Study of Different Doses of a Novel Treatment for Onychomycosis

NCT00679965 | Completed Phase 2

• 2 other identifiers: AN2690-ONYC-200C3371001
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of the study is to determine the safety and efficacy of 2.5%, 5.0%, and 7.5% AN2690 Solutions compared to the vehicle alone in the treatment of distal, subungual onychomycosis of the great target toenail.

Conditions

Distal, Subungual Onychomycosis

Keywords

Onychomycosis; Fungal Nail

Outcome Measures

Primary Outcomes (1)

• Clinical evidence of complete great toenail clearance or at least fungal-clear great toenail growth ("complete" = 5mm; "partial" = 2mm), plus a negative fungal culture from the treatment-targeted great toenail.

  Day 180

Secondary Outcomes (1)

• Absence of signs and symptoms of onychomycosis plus a negative fungal culture & negative KOH from the treatment-targeted toenail.

  Day 360

Study Arms (4)

Group 1

EXPERIMENTAL

AN2690 Solution, 2.5%

Drug: AN2690, 2.5%

Group 2

EXPERIMENTAL

AN2690 Solution: 5%

Drug: AN2690, 5%

Group 3

EXPERIMENTAL

AN2690 Solution, 7.5%

Drug: AN2690, 7.5%

Group 4

PLACEBO COMPARATOR

AN2690 Solution Vehicle

Drug: AN2690 Solution Vehicle

Interventions

AN2690, 2.5% DRUG

Once daily application for 90 days and 3 x weekly for 90 days

Group 1

AN2690, 5% DRUG

Once daily application for 90 days and 3 x weekly for 90 days

Group 2

AN2690, 7.5% DRUG

Once daily application for 90 days and 3 x weekly for 90 days

Group 3

AN2690 Solution Vehicle DRUG

Once daily application for 90 days and 3x weekly for 90 days

Group 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Witnessed, signed informed consent approved by Institutional Review Board/Ethics Committee.
• Male or female subjects of any race at least 18 years of age but not older than 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 a dermatophyte.
• Onychomycosis involving 20-60% of the affected great toenail as determined at baseline (Day 1) 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.
• Normal or not clinically significant screening safety labs.

You may not qualify if:

• 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.
• Diabetes mellitus requiring treatment other than diet and exercise.
• Subjects with chronic moccasin type of T. pedis.
• Subjects with a history of having failed any previous topical antifungal therapy for their onychomycosis.
• 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 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:
• Topical antifungal applied to the feet (does not include antifungals for treatment of T. pedis during the study): 4 weeks
• Anti-inflammatories, corticosteroids, topical immunomodulators: 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:
• Corticosteroids (including intramuscular injections): 2 weeks
• Antifungals for treatment of onychomycosis or any systemic antifungal with known activity against dermatophyte: 24 weeks
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (9)

Unidad de Investigación en Salud (UIS)

Chihuahua City, Mexico

Location

Hospital "Dr. Angel Leaño"

Guadalajara, Mexico

Location

Instituto Dermatologico Jalisciense

Guadalajara, Mexico

Location

Centro Dermatologico Pascua

Mexico City, Mexico

Location

CIF-BIOTEC Medica Sur.

Mexico City, Mexico

Location

IMIC

Mexico City, Mexico

Location

Hospital Universitario Dr. José Eleuterio González

Monterrey, Mexico

Location

MIRC / OCA Hospital

Monterrey, Mexico

Location

ISSEMYM

Toluca, Mexico

Location

MeSH Terms

Conditions

Onychomycosis

Interventions

tavaborole

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2008
• First Posted: May 19, 2008
• Study Start: February 28, 2006
• Primary Completion: July 31, 2007
• Study Completion: July 31, 2007
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

ME (9)