Efficacy and Safety Study of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis
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
1 other identifier
interventional
582
3 countries
33
Brief Summary
Phase 2 study to examine how the study drug works and its side effects in subjects with toenail fungus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2008
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 16, 2008
CompletedFirst Submitted
Initial submission to the registry
August 4, 2008
CompletedFirst Posted
Study publicly available on registry
August 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 19, 2010
CompletedResults Posted
Study results publicly available
February 7, 2018
CompletedMarch 12, 2018
January 1, 2018
1.6 years
August 4, 2008
December 4, 2017
February 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Percentage of Participants Who Achieve Effective Treatment at Week 52
At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Effective treatment was defined as a mycological cure and clear or almost clear nail (distal subungual hyperkeratosis and/or onycholysis leaving less than 10% of nail plate effected). Comparisons were carried out in a sequential step-down fashion, combined with the Holm procedure at step 2. P-value was based on a sequential step-down combined with the Holm procedure. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52.
Week 52
Secondary Outcomes (5)
The Percentage of Participants Who Achieve Clinical Cure at Week 52
Week 52
The Percentage of Participants Who Achieve Mycological Cure at Week 52
Week 52
The Percentage of Participants Who Achieve Complete Cure at Week 52
Week 52
Absolute Change in Unaffected Part of Target Nail From Baseline to Week 52
Baseline (Week 0/Day 1 or before) and up to Week 52
The Percentage of Participants With a Global Change Score of Cleared or Much Improved at Week 52
Week 52
Study Arms (5)
Albaconazole 100mg
ACTIVE COMPARATORAlbaconazole for 36 weeks
Albaconazole 200mg
ACTIVE COMPARATORAlbaconazole for 36 weeks
Albaconazole 400mg
ACTIVE COMPARATORAlbaconazole for 36 weeks
Albaconazole 400mg 24 weeks, Placebo 12 weeks
ACTIVE COMPARATORAlbaconazole for 24 weeks, Placebo for 12 weeks
Placebo 400 mg
PLACEBO COMPARATORPlacebo for 36 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stiefel, a GSK Companylead
- GlaxoSmithKlinecollaborator
Study Sites (33)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Genova Clinical Research
Tucson, Arizona, 85791, United States
Impact Clinical Trials
Beverly Hills, California, 90211, United States
Northern California Research
Carmichael, California, 95608, United States
Center for Dermatology Clinical Research
Fremont, California, 94538, United States
Therapeutics Clinical Research
San Diego, California, 92123, United States
UCSF Dermatology Research
San Francisco, California, 94115, United States
Thomas J. Stephens & Associates, Inc. Colorado Research Center
Colorado Springs, Colorado, 80915, United States
International Dermatology Research Inc
Miami, Florida, 33144, United States
Greater Miami Skin & Laser Center
Miami Beach, Florida, 33140, United States
Miami Dermatology Research Institute LLC
North Miami Beach, Florida, 33169, United States
MedaPhase, Inc
Newnan, Georgia, 30263, United States
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia, 30078, United States
Welborn Clinic
Evansville, Indiana, 47713, United States
Henry Ford Medical Center
Detroit, Michigan, 48202, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
Skin Specialists, Inc
Omaha, Nebraska, 68144, United States
NYU Medical Center
New York, New York, 10016, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Oregon Dermatology & Research Centre
Portland, Oregon, 97210, United States
Oregon Medical
Portland, Oregon, 97223, United States
The Skin Wellness Center
Knoxville, Tennessee, 37922, United States
Tennessee Clinical Research
Nashville, Tennessee, 37215, United States
DermResearch, Inc.
Austin, Texas, 78759, United States
J & S Studies, Inc.
College Station, Texas, 77845, United States
Research Across America
Dallas, Texas, 75234, United States
Center for Clinical Studies
Houston, Texas, 77058, United States
DermatologyResearch Center
Salt Lake City, Utah, 84124, United States
Education and Research Foundation
Lynchburg, Virginia, 24501, United States
Ultranova Skincare
Barrie, Ontario, L4M 6L2, Canada
North Bay Dermatology Centre Inc.
North Bay, Ontario, P1B 3Z7, Canada
K. Papp Clinical Research Inc.
Waterloo, Ontario, N2J 1C4, Canada
Dermatology Centre, University of Iceland
Hudlaeknaslodin, Kopavogur, 201, Iceland
Related Publications (1)
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.
PMID: 23706639BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
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
August 4, 2008
First Posted
August 8, 2008
Study Start
July 16, 2008
Primary Completion
February 19, 2010
Study Completion
February 19, 2010
Last Updated
March 12, 2018
Results First Posted
February 7, 2018
Record last verified: 2018-01