on occlusive patch; Device: Wet Platinum lubricant; 0.2 ml aliquot on occlusive patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	14 days

Collaborators and Investigators

• Sponsor: Church & Dwight Company, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: December 3, 2014
• First Submitted That Met QC Criteria: December 4, 2014
• First Posted (ESTIMATE): December 5, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): October 12, 2016
• Last Update Submitted That Met QC Criteria: October 5, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Patch Test
• Other Study ID Numbers: ST-7553