OnychomycosisPhase 3NCT00356915
Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.
A Phase 3 study testing Itraconazole 100mg capsules and Itraconazole 200mg tablets in people with Onychomycosis, run by Stiefel, a GSK Company at 68 sites in 7 countries.
Trial summary
Onychomycosis is a common condition accounting for approximately half of all nail disorders. It is most commonly caused by dermatophytes. Itraconazole has been approved for the treatment of onychomycosis in the United States with an approved dosage regimen for the treatment of onychomycosis of the toenail of once… Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- Itraconazole 100mg capsules and Itraconazole 200mg tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,381 participants
- Where
- 68 sitesin 7 countries
- Study dates
- Jul 2006to Oct 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of onychomycosis of at least one great toenail
- Percent Nail Involvement Score of the more severely affected great toenail (the Target Toenail) must be between 2 and 3 (25-75% of the nail unit).
- Length of Unaffected Part of the Target Toenail ≥2mm
- Direct microscopic examination with KOH that is positive for the hyphae associated with dermatophytes on the target toenail
- Subjects must have signed informed consent
- If the subject is woman of childbearing potential, she must have a negative urine pregnancy test and agree to use an effective form of birth control until the first menses after 60 days following the last dose of study medication.
Who cannot join
- Onychomycosis caused by Candida spp. without the presence of a dermatophyte
- Participation in a clinical trial for the systemic treatment of onychomycosis of the toenail within 24 weeks prior to Visit 1
- Use of systemic antifungals within 12 weeks prior to Visit 1
- Use of topical antifungal nail lacquer within 30 days prior to Visit 1
- Use of any other topical onychomycosis treatment on any toenail within 7 days prior to Visit 1
- Evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF
- Known liver disease or a history of liver toxicity with other drugs
- Use of systemic immunosuppressants
Trial locations and contacts
68 sites in 7 countries.
68 sites in 7 countries
United States52 sites
Dr. Eduardo Tschen
Albuquerque, New Mexico, 87106
Radiant Research - Anderson
Anderson, South Carolina, 29621
Dr. David Fivenson
Ann Arbour, Michigan, 48103
Radiant Research - Atlanta West
Austell, Georgia, 30106
DermResearch Inc.
Austin, Texas, 78759
Dr. Stephen Horwitz
Aventure, Florida, 33180
Radiant Research -Birmingham
Birmingham, Alabama, 35209
University of Alabama School of Medicine
Birmingham, Alabama, 35233
Northwest Clinical Trials
Boise, Idaho, 83704
Dr. Terry Jones
Bryan, Texas, 77802
Radiant Research - Chicago
Chicago, Illinois, 60610
Dermatology Clinical Research Center
Cincinnati, Ohio, 45219
Radiant Research - Cincinnati
Cincinnati, Ohio, 45249
Radiant Research - Dallas North
Dallas, Texas, 75231
Meridian Skincare
Englewood, Colorado, 80112
East Bay Dermatology Medical Group Inc.
Fremont, California, 94538
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Dermatology East
Germantown, Tennessee, 38138
Radiant Research - Greenville
Greenville, South Carolina, 29617
Dr. J. M. Humeniuk
Greer, South Carolina, 29651
Dermatology Consulting Services
High Point, North Carolina, 27262
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
Dermatology Associates of Knoxville
Knoxville, Tennessee, 37917
Madison Skin and Research Inc.
Madison, Wisconsin, 53719
International Dermatology Research Inc.
Miami, Florida, 33144
FMX Research Corporation
Miami, Florida, 33175
Advanced Healthcare S. C.
Milwaukee, Wisconsin, 53209
VA Medical Center
Minneapolis, Minnesota, 55417
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
The Savin Center
New Haven, Connecticut, 06511
Skin Specialty Group
New York, New York, 10021
Columbia University Medical Center
New York, New York, 10032
Pariser Dermatology Specialists Ltd.
Norfolk, Virginia, 235507
Advanced Dermatology and Cosmetic Surgery
Ormond Beach, Florida, 32174
Radiant Research - Kansas City
Overland Park, Kansas, 66215
Northwest Cutaneous Research
Portland, Oregon, 97210
Oregon Medical Research Center
Portland, Oregon, 97223
Rhode Island Hospital
Providence, Rhode Island, 02903
Dermatology Research Center
Salt Lake City, Utah, 84124
Dr. Stephen Miller
San Antoinio, Texas, 78229
Endeavor Clinical Trials
San Antonio, Texas, 78229
Skin Surgey Medical Group
San Diego, California, 92117
Therapeutics Clinical Research
San Diego, California, 92123
University of California
San Francisco, California, 94143-0517
Radiant Research - Santa Rosa
Santa Rosa, California, 95405
Gwinnett Clinical Research Center Inc.
