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Human Repeat Insult Patch Test to Evaluate Personal Lubricants (HRIPT)

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ClinicalTrials.gov Identifier: NCT02737631
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:
The purpose of this test is to evaluate the sensitizing potential of a personal lubricant, as a result of repeated occlusive patch. The intervention will be applied for a total of 9 induction applications, followed by an approximately 2 week rest period, then followed by a 24-72 hour Challenge applications.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: All participants receive the same interventions
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 via occlusive patch
Device: Trojan "Chameleon" Personal Lubricant



Primary Outcome Measures :
  1. Number of Patients That Showed Erythema Based on the 5 Point Scoring Scale [ Time Frame: 8 weeks ]
  2. Number of Patients That Showed Edema Based on the 5 Point Scoring Scale [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • good health as determined from screener
  • signed and dated informed consent
  • signed and dated HIPAA Form

Exclusion Criteria:

  • subjects on test at any other research laboratory or clinic
  • known allergy or sensitivity to cosmetics and toiletries, including sunscreens, adhesives and/or topical drugs
  • pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study
  • pre-existing other medical conditions (e.g. adult asthma, diabetes).
  • treatment with antibiotics, antihistamines or corticosteroids within two weeks prior to initiation of the test
  • chronic medication which could affect the results of the study (e.g., insulin, corticosteroids, antihistimines, steroidal or non-steroidal anti-inflammatory drugs [except for therapeutic maintenance dosage of aspirin], antibiotics, steroid inhalers, etc.)
  • known pregnant or nursing women

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): NCT02737631


Locations
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United States, New Jersey
Harrison Research Laboratories, Inc.
Union, New Jersey, United States, 07083
Sponsors and Collaborators
Church & Dwight Company, Inc.
Investigators
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Principal Investigator: Lynne B Harrison, PhD Harrison Research Laboratories, Inc.

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Responsible Party: Church & Dwight Company, Inc.
ClinicalTrials.gov Identifier: NCT02737631     History of Changes
Other Study ID Numbers: ST-7619
First Posted: April 14, 2016    Key Record Dates
Results First Posted: September 1, 2017
Last Update Posted: September 1, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Erythema
Skin Diseases
Skin Manifestations
Signs and Symptoms