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

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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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
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

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




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 ]


Information from the National Library of Medicine

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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

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
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United States, New Jersey
TKL Research Inc
Fair Lawn, New Jersey, United States, 07410
Sponsors and Collaborators
Church & Dwight Company, Inc.
Investigators
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Principal Investigator: John Dosik, MD TKL Research, Inc.

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Responsible Party: Church & Dwight Company, Inc.
ClinicalTrials.gov Identifier: NCT02737618     History of Changes
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

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No