Human Repeat Insult Patch Test to Evaluate Personal Lubricants

Completed · Not applicable

Conditions studied: Erythema, Edema

In brief

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.

Key facts

Study ID

NCT02737631

Run by

Church & Dwight Company, Inc.

People needed

222

Starts

2016-02-01

Expected to finish

2016-03-01

Last updated by the study team

2021-04-15

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Harrison Research Laboratories, Inc. — Union, New Jersey, United States

Full record on ClinicalTrials.gov

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