Tinea PedisPhase 1NCT00509275
A Study to Evaluate Efficacy and Safety of Three W0027 Regimens in the Treatment of Moccasin Type Tinea Pedis (MTTP)
A Phase 1 study testing W0027 in people with Tinea Pedis, run by Stiefel, a GSK Company at 9 sites in 2 countries.
Trial summary
In this phase Ib, multi-centre, randomized, double-blind, placebo-controlled parallel group study, 120 subjects with moccasin type tinea pedis (MTTP) will be enrolled at approximately 11 centres in the USA, Canada and Australia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tinea Pedis
- What is being tested?
- W0027
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Jul 2007to Aug 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 18-65 years, who have been diagnosed with moccasin type tinea pedis (by positive dermatophyte culture, positive potassium hydroxide/calcofluor white preparation, and a Total Signs and Symptoms Score of at least 4).
- Females of childbearing potential must use contraceptive methods .
Who cannot join
- Subjects who are receiving any CYP3A substrates with potential for QT prolongation;
- have used systemic antifungal drugs within 30 days of first dose; or topical antifungals within 2 weeks of first dose.
- Also excluded are those who have a clinically significant medical condition.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Australia5 sites
The Skin Centre
Benowa, Queensland, QLD 4217
South East Dermatology
Carina, Queensland, QLD 4152
Skin and Cancer Foundation
Carlton, Victoria, VIC 3053
St George Dermatology and Skin Cancer Centre
Kogarah, New South Wales, NSW 2217
Dermatology on Ward
North Adelaide, South Australia, SA 5006
United States4 sites
Study site
Albuquerque, New Mexico, 87106
University Dermatology Consultants, Inc.
Cincinnati, Ohio, 45219
Dermatology Specialists
Louisville, Kentucky, 40202
Study site
Warren, Michigan, 48088
About this study
Official title: A Phase Ib, Randomized, Double Blind, Placebo Controlled Study to Investigate the Pharmacokinetics, Safety and Efficacy of 3 Different Doses of W0027 and Placebo Capsules in Subjects With Clinically and Mycologically Proven MTTP
In this phase Ib, multi-centre, randomized, double-blind, placebo-controlled parallel group study, 120 subjects with moccasin type tinea pedis (MTTP) will be enrolled at approximately 11 centres in the USA, Canada and Australia.
The primary objective of the study is to assess the patient response to three W0027 regimens in subjects with MTTP. Secondary objectives include assessment of the safety, tolerability and skin and nail pharmacokinetics to the three Albaconazole regimens.
- Conditions
- Tinea Pedis
- Being tested
- W0027, Placebo
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
W0027Drug
capsule
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | W0027 Receives: Drug: W0027 |
| 2 | Experimental | W0027 Receives: Drug: W0027 |
| 3 | Experimental | W0027 Receives: Drug: W0027 |
| 4 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to assess the subject response to three W0027 regimens in subjects with MTTP.
Measured: Week 8
Secondary outcomes (1)
The secondary objectives of this study are: To assess the safety and tolerability of three W0027 regimens in subjects with MTTP; To assess skin and nail pharmacokinetics of three Albaconazole doses in subjects with MTTP.
Measured: Skin and Plasma samples Week 0 (Visit 2) through to Week 8 (Visit 9), Nail samples Week 0 (Visit 2) Week 4(Visit 7) and Week 8(Visit 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinea PedisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiefel, a GSK Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Lynda Spelman, MD, Principal investigator, South East Dermatology, South East Dermatology, Carina QLD 4152, AustraliaMichael Freeman, MD, Principal investigator, The Skin Centre, Benowa QLD 4217, AustraliaPeter Foley, MD, Principal investigator, Skin and Cancer Foundation, Carlton VIC 3053 , AustraliaStephen Shumack, MD, Principal investigator, St George Dermatology and Skin Cancer Centre, Kogarah NSW 2217, AustraliaWarren Weightman, MD, Principal investigator, Dermatology on Ward, North Adelaide SA 5006, AustraliaDebra Breneman, MD, Principal investigator, University Dermatology Consultants, Inc., Cincinnati, OH, 45219, USEduardo Tschen, MD, Principal investigator, Albuquerque, NM 87106, USYves Poulin, MD, Principal investigator, Centre de Dermatologie de Québec Métropolitain, Quebec, QC, G1V 4X7, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509275
- Sponsor's protocol ID
- W0027-08
- Status last verified
- May 2017
- First submitted
- 30 Jul 2007
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Randomized, Double Blind, Placebo Controlled Study to Investigate the Pharmacokinetics, Safety and Efficacy of 3 Different Doses of W0027 and Placebo Capsules in Subjects With Clinically and Mycologically Proven MTTP
- ClinicalTrials.gov ID
- NCT00509275
- Acronym / sponsor ID
- W0027-08
- Conditions
- Tinea Pedis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Jul 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 31 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this phase Ib, multi-centre, randomized, double-blind, placebo-controlled parallel group study, 120 subjects with moccasin type tinea pedis (MTTP) will be enrolled at approximately 11 centres in the USA, Canada and Australia.
The primary objective of the study is to assess the patient response to three W0027 regimens in subjects with MTTP. Secondary objectives include assessment of the safety, tolerability and skin and nail pharmacokinetics to the three Albaconazole regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: W0027W0027 |
| 2 | Experimental | Drug: W0027W0027 |
| 3 | Experimental | Drug: W0027W0027 |
| 4 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects aged 18-65 years, who have been diagnosed with moccasin type tinea pedis (by positive dermatophyte culture, positive potassium hydroxide/calcofluor white preparation, and a Total Signs and Symptoms Score of at least 4).
- Females of childbearing potential must use contraceptive methods .
Key exclusion criteria (3 listed)
- Subjects who are receiving any CYP3A substrates with potential for QT prolongation;
- have used systemic antifungal drugs within 30 days of first dose; or topical antifungals within 2 weeks of first dose.
- Also excluded are those who have a clinically significant medical condition.
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 |
|---|---|---|
| W0027capsule | Drug | 1, 2, 3 |
| PlaceboPlacebo | Drug | 4 |
Primary outcome
The primary objective of this study is to assess the subject response to three W0027 regimens in subjects with MTTP.
Time frame: Week 8
1 secondary outcome
The secondary objectives of this study are: To assess the safety and tolerability of three W0027 regimens in subjects with MTTP; To assess skin and nail pharmacokinetics of three Albaconazole doses in subjects with MTTP.
Time frame: Skin and Plasma samples Week 0 (Visit 2) through to Week 8 (Visit 9), Nail samples Week 0 (Visit 2) Week 4(Visit 7) and Week 8(Visit 9)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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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.
Lynda Spelman, MD principal investigator
South East Dermatology, South East Dermatology, Carina QLD 4152, Australia
Michael Freeman, MD principal investigator
The Skin Centre, Benowa QLD 4217, Australia
Peter Foley, MD principal investigator
Skin and Cancer Foundation, Carlton VIC 3053 , Australia
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing W0027 in people with Tinea Pedis, run by Stiefel, a GSK Company at 9 sites in 2 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 2 inclusion and 3 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Australia, United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary objective of this study is to assess the subject response to three W0027 regimens in subjects with MTTP. (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2017.