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Cumulative Irritation Test

Primary Purpose

Onychomycosis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

AN2690

AN2690 Solution, Vehicle

Sodium Lauryl Sulfate, 0.5%

About this trial

This is an interventional other trial for Onychomycosis focused on measuring Onychomycosis, Fungal Nail

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

The Education and Research Foundation, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

AN2690 Solution, 2.5%

AN2690 Solution, 7.5%

AN2690 Solution, 5.0%

AN2690 Solution, Vehicle

Sodium Lauryl Sulfate, 0.5%

Outcomes

Primary Outcome Measures

Severe irritation (Grade 3 or 4) observed at any site

Secondary Outcome Measures

Full Information

NCT ID

NCT00680095

First Posted

May 15, 2008

Last Updated

April 5, 2019

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00680095

Brief Title

Cumulative Irritation Test

Official Title

21-day Cumulative Irritation Test

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

January 22, 2007 (Actual)

Primary Completion Date

February 19, 2007 (Actual)

Study Completion Date

February 19, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Onychomycosis

Keywords

Onychomycosis, Fungal Nail

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Masking

None (Open Label)

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

AN2690 Solution, 2.5%

Arm Title

Arm Type

Experimental

Arm Description

AN2690 Solution, 7.5%

Arm Title

Arm Type

Experimental

Arm Description

AN2690 Solution, 5.0%

Arm Title

Arm Type

Active Comparator

Arm Description

AN2690 Solution, Vehicle

Arm Title

Arm Type

Active Comparator

Arm Description

Sodium Lauryl Sulfate, 0.5%

Intervention Type

Drug

Intervention Name(s)

AN2690

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

AN2690

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

AN2690

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

AN2690 Solution, Vehicle

Intervention Description

AN2690 Solution, Vehicle, Daily for up to 21 days

Intervention Type

Other

Intervention Name(s)

Sodium Lauryl Sulfate, 0.5%

Intervention Description

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

Primary Outcome Measure Information:

Title

Severe irritation (Grade 3 or 4) observed at any site

Time Frame

Daily for 21 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

The Education and Research Foundation, Inc.

City

Lynchburg

State/Province

Virginia

ZIP/Postal Code

24501

Country

United States

12. IPD Sharing Statement

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Cumulative Irritation Test

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