Human Repeat Insult Patch Test to Evaluate Personal Lubricants

NCT ID: NCT02737631

Last Updated: 2021-04-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-03-31

Brief Summary

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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

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Conditions

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Erythema Edema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

All participants receive the same interventions

Study Groups

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Healthy subject

Healthy subjects exposed to "Chameleon" personal lubricant via occlusive patch

Group Type EXPERIMENTAL

"Chameleon" Personal Lubricant

Intervention Type DEVICE

Interventions

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"Chameleon" Personal Lubricant

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Church & Dwight Company, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lynne B Harrison, PhD

Role: PRINCIPAL_INVESTIGATOR

Harrison Research Laboratories, Inc.

Locations

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Harrison Research Laboratories, Inc.

Union, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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ST-7619

Identifier Type: -

Identifier Source: org_study_id

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