Snellville, Georgia, 30078
Radiant Research - St. Petersburg
St. Petersburg, Florida, 33781
Radiant Research - Tacoma
Tacoma, Washington, 98499
Skin and Vein Center
Troy, Michigan, 48083
Radiant Research - Tucson
Tuscon, Arizona, 85710
South Valley Dermatology Center
West Jordan, Utah, 84088
Radiant Research - West Palm Beach
West Palm Beach, Florida, 33407
Canada8 sites
Dr. Kirk Barber
Calgary, Alberta, T2S3B3
Dr. Aditja Gupta
London, Ontario, N5X2P1
Dr. Chuck Lynde
Markham, Ontario, L3P7N8
Dr. Marc Bourcier
Moncton, New Brunswick, E1C8X3
Dr. Robert Bissonnette
Montreal, Quebec, H2K4L5
EntraLogix
Oakville, Ontario, L6K1E1
Dr. Richard Thomas
Vancouver, British Columbia, V5Z3Y1
Dr. Jerry Tan
Windsor, Ontario, N8W5L7
South Africa4 sites
Langeberg Medical Centre
Cape Town
University of Cape Town
Cape Town
Dr. Z. F. Ahmed Vawda
Durban
DJW Navorsing
Krugerson
Dominican Republic1 site
Edifico Professional Guarionex Lopez
Santo Domingo
About this study
Official title: A Phase III Randomized, Evaluator-Blind, Parallel Group Study of the Safety and Efficacy of Itraconazole Tablets, Itraconazole Capsules and Placebo in the Treatment of Onychomycosis of the Toenail.
Onychomycosis is a common condition accounting for approximately half of all nail disorders. It is most commonly caused by dermatophytes. Itraconazole has been approved for the treatment of onychomycosis in the United States with an approved dosage regimen for the treatment of onychomycosis of the toenail of once daily (QD) treatment with 200mg of itraconazole (two 100 mg capsules) for 12 weeks. Barrier Therapeutics has developed a 200 mg tablet which could be used in a more convenient one-tablet-per-day dosing regimen. This clinical trial will compare the efficacy and safety of this new tablet formulation with itraconazole capsules and placebo.
Read the detailed description
Onychomycosis is common and accounts for about half of all nail disorders. Usually the cause is due to dermatophytes, either Trichophyton rubrum (71%) or Trichophyton mentagrophytes (20%) but may also be due to yeast infection, usually Candida albicans.
The prevalence of onychomycosis in the United States population as a whole is 13% and is more prevalent in the elderly (60%). Onychomycosis of the toenail recurs and is thought to have a genetic component.
Onychomycosis can result in permanent nail deformity. This disease has a significant impact on the patient's quality of life (e.g., concern with the appearance of the toenails and fingernails, interference with wearing shoes, walking and sports activities).
Itraconazole has been approved for the treatment of onychomycosis in the United States since the mid-nineteen-nineties. The approved dosage regimen for treatment of onychomycosis of the toenail is once daily (QD) treatment with 200 mg of itraconazole (Sporanox®, Janssen Pharmaceutical Products, L.P., Titusville, NJ, USA) for 12 weeks. The approved dosage form is a 100mg capsule. Barrier Therapeutics has developed a 200mg tablet which could be used in a more convenient one-tablet-per-day dosing regimen.
This clinical trial will compare the efficacy and safety of this new tablet formulation with itraconazole capsules and placebo.
- Conditions
- Onychomycosis
- Being tested
- Itraconazole 100mg capsules, Itraconazole 200mg tablets, Placebo tablets
- Keywords
- Nail fungus, Onychomycosis, Itraconazole, Toenail
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Itraconazole 100mg capsulesDrug
Also called Sporanox®
Subjects took two 100mg capsules once per day after a full meal. The dose dose was taken the day before the Week 12 visit.
Itraconazole 200mg tabletsDrug
Also called Onmel
Subjects took one 200mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.
