Human Repeat Insult Patch Test to Evaluate Personal Lubricants

Edema Clinical Trial

— HRIPT  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02737631
• Other study ID #: ST-7619
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: March 2016

Study information

• Verified date: March 2021
• Source: Church & Dwight Company, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Erythema

Intervention

Device:
• "Chameleon" Personal Lubricant

Locations

Country	Name	City	State
United States	Harrison Research Laboratories, Inc.	Union	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Church & Dwight Company, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients That Showed Sensitization Reaction to the Test Material at Challenge		24, 48 and 72 hours after patch application