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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00509275




Registration number
NCT00509275
Ethics application status
Date submitted
30/07/2007
Date registered
31/07/2007
Date last updated
30/05/2017

Titles & IDs
Public title
A Study to Evaluate Efficacy and Safety of Three W0027 Regimens in the Treatment of Moccasin Type Tinea Pedis (MTTP)
Scientific 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
Secondary ID [1] 0 0
W0027-08
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tinea Pedis 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - W0027
Treatment: Drugs - Placebo

Experimental: 1 - W0027

Experimental: 2 - W0027

Experimental: 3 - W0027

Placebo comparator: 4 - Placebo


Treatment: Drugs: W0027
capsule

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary objective of this study is to assess the subject response to three W0027 regimens in subjects with MTTP.
Timepoint [1] 0 0
Week 8
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
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)

Eligibility
Key inclusion criteria
* 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 .
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2008
Sample size
Target
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
St George Dermatology and Skin Cancer Centre - Kogarah
Recruitment hospital [2] 0 0
The Skin Centre - Benowa
Recruitment hospital [3] 0 0
South East Dermatology - Carina
Recruitment hospital [4] 0 0
Dermatology on Ward - North Adelaide
Recruitment hospital [5] 0 0
Skin and Cancer Foundation - Carlton
Recruitment postcode(s) [1] 0 0
NSW 2217 - Kogarah
Recruitment postcode(s) [2] 0 0
QLD 4217 - Benowa
Recruitment postcode(s) [3] 0 0
QLD 4152 - Carina
Recruitment postcode(s) [4] 0 0
SA 5006 - North Adelaide
Recruitment postcode(s) [5] 0 0
VIC 3053 - Carlton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Kentucky
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
New Mexico
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Stiefel, a GSK Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
GlaxoSmithKline
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lynda Spelman, MD
Address 0 0
South East Dermatology, South East Dermatology, Carina QLD 4152, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00509275