Cumulative Irritation Test

Pfizer

Status and phase: Completed; Phase 1

Conditions: Onychomycosis

Treatments: Other: Sodium Lauryl Sulfate, 0.5%; Drug: AN2690; Other: AN2690 Solution, Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00680095

AN2690-ONYC-101

C3371011 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

37 participants in 5 patient groups

A

Experimental group

Description:

AN2690 Solution, 2.5%

Treatment:

Drug: AN2690

Drug: AN2690

Drug: AN2690

B

Experimental group

Description:

AN2690 Solution, 7.5%

Treatment:

Drug: AN2690

Drug: AN2690

Drug: AN2690

C

Experimental group

Description:

AN2690 Solution, 5.0%

Treatment:

Drug: AN2690

Drug: AN2690

Drug: AN2690

D

Active Comparator group

Description:

AN2690 Solution, Vehicle

Treatment:

Other: AN2690 Solution, Vehicle

E

Active Comparator group

Description:

Sodium Lauryl Sulfate, 0.5%

Treatment:

Other: Sodium Lauryl Sulfate, 0.5%