HRIPT: Human Repeat Insult Patch Test to Evaluate Personal Lubricants

Sponsor
Church & Dwight Company, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02737631
Collaborator
(none)
222
1
1
29
233

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: "Chameleon" Personal Lubricant
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
222 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
All participants receive the same interventions
Primary Purpose:
Screening
Study Start Date :
Feb 1, 2016
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Healthy subject

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

Device: "Chameleon" Personal Lubricant

Outcome Measures

Primary Outcome Measures

  1. Number of Patients That Showed Sensitization Reaction to the Test Material at Challenge [24, 48 and 72 hours after patch application]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 69 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Harrison Research Laboratories, Inc. Union New Jersey United States 07083

Sponsors and Collaborators

  • Church & Dwight Company, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Church & Dwight Company, Inc.
ClinicalTrials.gov Identifier:
NCT02737631
Other Study ID Numbers:
  • ST-7619
First Posted:
Apr 14, 2016
Last Update Posted:
Apr 15, 2021
Last Verified:
Mar 1, 2021
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Healthy Subject
Arm/Group Description Healthy subjects exposed to Trojan "Chameleon" personal lubricant via occlusive patch Trojan "Chameleon" Personal Lubricant
Period Title: Overall Study
STARTED 222
COMPLETED 222
NOT COMPLETED 0

Baseline Characteristics

Arm/Group Title Healthy Subject
Arm/Group Description Healthy subjects exposed to Trojan "Chameleon" personal lubricant via occlusive patch Trojan "Chameleon" Personal Lubricant
Overall Participants 222
Age, Customized (Count of Participants)
18-69 years
222
100%
Sex: Female, Male (Count of Participants)
Female
150
67.6%
Male
72
32.4%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome
Title Number of Patients That Showed Sensitization Reaction to the Test Material at Challenge
Description
Time Frame 24, 48 and 72 hours after patch application

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Subject
Arm/Group Description Healthy subjects exposed to "Chameleon" personal lubricant via occlusive patch "Chameleon" Personal Lubricant
Measure Participants 222
Count of Participants [Participants]
0
0%

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group Title Healthy Subject
Arm/Group Description Healthy subjects exposed to Trojan "Chameleon" personal lubricant via occlusive patch Trojan "Chameleon" Personal Lubricant
All Cause Mortality
Healthy Subject
Affected / at Risk (%) # Events
Total / (NaN)
Serious Adverse Events
Healthy Subject
Affected / at Risk (%) # Events
Total 0/222 (0%)
Other (Not Including Serious) Adverse Events
Healthy Subject
Affected / at Risk (%) # Events
Total 0/222 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Confidentiality agreement in place with PIs.

Results Point of Contact

Name/Title Annahita Ghassemi
Organization Church & Dwight Co., Inc
Phone 6098061200
Email annahita.ghassemi@churchdwight.com
Responsible Party:
Church & Dwight Company, Inc.
ClinicalTrials.gov Identifier:
NCT02737631
Other Study ID Numbers:
  • ST-7619
First Posted:
Apr 14, 2016
Last Update Posted:
Apr 15, 2021
Last Verified:
Mar 1, 2021