Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail

NCT01278394 | Completed Phase 2 Results

• 3 other identifiers: AN2690-ONYC-201AN2690-ONYC-201 Cohort 3C3371009
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to determine the safety and efficacy of 5.0% AN2690 Solution in the treatment of distal, subungual onychomycosis of the great target toenail.

Conditions

Onychomycosis

Keywords

Onychomycosis; Fungal Nail

Outcome Measures

Primary Outcomes (1)

• Clinical Evidence of Complete Clearance of the Treatment-targeted Great Toenail Plus a Negative Fungal Culture at Day 360

  Proportion of subjects with a clinical assessment of a clear (completely normal) nail unit plus a negative fungal culture from the treatment-targeted toenail at Day 360.

  Day 360

Secondary Outcomes (6)

• Clear Nail Growth of the Targeted Toenail

  Day 360

• Mycological Evaluations (Negative Potassium Hydroxide (KOH) and Negative Fungal Culture) Compared to Baseline

  Day 90

• Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline

  Day 180

• Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline

  Day 270

• Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline

  Day 360

Study Arms (1)

Group 1

EXPERIMENTAL

AN2690 Solution, 5.0%

Drug: AN2690 Solution, 5.0%

Interventions

AN2690 Solution, 5.0% DRUG

Once daily application for 360 days

Group 1

Eligibility Criteria

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

You may qualify if:

• Subjects must meet all of the following criteria to be included in the study:
• Witnessed, signed informed consent approved by Ethics Committee.
• Male or female subjects of any race at least 18 years of age but not older than 65 years of age at the time of screening.
• For Cohorts 1 and 2, subjects with a diagnosis of onychomycosis of at least one great toenail and with a positive KOH wet mount from that nail. For Cohort 3, subjects must have a diagnosis of onychomycosis of at least one great toenail and a positive KOH wet mount AND fungal culture from that nail.
• Onychomycosis involving 20-60% of the affected great toenail as determined 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 dermatophytes: 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 (2)

Instituto Dermatologico Jalisciense

Guadalajara, Mexico

Location

IMIC

Mexico City, Mexico

Location

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Sheryl Baldwin, RN/Associate Director
• Organization: Anacor Pharmaceuticals, Inc.

clinicaltrials@anacor.com

650-223-8597

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2011
• First Posted: January 17, 2011
• Study Start: March 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: December 6, 2018
• Results First Posted: August 15, 2014

Record last verified: 2018-11

Locations

ME (2)