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

Primary Purpose

Erythema, Edema

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
"Chameleon" Personal Lubricant
Sponsored by
Church & Dwight Company, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Erythema

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Harrison Research Laboratories, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy subject

Arm Description

Healthy subjects exposed to "Chameleon" personal lubricant via occlusive patch

Outcomes

Primary Outcome Measures

Number of Patients That Showed Sensitization Reaction to the Test Material at Challenge

Secondary Outcome Measures

Full Information

First Posted
February 29, 2016
Last Updated
March 24, 2021
Sponsor
Church & Dwight Company, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02737631
Brief Title
Human Repeat Insult Patch Test to Evaluate Personal Lubricants
Acronym
HRIPT
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Church & Dwight Company, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythema, Edema

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
All participants receive the same interventions
Allocation
N/A
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy subject
Arm Type
Experimental
Arm Description
Healthy subjects exposed to "Chameleon" personal lubricant via occlusive patch
Intervention Type
Device
Intervention Name(s)
"Chameleon" Personal Lubricant
Primary Outcome Measure Information:
Title
Number of Patients That Showed Sensitization Reaction to the Test Material at Challenge
Time Frame
24, 48 and 72 hours after patch application

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynne B Harrison, PhD
Organizational Affiliation
Harrison Research Laboratories, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harrison Research Laboratories, Inc.
City
Union
State/Province
New Jersey
ZIP/Postal Code
07083
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Human Repeat Insult Patch Test to Evaluate Personal Lubricants

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