Human Repeat Insult Patch Test to Evaluate Personal Lubricants

Not Applicable

Completed

• Conditions: Edema; Erythema
• Interventions: Device: "Chameleon" Personal Lubricant

• Registration Number: NCT02737631
• Lead Sponsor: Church & Dwight Company, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-29
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Study First Submitted QC: 2016-04-11
• Study First Posted: 2016-04-14
• Results First Submitted: 2017-08-02
• Results First Submitted QC: 2017-08-02
• Results First Posted: 2017-09-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-24
• Last Update Posted: 2021-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy subject	"Chameleon" Personal Lubricant	Healthy subjects exposed to "Chameleon" personal lubricant via occlusive patch

Primary Outcome Measures

Name	Time	Method
Number of Patients That Showed Sensitization Reaction to the Test Material at Challenge	24, 48 and 72 hours after patch application

Trial Locations

Locations (1)

Harrison Research Laboratories, Inc.; 🇺🇸 Union, New Jersey, United States