Cumulative Irritation Test

NCT ID: NCT00680095

Last Updated: 2019-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-22

Study Completion Date

2007-02-19

Brief Summary

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The purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor.

Detailed Description

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Healthy, adult volunteers of either sex will be patched on his/her back with AN2690 Solution 2.5%, AN2690 Solution 5%, AN2690 Solution 7.5%, AN2690 Solution Vehicle and Sodium Laurel Sulfate 0.5% over the course of 21 consecutive days. After 24 hours, the patches are to be removed and the site evaluated using a five-point scale for irritation.

Conditions

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Onychomycosis

Study Design

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Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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A

AN2690 Solution, 2.5%

Group Type EXPERIMENTAL

AN2690

Intervention Type DRUG

AN2690 Solution, 2.5%, Daily for up to 21 days

B

AN2690 Solution, 7.5%

Group Type EXPERIMENTAL

AN2690

Intervention Type DRUG

AN2690 Solution, 7.5%, Daily for up to 21 days

C

AN2690 Solution, 5.0%

Group Type EXPERIMENTAL

AN2690

Intervention Type DRUG

AN2690 Solution, 5.0%, Daily for up to 21 days

D

AN2690 Solution, Vehicle

Group Type ACTIVE_COMPARATOR

AN2690 Solution, Vehicle

Intervention Type OTHER

AN2690 Solution, Vehicle, Daily for up to 21 days

E

Sodium Lauryl Sulfate, 0.5%

Group Type ACTIVE_COMPARATOR

Sodium Lauryl Sulfate, 0.5%

Intervention Type OTHER

Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days

Interventions

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AN2690

AN2690 Solution, 2.5%, Daily for up to 21 days

Intervention Type DRUG

AN2690

AN2690 Solution, 7.5%, Daily for up to 21 days

Intervention Type DRUG

AN2690

AN2690 Solution, 5.0%, Daily for up to 21 days

Intervention Type DRUG

AN2690 Solution, Vehicle

AN2690 Solution, Vehicle, Daily for up to 21 days

Intervention Type OTHER

Sodium Lauryl Sulfate, 0.5%

Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy, volunteers of either sex, at least 18 years of age or older
* Females of childbearing potential submitted to a urine pregnancy test and had negative results at Day 1 and at the final visit and also was using an effective method of birth control (e.g. abstinence, implants, injectables, oral contraceptives, intrauterine contraceptive devices or double barrier) or agreed to use an effective method of birth control prior to becoming sexual active
* Subjects were of any skin type or race providing their degree of pigmentation did not interfere with making readings of skin reactions
* Subjects were willing to follow the study procedures and complete the study
* Written informed consent was obtained

Exclusion Criteria

* Subject with any skin disease that would have in any way confounded interpretation of the study results. Atopic dermatitis/eczema, psoriasis or chronic asthma were excluded
* Subject was pregnant or nursing
* Subject had a history of sensitivity to any component of any of the formulations
* Use of chronic medications (such as antihistamines, corticosteroids, analgesics and anti-inflammatories) for one week before and during the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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The Education and Research Foundation, Inc.

Lynchburg, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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C3371011

Identifier Type: OTHER

Identifier Source: secondary_id

AN2690-ONYC-101

Identifier Type: -

Identifier Source: org_study_id

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