Placebo tabletsDrug
Also called placebo
Placebo tablets are the same as the Itraconazole tablets but without the active drug included. Subjects took one tablet once per day after a full meal. The last tablet was taken the day before the Week 12 visit.
| Study group | Role | What they receive |
|---|---|---|
| Itraconazole tablets | Experimental | Itraconazole 200 mg tablets Receives: Drug: Itraconazole 200mg tablets |
| Itraconazole capsules | Active comparator | Two Itraconazole 100 mg capsules were taken daily. Receives: Drug: Itraconazole 100mg capsules |
| Placebo tablets | Placebo comparator | The itraconazole 200-mg tablets and placebo tablets exactly matched one another and were white to slightly grey in color, were oblong and biconvex in shape, and were melt-extrusion, film-coated. Receives: Drug: Placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and Mycological Cure of Target Toenail
This study was designed to evaluate the superiority of itraconazole tablets to placebo tablets.
Clinical Cure was defined as an IGA score of 0 for the target toenail; Mycological Cure was defined as a negative potassium hydroxide (KOH) exam and a negative culture for dermatophytes of the target toenail.
Measured: 1 year
Complete Cure - Itraconazole Tablets Compared to Itraconazole Capsules
The primary efficacy endpoint was Compete Cure (consisting of a Clinical Cure and a Mycological Cure) at week 52. In this study, Clinical Cure was defined as an Investigator's Global Assessment (IGA) score of 0 for the target toenail; Mycological Cure was defined as a negative potassium hydroxide (KOH) examination and a negative culture outcome for dermatophytes of the target toenail. The efficacy analyses were conducted to demonstrate the non-inferiority of 1 itraconazole 200-mg tablet to 2 itraconazole 100-mg capsule.
Measured: 12 months
Secondary outcomes (2)
Clinical Improvement of the Target Toenail
Clinical Improvement consisted of a mycological cure and an Investigator's Global Assessment (IGA) score less than or equal to 1 at week 52.
The Investigator's Global Assessment (IGA) assesses the overall severity of onychomycosis on the target toenail and takes into consideration, onycholysis, hyperkeratosis and percent nail involvement.
0 = Clinical Cure: No evidence of onychomycosis.
1 = Clinical Improvement: Minimal evidence of onychomycosis. 2 = Mild: ≤25% dystrophy and/or onycholysis. 3 = Moderate: ≤50% dystrophy with onycholysis. 4 = Severe: >50% dystrophy with onycholysis.
Measured: 12 months
Clinical Improvement Compared to Placebo
Clinical Improvement consisted of a mycological cure and an Investigator's Global Assessment (IGA) score less than or equal to 1 at week 52.
The Investigator's Global Assessment(IGA)assesses the overall severity of onychomycosis on the target toenail and takes into consideration, onycholysis, hyperkeratosis and percent nail involvement.
0 = Clinical Cure: No evidence of onychomycosis.
1 = Clinical Improvement: Minimal evidence of onychomycosis. 2 = Mild: ≤25% dystrophy and/or onycholysis. 3 = Moderate: ≤50% dystrophy with onycholysis. 4 = Severe: >50% dystrophy with onycholysis.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OnychomycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiefel, a GSK Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00356915
- Sponsor's protocol ID
- BT0300-302-INT
- Status last verified
- Dec 2016
- First submitted
- 25 Jul 2006
- Last updated
- 9 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Maddin S, Quiring J, Bulger L. Randomized, placebo-controlled, phase 3 study of itraconazole for the treatment of onychomycosis. J Drugs Dermatol. 2013 Jul 1;12(7):758-63.
PubMed 23884486
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized, Evaluator-Blind, Parallel Group Study of the Safety and Efficacy of Itraconazole Tablets, Itraconazole Capsules and Placebo in the Treatment of Onychomycosis of the Toenail.
- ClinicalTrials.gov ID
- NCT00356915
- Acronym / sponsor ID
- BT0300-302-INT
- Conditions
- Onychomycosis
- Keywords
- Nail fungus, Onychomycosis, Itraconazole, Toenail
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,381 participants (actual)
- Lead sponsor
- Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Jul 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 27 Jul 2006 (estimated)
- Results
- Posted 4 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Onychomycosis is a common condition accounting for approximately half of all nail disorders. It is most commonly caused by dermatophytes. Itraconazole has been approved for the treatment of onychomycosis in the United States with an approved dosage regimen for the treatment of onychomycosis of the toenail of once daily (QD) treatment with 200mg of itraconazole (two 100 mg capsules) for 12 weeks. Barrier Therapeutics has developed a 200 mg tablet which could be used in a more convenient one-tablet-per-day dosing regimen. This clinical trial will compare the efficacy and safety of this new tablet formulation with itraconazole capsules and placebo.
Detailed description
Onychomycosis is common and accounts for about half of all nail disorders. Usually the cause is due to dermatophytes, either Trichophyton rubrum (71%) or Trichophyton mentagrophytes (20%) but may also be due to yeast infection, usually Candida albicans.
