OnychomycosisPhase 3NCT01007708
The Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis
A Phase 3 study testing IDP-108 in people with Onychomycosis, run by Dow Pharmaceutical Sciences at 44 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of topical application of IDP-108 versus vehicle in treating patients with onychomycosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- IDP-108
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 780 participants
- Where
- 44 sitesin 2 countries
- Study dates
- Nov 2009to Dec 2011
- Phase
- Phase 3
- 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
- Clinically diagnosed onychomycosis of the target nail
- Presence of mild to moderate onychomycosis, defined as 20 - 50% of the area of the target nail being clinically affected
- Has a positive KOH examination from the target nail
- Has a positive dermatophyte culture from the target nail
Who cannot join
- Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug
- Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis
- Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit
- Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period
Trial locations and contacts
44 sites in 2 countries.
44 sites in 2 countries
United States36 sites
David Fivenson, MD, Dermatology, PLLC
Ann Arbor, Michigan, 48103
DermResearch, Inc.
Austin, Texas, 78759
University of North Carolina Hospitals and School of Medicine
Chapel Hill, North Carolina, 27599
Modern Research Associates, PLLC
Dallas, Texas, 75231
Colorado Medical Research Center Inc
Denver, Colorado, 80210
Deaconess Clinic, Inc.
Evansville, Indiana, 47713
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Dermatology East
Germantown, Tennessee, 38138
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
Suzanne Bruce and Associates, PA The Center for Skin Research
Houston, Texas, 77056
Ameriderm Research
Jacksonville, Florida, 32216
Impact Clinical Trials
Los Angeles, California, 90036
Dermatology Research Associates
Los Angeles, California, 90045
Madison Skin & Research, Inc.
Madison, Wisconsin, 53719
FXM Research Corp.
Miami, Florida, 33175
Palmetto Medical Research
Mt. Pleasant, South Carolina, 29464
Northwest Clinical Trials Nampa
Nampa, Idaho, 83687
DuPage Medical Group
Naperville, Illinois, 60563
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Fran E. Cook-Bolden, MD
New York, New York, 10155
MedaPhase Inc.
Newnan, Georgia, 30263
Central Sooner Research
Norman, Oklahoma, 73069
Dermatology Specialists, Inc.
Oceanside, California, 92056
Oregon Medical Center, PC
Portland, Oregon, 97223
Skin Search of Rochester, Inc
Rochester, New York, 14623
Endeavor Clinical Trials, PA
San Antonio, Texas, 78229
Skin Surgery Medical Group, Inc.
San Diego, California, 92117
Center for Clinical Research
San Francisco, California, 94115
Radiant Research
Santa Rosa, California, 95405
South Bend Clinic
South Bend, Indiana, 46617
Premier Clinical Research
Spokane, Washington, 99204
DermResearchCenter of New York, Inc.
Stony Brook, New York, 11790
The Dermatology Group, P.C.
Verona, New Jersey, 07044
Brodell Medical, Inc
Warren, Ohio, 44483-6204
New Hanover Medical Research
Wilmington, North Carolina, 28401
Canada8 sites
Lynderm Research, Inc.
Markham, Ontario, L3P 1A8
The Centre for Dermatology & Cosmetic Surgery
Richmond Hill, Ontario, L4B 1A5
NewLab Clinical Research
St. John's, Newfoundland and Labrador, A1C 2H5
Guildford Dermatology Specialists
Surrey, British Columbia, V3R 6A7
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4
Beatrice Wang, MD
Westmount, Quebec, H3Z S26
Windsor Clinical Research
Windsor, Ontario, N8W 5L7
Dermadvances Research
Winnipeg, Manitoba, R3C 1R4
About this study
The purpose of this study is to evaluate the safety and efficacy of topical application of IDP-108 versus vehicle in treating patients with onychomycosis.
- Conditions
- Onychomycosis
- Being tested
- IDP-108, Vehicle
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDP-108Drug
Topical application once a day for 48 weeks
VehicleDrug
Topical application once a day for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| IDP-108 | Experimental | Not described Receives: Drug: IDP-108 |
| Vehicle | Placebo comparator | Not described Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who achieve clinical cure
Measured: 52 weeks
Secondary outcomes (2)
Percentage of patients who achieve clinical efficacy
Measured: 52 weeks
Percentage of patients who achieve mycologic cure
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 780 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow Pharmaceutical Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007708
- Sponsor's protocol ID
- DPSI-IDP-108-P3-02
- Status last verified
- Jun 2012
- First submitted
- 3 Nov 2009
- Last updated
- 22 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Gupta AK, Elewski BE, Sugarman JL, Ieda C, Kawabata H, Kang R, Pillai R, Olin JT, Watanabe S. The efficacy and safety of efinaconazole 10% solution for treatment of mild to moderate onychomycosis: a pooled analysis of two phase 3 randomized trials. J Drugs Dermatol. 2014 Jul;13(7):815-20.
PubMed 25007364
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis
- ClinicalTrials.gov ID
- NCT01007708
- Acronym / sponsor ID
- DPSI-IDP-108-P3-02
- Conditions
- Onychomycosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 780 participants (actual)
- Lead sponsor
- Dow Pharmaceutical SciencesIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Nov 2009 (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.
The purpose of this study is to evaluate the safety and efficacy of topical application of IDP-108 versus vehicle in treating patients with onychomycosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDP-108 | Experimental | Drug: IDP-108 |
| Vehicle | Placebo comparator | Drug: Vehicle |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinically diagnosed onychomycosis of the target nail
- Presence of mild to moderate onychomycosis, defined as 20 - 50% of the area of the target nail being clinically affected
- Has a positive KOH examination from the target nail
- Has a positive dermatophyte culture from the target nail
Key exclusion criteria (4 listed)
- Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug
- Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis
- Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit
- Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period
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 |
|---|---|---|
| IDP-108Topical application once a day for 48 weeks | Drug | IDP-108 |
| VehicleTopical application once a day for 48 weeks | Drug | Vehicle |
Primary outcome
Percentage of patients who achieve clinical cure
Time frame: 52 weeks
2 secondary outcomes
Percentage of patients who achieve clinical efficacy
Time frame: 52 weeks
Percentage of patients who achieve mycologic cure
Time frame: 52 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 22 Jun 2012.
- Derived from this study: PubMed 25007364Gupta AK, Elewski BE, Sugarman JL, Ieda C, Kawabata H, Kang R, Pillai R, Olin JT, Watanabe S. The efficacy and safety of efinaconazole 10% solution for treatment of mild to moderate onychomycosis: a pooled analysis of two phase 3 randomized trials. J Drugs Dermatol. 2014 Jul;13(7):815-20.
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URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
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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.
The record lists no contact. Use the official record to reach the sponsor.
44 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IDP-108 in people with Onychomycosis, run by Dow Pharmaceutical Sciences at 44 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 4 inclusion and 4 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 22 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Percentage of patients who achieve clinical cure (time frame: 52 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 NCT01007708, which also lists 1 linked publication.
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 22 Jun 2012.