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

NCT ID: NCT02737618

Last Updated: 2017-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-03-31

Brief Summary

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

Conditions

Dermal Irritation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Healthy subject

Healthy subjects exposed to Trojan "Chameleon" Personal Lubricant applied by occlusive patch

Group Type: EXPERIMENTAL

Trojan "Chameleon" Personal Lubricant

Intervention Type: DEVICE

silicone base with sensate

Interventions

Trojan "Chameleon" Personal Lubricant

silicone base with sensate

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Church & Dwight Company, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Dosik, MD

Role: PRINCIPAL_INVESTIGATOR

TKL Research, Inc.

Locations

TKL Research Inc

Fair Lawn, New Jersey, United States

Countries

United States

Other Identifiers

ST-7611

Identifier Type: -

Identifier Source: org_study_id