Cumulative Irritation Test

Onychomycosis Clinical Trial

Official title:

21-day Cumulative Irritation Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00680095
• Other study ID #: AN2690-ONYC-101
• Secondary ID: C3371011
• Status: Completed
• Phase: Phase 1
• Start date: January 22, 2007
• Est. completion date: February 19, 2007

Study information

• Verified date: April 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: February 19, 2007
• Est. primary completion date: February 19, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Drug:
• AN2690
AN2690 Solution, 2.5%, Daily for up to 21 days
• AN2690
AN2690 Solution, 7.5%, Daily for up to 21 days
• AN2690
AN2690 Solution, 5.0%, Daily for up to 21 days

Other:
• AN2690 Solution, Vehicle
AN2690 Solution, Vehicle, Daily for up to 21 days
• Sodium Lauryl Sulfate, 0.5%
Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days

Locations

Country	Name	City	State
United States	The Education and Research Foundation, Inc.	Lynchburg	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe irritation (Grade 3 or 4) observed at any site		Daily for 21 days