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

Not Applicable

Completed

• Conditions: Dermal Irritation
• Interventions: Device: Trojan "Chameleon" Personal Lubricant

• Registration Number: NCT02737618
• Lead Sponsor: Church & Dwight Company, Inc.

Brief Summary

to determine the ability of the test article to cause irritation to the skin of humans under controlled patch test conditions

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Study First Submitted: 2016-03-22
• Study First Submitted QC: 2016-04-11
• Study First Posted: 2016-04-14
• Status Verified: 2017-08
• Results First Submitted: 2017-08-02
• Results First Submitted QC: 2017-08-02
• Last Update Submitted: 2017-08-02
• Results First Posted: 2017-09-01
• Last Update Posted: 2017-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• male or female, 18-70 years of age, in general good health
• normal skin
• 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
• of any skin type or race providing the skin pigmentation will allow discernment of erythema
• agree to complete a medical history and concomitant medication form
• read, understand and sign 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 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
• have a known sensitivity to cosmetics, skin care test articles, or topical drugs as related to the test article being evaluated
• are females who are pregnant or breastfeeding or become pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy subject	Trojan "Chameleon" Personal Lubricant	Healthy subjects exposed to Trojan "Chameleon" Personal Lubricant applied by occlusive patch

Primary Outcome Measures

Name	Time	Method
Number of Subjects That Showed Erythema Based on 5 Point Scoring Scale	14 days
Number of Subjects That Showed Edema Based on the 5 Point Scoring Scale	14 days

Trial Locations

Locations (1)

TKL Research Inc; 🇺🇸 Fair Lawn, New Jersey, United States