|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT01396811 |
|
Date of registration:
|
15/07/2011 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Topical Antifungal Treatment for Tinea Pedis
|
|
Scientific title:
|
A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Product 33525 in Subjects With Tinea Pedis |
|
Date of first enrolment:
|
July 2011 |
|
Target sample size:
|
322 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01396811 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Belize
|
United States
| | | | | | |
|
Contacts
|
|
Name:
|
Ron Staugaard |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Medicis Pharmaceutical |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Moderate erythema, moderate scaling, and mild pruritus
Exclusion Criteria:
- Pregnancy and allergies
Age minimum:
12 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Tinea Pedis
|
|
Intervention(s)
|
|
Drug: 33525
|
|
Drug: Placebo
|
|
Primary Outcome(s)
|
|
Proportion of patients achieving complete clearance
[Time Frame: Day 42]
|
|
Secondary Outcome(s)
|
|
Proportion of patients achieving effective treatment
[Time Frame: Day 42]
|
|
Secondary ID(s)
|
|
MP-1000-03
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|