The prevalence of onychomycosis in the United States population as a whole is 13% and is more prevalent in the elderly (60%). Onychomycosis of the toenail recurs and is thought to have a genetic component.
Onychomycosis can result in permanent nail deformity. This disease has a significant impact on the patient's quality of life (e.g., concern with the appearance of the toenails and fingernails, interference with wearing shoes, walking and sports activities).
Itraconazole has been approved for the treatment of onychomycosis in the United States since the mid-nineteen-nineties. The approved dosage regimen for treatment of onychomycosis of the toenail is once daily (QD) treatment with 200 mg of itraconazole (Sporanox®, Janssen Pharmaceutical Products, L.P., Titusville, NJ, USA) for 12 weeks. The approved dosage form is a 100mg capsule. Barrier Therapeutics has developed a 200mg tablet which could be used in a more convenient one-tablet-per-day dosing regimen.
This clinical trial will compare the efficacy and safety of this new tablet formulation with itraconazole capsules and placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Itraconazole tablets | Experimental | Drug: Itraconazole 200mg tabletsItraconazole 200 mg tablets |
| Itraconazole capsules | Active comparator | Drug: Itraconazole 100mg capsulesTwo Itraconazole 100 mg capsules were taken daily. |
| Placebo tablets | Placebo comparator | Drug: Placebo tabletsThe itraconazole 200-mg tablets and placebo tablets exactly matched one another and were white to slightly grey in color, were oblong and biconvex in shape, and were melt-extrusion, film-coated. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of onychomycosis of at least one great toenail
- Percent Nail Involvement Score of the more severely affected great toenail (the Target Toenail) must be between 2 and 3 (25-75% of the nail unit).
- Length of Unaffected Part of the Target Toenail ≥2mm
- Direct microscopic examination with KOH that is positive for the hyphae associated with dermatophytes on the target toenail
- Subjects must have signed informed consent
Key exclusion criteria (8 listed)
- Onychomycosis caused by Candida spp. without the presence of a dermatophyte
- Participation in a clinical trial for the systemic treatment of onychomycosis of the toenail within 24 weeks prior to Visit 1
- Use of systemic antifungals within 12 weeks prior to Visit 1
- Use of topical antifungal nail lacquer within 30 days prior to Visit 1
- Use of any other topical onychomycosis treatment on any toenail within 7 days prior to Visit 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Itraconazole 100mg capsulesAlso: Sporanox®Subjects took two 100mg capsules once per day after a full meal. The dose dose was taken the day before the Week 12 visit. | Drug | Itraconazole capsules |
| Itraconazole 200mg tabletsAlso: OnmelSubjects took one 200mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit. | Drug | Itraconazole tablets |
| Placebo tabletsAlso: placeboPlacebo tablets are the same as the Itraconazole tablets but without the active drug included. Subjects took one tablet once per day after a full meal. The last tablet was taken the day before the Week 12 visit. | Drug | Placebo tablets |
Primary outcome
Clinical and Mycological Cure of Target Toenail
Time frame: 1 year
This study was designed to evaluate the superiority of itraconazole tablets to placebo tablets. Clinical Cure was defined as an IGA score of 0 for the target toenail; Mycological Cure was defined as a negative potassium hydroxide (KOH) exam and a negative culture for dermatophytes of the target toenail.
Complete Cure - Itraconazole Tablets Compared to Itraconazole Capsules
Time frame: 12 months
The primary efficacy endpoint was Compete Cure (consisting of a Clinical Cure and a Mycological Cure) at week 52. In this study, Clinical Cure was defined as an Investigator's Global Assessment (IGA) score of 0 for the target toenail; Mycological Cure was defined as a negative potassium hydroxide (KOH) examination and a negative culture outcome for dermatophytes of the target toenail. The efficacy analyses were conducted to demonstrate the non-inferiority of 1 itraconazole 200-mg tablet to 2 itraconazole 100-mg capsule.
2 secondary outcomes
Clinical Improvement of the Target Toenail
Time frame: 12 months
Clinical Improvement Compared to Placebo
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23884486Maddin S, Quiring J, Bulger L. Randomized, placebo-controlled, phase 3 study of itraconazole for the treatment of onychomycosis. J Drugs Dermatol. 2013 Jul 1;12(7):758-63.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
68 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Itraconazole 100mg capsules and Itraconazole 200mg tablets in people with Onychomycosis, run by Stiefel, a GSK Company at 68 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in United States, Canada, South Africa, Dominican Republic, Ecuador and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and Mycological Cure of Target Toenail (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00356915, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.