Cumulative Irritation Test

Phase 1

Completed

• Conditions: Onychomycosis
• Interventions: Drug: AN2690; Other: AN2690 Solution, Vehicle; Other: Sodium Lauryl Sulfate, 0.5%

• Registration Number: NCT00680095
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2007-01-22
• Primary Completion: 2007-02-19
• Study Completion: 2007-02-19
• Study First Submitted: 2008-05-15
• Study First Submitted QC: 2008-05-15
• Study First Posted: 2008-05-19
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-05
• Last Update Posted: 2019-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	AN2690	AN2690 Solution, 2.5%
B	AN2690	AN2690 Solution, 7.5%
C	AN2690	AN2690 Solution, 5.0%
D	AN2690 Solution, Vehicle	AN2690 Solution, Vehicle
E	Sodium Lauryl Sulfate, 0.5%	Sodium Lauryl Sulfate, 0.5%

Primary Outcome Measures

Name	Time	Method
Severe irritation (Grade 3 or 4) observed at any site	Daily for 21 days

Trial Locations

Locations (1)

The Education and Research Foundation, Inc.; 🇺🇸 Lynchburg, Virginia, United States