Repeated Insult Patch Test of Personal Lubricants

Not Applicable

Completed

• Conditions: Edema; Erythema
• Interventions: Device: KY Liquid lubricant; Device: Astroglide Gel lubricant

• Registration Number: NCT02297841
• Lead Sponsor: Church & Dwight Company, Inc.

Brief Summary

Determine the ability of the study material (personal lubricant) to cause sensitization by repeated topical application to the skin of humans under controlled patch test conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-17
• Study First Submitted QC: 2014-11-19
• Study First Posted: 2014-11-21
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2016-07-19
• Status Verified: 2016-09
• Results First Submitted QC: 2016-09-14
• Last Update Submitted: 2016-09-14
• Results First Posted: 2016-10-05
• Last Update Posted: 2016-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

Inclusion Criteria

• In general good health
• 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
• Read, understand, and sign an informed consent agreement

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 systemic 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.
• Are females who are pregnant, planning on getting pregnant during the study, or breast-feeding
• Have a known sensitivity for cosmetics, skin care products, topical drugs, or any other type of the products, as related to the material being evaluated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Human Repeat Insult Patch Test	KY Liquid lubricant	Approximately 0.2ml of each intervention (Experimental: Novel lubricant Miami Fragrance, Experimental: Novel lubricant Miami no Fragrance, KY Liquid lubricant, Astroglide Gel lubricant) was applied to an occlusive patch and applied to participant's back.
Human Repeat Insult Patch Test	Astroglide Gel lubricant	Approximately 0.2ml of each intervention (Experimental: Novel lubricant Miami Fragrance, Experimental: Novel lubricant Miami no Fragrance, KY Liquid lubricant, Astroglide Gel lubricant) was applied to an occlusive patch and applied to participant's back.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events as a Measure of Safety and Tolerability	24, 48, and 72 hours after patch application