Human Repeat Insult Patch Test to Evaluate Personal Lubricants
HRIPT
1 other identifier
interventional
222
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
April 14, 2016
CompletedResults Posted
Study results publicly available
September 1, 2017
CompletedApril 15, 2021
March 1, 2021
29 days
February 29, 2016
August 2, 2017
March 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Patients That Showed Sensitization Reaction to the Test Material at Challenge
24, 48 and 72 hours after patch application
Study Arms (1)
Healthy subject
EXPERIMENTALHealthy subjects exposed to "Chameleon" personal lubricant via occlusive patch
Interventions
Eligibility Criteria
You may qualify if:
- good health as determined from screener
- signed and dated informed consent
- signed and dated HIPAA Form
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Harrison Research Laboratories, Inc.
Union, New Jersey, 07083, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Annahita Ghassemi
- Organization
- Church & Dwight Co., Inc
Study Officials
- PRINCIPAL INVESTIGATOR
Lynne B Harrison, PhD
Harrison Research Laboratories, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- All participants receive the same interventions
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 29, 2016
First Posted
April 14, 2016
Study Start
February 1, 2016
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
April 15, 2021
Results First Posted
September 1, 2017
Record last verified: 2021-03