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

August 2, 2017 updated by: Church & Dwight Company, Inc.
to determine the ability of the test article to cause irritation to the skin of humans under controlled patch test conditions

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Subjects That Showed Erythema Based on 5 Point Scoring Scale
Time Frame: 14 days
14 days
Number of Subjects That Showed Edema Based on the 5 Point Scoring Scale
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Church & Dwight Company, Inc.

Investigators

  • Principal Investigator: John Dosik, MD, TKL Research, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

March 22, 2016

First Submitted That Met QC Criteria

April 11, 2016

First Posted (Estimate)

April 14, 2016

Study Record Updates

Last Update Posted (Actual)

September 1, 2017

Last Update Submitted That Met QC Criteria

August 2, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • ST-7611

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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