Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02737618
Recruitment Status : Completed
First Posted : April 14, 2016
Results First Posted : September 1, 2017
Last Update Posted : September 1, 2017
Sponsor:
Information provided by (Responsible Party):
Church & Dwight Company, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
to determine the ability of the test article to cause irritation to the skin of humans under controlled patch test conditions

Condition or disease Intervention/treatment Phase
Dermal Irritation Device: Trojan "Chameleon" Personal Lubricant Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Study Start Date : February 2016
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Healthy subject
Healthy subjects exposed to Trojan "Chameleon" Personal Lubricant applied by occlusive patch
 Device: Trojan "Chameleon" Personal Lubricant
silicone base with sensate


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of Subjects That Showed Erythema Based on 5 Point Scoring Scale [ Time Frame: 14 days ]
  2. Number of Subjects That Showed Edema Based on the 5 Point Scoring Scale [ Time Frame: 14 days ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737618


Locations
Layout table for location information
United States, New Jersey
TKL Research Inc
Fair Lawn, New Jersey, United States, 07410
Sponsors and Collaborators
Church & Dwight Company, Inc.
Investigators
Layout table for investigator information
Principal Investigator: John Dosik, MD TKL Research, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Church & Dwight Company, Inc.
ClinicalTrials.gov Identifier: NCT02737618    
Other Study ID Numbers: ST-7611
First Posted: April 14, 2016    Key Record Dates
Results First Posted: September 1, 2017
Last Update Posted: September 1, 2017
Last Verified: August 2017

Layout table for additional information
Studies a U.S. FDA-regulated Device Product: Yes