OnychomycosisPhase 3NCT01008033
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 72 sites in 3 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
- 870 participants
- Where
- 72 sitesin 3 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
72 sites in 3 countries.
72 sites in 3 countries
United States33 sites
Academic Dermatology
Albuquerque, New Mexico, 87106
Foot and Ankle Associates of Florida, Inc
Altamonte Springs, Florida, 32701
Augusta Centre for Dermatology and Skin Renewal, LLC
Augusta, Georgia, 30909
Austin Dermatology Associates
Austin, Texas, 78705
University of Alabama, Birmingham
Birmingham, Alabama, 35233
Northwest Clinical Trials
Boise, Idaho, 83704
Radiant Research
Cinncinati, Ohio, 45249
Michigan Center for Research Corp.
Clinton Township, Michigan, 48038
J & S Studies, Inc.
College Station, Texas, 77845
Baylor Research Institute
Dallas, Texas, 75246
Hudson Dermatology
Evansville, Indiana, 47714
Rivergate Dermatology
Goodlettsville, Tennessee, 37072
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina, 29607
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Longmont Medical Research Network
Longmont, Colorado, 80501
Dermatology Specialists
Louisville, Kentucky, 40202
The Education and Research Foundation, Inc.
Lynchburg, Virginia, 24501
International Dermatology Research, Inc.
Miami, Florida, 33144
Aurora Advanced Healthcare, Inc. - Clinical Research Center
Milwaukee, Wisconsin, 53209
The Savin Center, PC
New Haven, Connecticut, 06511
Impact Clinical Trials
New Hyde Park, New York, 11040
Virginia Clinical Research, Inc
Norfolk, Virginia, 23507
Ameriderm Research
Ormond Beach, Florida, 32174
Temple University School of Podiatric Medicine
Philadelphia, Pennsylvania, 19107
HOPE Research Institute
Phoenix, Arizona, 85050
Oregon Dermatology and Research Center
Portland, Oregon, 97219
Dermatology Resarch Center
Salt Lake City, Utah, 84124
Stephen Miller, MD, PA
San Antonio, Texas, 78229
Therapeutics Clinical Research
San Diego, California, 92123
University Clinical Trials, Inc
San Diego, California, 92123
University of California, San Francisco
San Francisco, California, 94115
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia, 30078
Haber Dermatology & Cosmetic Surgery
South Euclid, Ohio, 44118
Japan32 sites
Kaken Investigational Site
Dazaifu, Fukuoka
Kaken Investigational Site - Chuo-ku #1
Fukuoka, Fukuoka
Kaken Investigational Site - Chuo-ku #2
Fukuoka, Fukuoka
Kaken Investigational Site - Higashi-ku
Fukuoka, Fukuoka
Kaken Investigational Site - Minami-ku #1
Fukuoka, Fukuoka
Kaken Investigational Site - Minami-ku #2
Fukuoka, Fukuoka
Kaken Investigational Site
Ginowan, Okinawa
Kaken Investigational Site
Itoshima, Fukuoka
Kaken Investigational Site
Kawaguchi, Saitama
Kaken Investigational Site
Kawasaki, Kanagawa
Kaken Investigational Site
Nagasaki, Nagasaki
Kaken Investigational Site
Naha, Okinawa
Kaken Investigational Site
Nakagami, Okinawa
Kaken Investigational Site - Nakano-ku #1
Nakano-ku, Tokyo
Kaken Investigational Site - Nakano-ku #2
Nakano-ku, Tokyo
Kaken Investigational Site - Okinawa #1
Okinawa, Okinawa
Kaken Investigational Site - Okinawa #2
Okinawa, Okinawa
Kaken Investigational Site - Atsubetsu-ku #1
Sapporo, Hokkaido
Kaken Investigational Site - Atsubetsu-ku #2
Sapporo, Hokkaido
Kaken Investigational Site - Atsubetsu-ku #3
Sapporo, Hokkaido
Kaken Investigational Site - Chuo-ku
Sapporo, Hokkaido
Kaken Investigational Site - Kita-ku
Sapporo, Hokkaido
Kaken Investigational Site - Kiyota-ku
Sapporo, Hokkaido
Kaken Investigational Site - Nishi-ku
Sapporo, Hokkaido
Kaken Investigational Site - Shiroishi-ku
Sapporo, Hokkaido
Kaken Investigational Site - Teine-ku #1
Sapporo, Hokkaido
Kaken Investigational Site - Teine-ku #2
Sapporo, Hokkaido
Kaken Investigational Site - Setagaya-ku #1
Setagaya-ku, Tokyo
Kaken Investigational Site - Setagaya-ku #2
Setagaya-ku, Tokyo
Kaken Investigational Site - Shinagawa-ku #1
Shinagawa-ku, Tokyo
Kaken Investigational Site - Shinagawa-ku #2
Shinagawa-ku, Tokyo
Kaken Investigational Site
Urasoe, Okinawa
Canada7 sites
Ultranova Skincare
Barrie, Ontario, L4M 6L2
Kirk Barber Research
Calgary, Alberta, T2S 3B3
Stratica Medical
Edmonton, Alberta, T5K 1X3
Mediprobe Research
New London, Ontario, N5X 2P1
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7
Centre de Recherche Dermatologique du Québec Métropolitain
Québec, Quebec, G1V 4X7
XLR8 Medical Research
Windsor, Ontario, N8W 1E6
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 posted5 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionNov 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
- 870 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
- NCT01008033
- Sponsor's protocol ID
- DPSI-IDP-108-P3-01
- Status last verified
- Jun 2012
- First submitted
- 3 Nov 2009
- Last updated
- 22 Jun 2012
- Results posted
- 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
- Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis
- ClinicalTrials.gov ID
- NCT01008033
- Acronym / sponsor ID
- DPSI-IDP-108-P3-01
- Conditions
- Onychomycosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 870 participants (actual)
- Lead sponsor
- Dow Pharmaceutical SciencesIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 5 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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In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
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Systemic Antifungal Plus Q-Switched Nd:YAG Laser for Onychomycosis
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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.
72 sites in 3 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 72 sites in 3 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 72 sites in United States, Japan, 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 NCT01008033, 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.