Clinical trial NCT00730405: Efficacy and Safety Study of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the Efficacy and Safety of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Onychomycosis
Keywords: Distal, Subungual onychomycosis
onychomycosis
nail fungus
Toenail fungus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2008-08-08
Enrollment: 582
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase 2 study to examine how the study drug works and its side effects in subjects with toenail fungus.

Detailed description: A phase 2, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to investigate the efficacy and safety of 4 dose regimens of ORAL albaconazole in subjects with distal subungual onychomycosis. Subjects will take oral study drug for up to 36 weeks and then will be followed for an additional 16 weeks to determine if the study drug was efficacious. Subjects will have routine blood draws and other safety assessments during the study, as well as regular assessments of their toenail fungus

Eligibility criteria: Inclusion Criteria:

* Subject aged 18 to 75 years.
* Diagnosis with distal subungual onychomycosis of the toenails that affects at least one great toe (target toenail).
* Subject is willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures are performed.
* Subject is able to complete the study, comply with study instructions, and take study product orally.
* Sexually active non-lactating females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product and up to the first menses 60 days following the last dose of study product.
* Women of childbearing potential must have a negative pregnancy test at enrollment.
* Subject has screening laboratory parameters and ECG within the normal ranges unless considered to be not clinically relevant by the principal investigator.

Exclusion Criteria:

Subjects with any of the following conditions or characteristics will be excluded from study enrollment (ie, will not receive study product):

* Subject has received an investigational drug within 4 weeks of the first dose of study product, or who are scheduled to receive an investigational drug other than the study product during the study.
* Subject has participated in a clinical trial for the systemic treatment of onychomycosis of the toenails within 6 months prior to the first dose of study product.
* Subject is receiving any drugs that are known substrates of the 3A4 isozyme of cytochrome P450 (CYP3A4) with QT prolongation potential or any of the concomitant medications listed under prohibited medication section.
* Subject has a history of known or suspected intolerance to albaconazole or the formulation excipients, or to azole antifungal drugs in general.
* Subject has previously participated in a clinical study with albaconazole.
* Subject is not prepared to give up use of any nail cosmetic products for the duration of the study.
* Subject has any known immunodeficiency or history of malignancy in the last 4 years, excluding nonmelanoma skin cancer.
* Subject has any known liver disease or a history of liver toxicity with other drugs.
* Subject is currently suffering from any disease or condition, that could include abnormal laboratory tests, and/or who are currently using medication which in the opinion of the investigator may affect the evaluation of the study product or place the subject at undue risk.
* Subject has psoriasis, lichen planus, or other abnormalities that could result in a clinically abnormal toenail.
* Subject has a history of any condition that could possibly affect absorption of drug (eg, gastrectomy), uncontrolled diabetes, clinically significant peripheral vascular disease or peripheral circulatory impairment, or has had any major illness within 30 days prior to the screening examination.
* Subject has a history of drug, prescription medicine, or alcohol abuse within the past 2 years.
* Female subjects who are pregnant, trying to become pregnant, or lactating.
* Employees of Investigator/clinical research organization (CRO) or Stiefel Laboratories, Inc., or an immediate family member (partner, offspring, parents, siblings or sibling's offspring) of an employee.

Primary outcomes:
measure: The Percentage of Participants Who Achieve Effective Treatment at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: The Percentage of Participants Who Achieve Clinical Cure at Week 52
timeFrame: Week 52
measure: The Percentage of Participants Who Achieve Mycological Cure at Week 52
timeFrame: Week 52
measure: The Percentage of Participants Who Achieve Complete Cure at Week 52
timeFrame: Week 52
measure: Absolute Change in Unaffected Part of Target Nail From Baseline to Week 52
timeFrame: Baseline (Week 0/Day 1 or before) and up to Week 52
measure: The Percentage of Participants With a Global Change Score of Cleared or Much Improved at Week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Tucson
country: United States
facility: Genova Clinical Research
state: Arizona
city: Beverly Hills
country: United States
facility: Impact Clinical Trials
state: California
city: Carmichael
country: United States
facility: Northern California Research
state: California
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: San Francisco
country: United States
facility: UCSF Dermatology Research
state: California
city: Colorado Springs
country: United States
facility: Thomas J. Stephens & Associates, Inc. Colorado Research Center
state: Colorado
city: Miami Beach
country: United States
facility: Greater Miami Skin & Laser Center
state: Florida
city: Miami
country: United States
facility: International Dermatology Research Inc
state: Florida
city: North Miami Beach
country: United States
facility: Miami Dermatology Research Institute LLC
state: Florida
city: Newnan
country: United States
facility: MedaPhase, Inc
state: Georgia
city: Snellville
country: United States
facility: Gwinnett Clinical Research Center, Inc.
state: Georgia
city: Evansville
country: United States
facility: Welborn Clinic
state: Indiana
city: Detroit
country: United States
facility: Henry Ford Medical Center
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Omaha
country: United States
facility: Skin Specialists, Inc
state: Nebraska
city: New York
country: United States
facility: NYU Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Portland
country: United States
facility: Oregon Dermatology & Research Centre
state: Oregon
city: Portland
country: United States
facility: Oregon Medical
state: Oregon
city: Knoxville
country: United States
facility: The Skin Wellness Center
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Clinical Research
state: Tennessee
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: College Station
country: United States
facility: J & S Studies, Inc.
state: Texas
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Salt Lake City
country: United States
facility: DermatologyResearch Center
state: Utah
city: Lynchburg
country: United States
facility: Education and Research Foundation
state: Virginia
city: Barrie
country: Canada
facility: Ultranova Skincare
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre Inc.
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research Inc.
state: Ontario
city: Hudlaeknaslodin
country: Iceland
facility: Dermatology Centre, University of Iceland
state: Kopavogur
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Sigurgeirsson B, van Rossem K, Malahias S, Raterink K. A phase II, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study to investigate the efficacy and safety of 4 dose regimens of oral albaconazole in patients with distal subungual onychomycosis. J Am Acad Dermatol. 2013 Sep;69(3):416-25. doi: 10.1016/j.jaad.2013.03.021. Epub 2013 May 22.