Status:
COMPLETED
Safety & Efficacy Study of HTU-520 in the Treatment of Distal Subungual Onychomycosis of the Toenail
Lead Sponsor:
Hisamitsu Pharmaceutical Co., Inc.
Conditions:
Onychomycosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of HTU-520 in subjects with clinically diagnosed onychomycosis of the great toenail.
Detailed Description
A Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled Study of the Safety \& Efficacy of HTU-520 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenai...
Eligibility Criteria
Inclusion
- Clinical diagnosis of DSO for at least one great toenail
- Direct microscopy of subungual debris positive for hyphal elements (KOH test)
- Culture confirmation of the growth of a dermatophyte
- Good general health
- Willing to refrain from using any lotions, creams, liquids, or polish on treated toenails
- Willing to refrain from receiving pedicures for the duration of the study
- If female, using an acceptable form of birth control
Exclusion
- Unable to apply test product onto toenails by him/herself
- Use of topical antifungal agents on the nail within 1 month
- Uncontrolled diabetes
- Onychomycosis of the fingernails
- Confirmed non-dermatophyte infection of the target toenail
- Structural deformities of the target toenail, open wounds, lesions, sores, surgery on the feet or toenails
- History of severe or chronic immunosuppression, an immunocompromised condition
- Any systemic or dermatologic disorder, such as severe eczema, or severe atopic dermatitis
- Psoriasis of the toenails
- Hypersensitivity or allergy to topical preparations (including terbinafine) or adhesive dressings
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT01400594
Start Date
July 1 2011
End Date
January 1 2013
Last Update
June 4 2015
Active Locations (37)
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1
Total Skin and Beauty Dermatology Center
Birmingham, Alabama, United States, 35205
2
Radiant Research, Inc.
Birmingham, Alabama, United States, 35209
3
UAB Department of Dermatology
Birmingham, Alabama, United States, 35233
4
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233