OnychomycosisPhase 2NCT01400594

Safety & Efficacy Study of HTU-520 in the Treatment of Distal Subungual Onychomycosis of the Toenail

A Phase 2 study testing HTU-520 Patch in people with Onychomycosis, run by Hisamitsu Pharmaceutical Co., Inc. at 37 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Onychomycosis
What is being tested?: HTU-520 Patch
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 182 participants
Where: 37 sitesUnited States
Study dates: Jul 2011to Jan 2013
Phase: Phase 2
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

37 sites in 1 country.

City, postcode or hospital

37 sites in 1 country

United States37 sites

Radiant Research, Inc.
Akron, Ohio, 44311
Radiant Research, Inc.
Anderson, South Carolina, 29621
Radiant Research, Inc.
Atlanta, Georgia, 30342
Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
Total Skin and Beauty Dermatology Center
Birmingham, Alabama, 35205
Radiant Research, Inc.
Birmingham, Alabama, 35209
UAB Department of Dermatology
Birmingham, Alabama, 35233
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Marta Rendon, MD, Skin Care Research, Inc.
Boca Raton, Florida, 33486
Pab Clinical Research
Brandon, Florida, 33511
Radiant Research, Inc.
Chicago, Illinois, 60654
Group Health Associates, Tri-Health
Cincinnati, Ohio, 45220
Dermatology Research Institute
Coral Gables, Florida, 33146
Radiant Research, Inc.
Dallas, Texas, 75231
Radiant Research, Inc.
Denver, Colorado, 80239
Diagnamics, Inc.
Encinatas, California, 92024
Assoc Foot Clinic & Surgery Specialists
Flint, Michigan, 48503
University of Minnesota, Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Clinical Research Advantage, Inc.
Glendale, Arizona, 85306
Callender center for Clinical Research
Glenn Dale, Maryland, 20769
Silverton Skin Institute
Grand Blanc, Michigan, 48439
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256
Ameriderm Research
Jacksonville, Florida, 32216
Derm Research, LLC
Louisville, Kentucky, 40217
Lake Washington Foot & Ankle Center
Melbourne, Florida, 32935
William P Coleman III, MD
Metairie, Louisiana, 70006
Florida Academic Dermatology Center
Miami, Florida, 33136
Central Sooner Research
Norman, Oklahoma, 73071
Ameriderm Research
Ormond Beach, Florida, 32174
Leavitt Medical Associates ofFL
Ormond Beach, Florida, 32174
Society Hill Dermatology
Philadelphia, Pennsylvania, 19107
Radiant Research, Inc.
Pinellas Park, Florida, 33781
University of Pittsburg Medical Center, Department of Dermatology
Pittsburgh, Pennsylvania, 15213
Radiant Research, Inc.
San Antonio, Texas, 78229
Radiant Research
St Louis, Missouri, 63141
Radiant Research, Inc.
Tucson, Arizona, 85710
Coastal Podiatry Group
Virginia Beach, Virginia, 23464

Other trials in United States

About this study

Official title: 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 Toenail

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.

Read the 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 Toenail

Conditions: Onychomycosis
Being tested: HTU-520 Patch, Placebo Patch
Keywords: Onychomycosis
Medical subject headings: Onychomycosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HTU-520 PatchDrug
Also called HTU-520
Terbinafine hydrochloride patch
Placebo PatchOther
Also called Sham treatment
Treatment with Placebo Patch

Study groups in NCT01400594
Study group	Role	What they receive
HTU-520 Patch	Experimental	Subjects will receive HTU-520 patch in a 1:1 ratio for 48 weeks applied to all toenails. Receives: Drug: HTU-520 Patch
Placebo Patch	Placebo comparator	Subjects will receive placebo patch in a 1:1 ratio for 48 weeks applied to all toenails. Receives: Other: Placebo Patch

What is being measured

The primary outcome is the main question the study is designed to answer.

Determination of status with respect to complete cure (mycological cure together with clinical cure) of onychomycosis of the toenail.
Measured: 48 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Jan 2013

First posted22 Jul 2011 (estimated)
Study startJul 2011
Primary completionJan 2013
Study completionJan 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 182 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01400594
Sponsor's protocol ID: HTU-520-US01
Status last verified: May 2015
First submitted: 20 Jul 2011
Last updated: 4 Jun 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
Not yet recruiting
Systemic Antifungal Plus Q-Switched Nd:YAG Laser for Onychomycosis
Onychomycosis
Active, not recruitingPhase 1
Photodynamic Therapy For Onychomycosis
Onychomycosis of Toenail
Recruiting
URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
Onychomycosis of Toenail
Active, not recruiting
Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis
Onychomycosis of Toenails, Onychomycosis of Fingernail

All Onychomycosis trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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 Toenail
ClinicalTrials.gov ID: NCT01400594
Acronym / sponsor ID: HTU-520-US01
Conditions: Onychomycosis
Keywords: Onychomycosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 182 participants (actual)
Lead sponsor: Hisamitsu Pharmaceutical Co., Inc.Industry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 22 Jul 2011 (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.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
HTU-520 Patch	Experimental	Drug: HTU-520 PatchSubjects will receive HTU-520 patch in a 1:1 ratio for 48 weeks applied to all toenails.
Placebo Patch	Placebo comparator	Other: Placebo PatchSubjects will receive placebo patch in a 1:1 ratio for 48 weeks applied to all toenails.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (10 listed)

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

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
HTU-520 PatchAlso: HTU-520Terbinafine hydrochloride patch	Drug	HTU-520 Patch
Placebo PatchAlso: Sham treatmentTreatment with Placebo Patch	Other	Placebo Patch

Primary outcome

Determination of status with respect to complete cure (mycological cure together with clinical cure) of onychomycosis of the toenail.
Time frame: 48 Weeks

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 4 Jun 2015.

Related trials for Onychomycosis

RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
Not yet recruiting
Systemic Antifungal Plus Q-Switched Nd:YAG Laser for Onychomycosis
Onychomycosis
Active, not recruitingPhase 1
Photodynamic Therapy For Onychomycosis
Onychomycosis of Toenail
Recruiting
URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
Onychomycosis of Toenail
Active, not recruiting
Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis
Onychomycosis of Toenails, Onychomycosis of Fingernail

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.

Donald Sislen, MD principal investigator

Susan Taylor, MD principal investigator

Melanic Appell, MD principal investigator

37 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HTU-520 Patch in people with Onychomycosis, run by Hisamitsu Pharmaceutical Co., Inc. at 37 sites in United States.

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 7 inclusion and 10 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 4 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Determination of status with respect to complete cure (mycological cure together with clinical cure) of onychomycosis of the toenail. (time frame: 48 Weeks). 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 NCT01400594.

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 4 Jun 2015.