HRIPT: Human Repeat Insult Patch Test to Evaluate Personal Lubricants
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.
Study Design
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
- Number of Patients That Showed Sensitization Reaction to the Test Material at Challenge [24, 48 and 72 hours after patch application]
Eligibility Criteria
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
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.- ST-7619
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
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
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 |
annahita.ghassemi@churchdwight.com |
- ST-7619