Safety and Efficacy Evaluation of Topically Applied AN2690 Solutions for Subjects With Onychomycosis

Pfizer

Status and phase

Completed

Phase 2

Conditions

Onychomycosis

Treatments

Drug: AN2690

Study type

Interventional

Funder types

Industry

Identifiers

NCT00680134

AN2690-ONYC-203

C3371007 (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to determine the safety and efficacy of 1% and 5% AN2690 solutions in the treatment of distal, subungual onychomycosis of the great toenail.

Full description

The first group of 30 protocol-qualified subjects will be assigned to Treatment Group 1 and given 1% AN2690 Solution. The second group of 30 protocol-qualified subjects will be assigned to Treatment Group 2 and given 5% AN2690 Solution.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Witnessed, signed informed consent approved by Institutional Review Board/Ethics Committee
A signed Health Insurance Portability and Accountability Act (HIPAA) authorization form which permits the use and disclosure of subject's individually identifiable health information for those enrolled in the United States of America
Male or female subjects of any race 18 -65 years of age
Subjects with a diagnosis of onychomycosis of at least one great toenail and with a positive KOH wet mount and a positive fungal culture for dermatophyte species
Onychomycosis involving 20-60% of the affected great toenail as determined at baseline (Day1) by visual inspection after the nail has been trimmed
The combined thickness of the distal nail plate and the associated hyperkeratotic nail bed <3 mm
Affected great toenail to be treated is capable of re-growth as documented by history or recent observation of at least 2 mm of growth

Exclusion criteria

Females of childbearing potential not using a highly effective method of birth control (e.g. implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices) during the study
Subjects unwilling to refrain from the use of nail cosmetics such as clear and or colored nail lacquers from the screening visit until the end of the study
Subjects with chronic moccasin type of T. pedis
Subjects with a history of having failed any previous topical antifungal therapy for their onychomycosis
Diabetes mellitus requiring treatment other than diet and exercise
Subjects that have not undergone the specified washout period(s) for the following topical preparations or subjects who require the concurrent use of any of the following topical medications:
1. Topical antifungal applied to toenails (does not include antifungals for treatment of T. pedis): 12 weeks
2. Anti-inflammatories, corticosteroids, topical immunomodulators (in the treatment area): 2 weeks
Subjects that have not undergone the specified washout period(s) for the following systemic medications or subjects who require the concurrent use of any of the following systemic medications:
1. Corticosteroids (including intramuscular injections): 2 weeks
2. Antifungals for treatment of onychomycosis or any systemic antifungal with known activity against dermatophyte species: 24 weeks
3. Systemic immunomodulators: 4 weeks
Treatment of any type for cancer within the last 6 months
History of any significant internal disease
Subjects with a medical history of current or past psoriasis of the skin and/or nails
Concurrent lichen planus
Subjects who are known to be allergic to any of the test product(s) or any components in the test product(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure
Nail or anatomic abnormalities of the toe, e.g., genetic nail disorders, primentary disorders, onychogryphosis, trauma to the nail(s) to be treated
AIDS or AIDS related complex
History of street drug or alcohol abuse
Any subject not able to meet the study attendance requirements
Subjects who have participated in any other trial of an investigational drug or device within 60 days prior to enrollment or participation in a research study concurrent with this study