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

March 24, 2021 updated by: Church & Dwight Company, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

222

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
      • Union, New Jersey, United States, 07083
        • Harrison Research Laboratories, 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 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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 "Chameleon" personal lubricant via occlusive patch
Device: "Chameleon" Personal Lubricant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Patients That Showed Sensitization Reaction to the Test Material at Challenge
Time Frame: 24, 48 and 72 hours after patch application
24, 48 and 72 hours after patch application

Collaborators and Investigators

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

Sponsor

Church & Dwight Company, Inc.

Investigators

  • Principal Investigator: Lynne B Harrison, PhD, Harrison Research Laboratories, 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

February 29, 2016

First Submitted That Met QC Criteria

April 11, 2016

First Posted (Estimate)

April 14, 2016

Study Record Updates

Last Update Posted (Actual)

April 15, 2021

Last Update Submitted That Met QC Criteria

March 24, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST-7619

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.

Clinical Trials on Edema

Clinical Trials on "Chameleon" Personal Lubricant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe