OnychomycosisPhase 2NCT00777868
A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-108 in Patients With Onychomycosis
A Phase 2 study testing Low Strength IDP-108, High Strength IDP-108 and High Strength IDP-108 under occlusion in people with Onychomycosis, run by Dow Pharmaceutical Sciences at 10 sites in Mexico.
Trial summary
The purpose of this study is to assess the safety and effectiveness of two concentrations of IDP-108 in treating patients with onychomycosis Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- Low Strength IDP-108, High Strength IDP-108 and High Strength IDP-108 under occlusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 10 sitesMexico
- Study dates
- Oct 2007to Apr 2009
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of onychomycosis of the target toenail
- A positive fungal culture from the target toenail
Who cannot join
- Any disease or condition that might cause nail abnormalities or may interfere with clinical evaluations
- Presence of tinea pedis (athletes foot)
- Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Mexico10 sites
Unidad de Investigación en Salud
Chihuahua City, Chihuahua, CP31205
Instituto Dermatólogico de Jalisco "Dr. Jose Barba Rubio"
Guadalajara, Jalisco, CP45190
Hospital General de México
México, Federal District, CP 06726
Clinical Research Institute
Mexico City, Federal District, CP54055
Hospital Central Militar
Mexico City, Federal District
MIRC/OCA Hospital
Monterrey, Nuevo León, CP64000
Centro de Dermatología de Monterrey
Monterrey, Nuevo León, CP64460
Hospital Universitario "José E. González"
Monterrey, Nuevo León, CP64460
Hospital Ignacio Morones Prieto SLP
San Luis Potosí City, San Luis Potosí, CP 78240
Hospital Dr. Ángel Leaño
Zapopan, Jalisco, CP45200
About this study
The purpose of this study is to assess the safety and effectiveness of two concentrations of IDP-108 in treating patients with onychomycosis
- Conditions
- Onychomycosis
- Being tested
- Low Strength IDP-108, High Strength IDP-108, High Strength IDP-108 under occlusion, Vehicle
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Strength IDP-108Drug
Topical application once a day for 9 months
High Strength IDP-108Drug
Topical application once a day for 9 months
High Strength IDP-108 under occlusionDrug
Topical application once a day for 9 months
VehicleDrug
Topical application once a day for 9 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Low Strength IDP-108 |
| 2 | Experimental | Not described Receives: Drug: High Strength IDP-108 |
| 3 | Experimental | Not described Receives: Drug: High Strength IDP-108 under occlusion |
| 4 | Placebo comparator | Not described Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in area of infected nail
Measured: 9 months
Secondary outcomes (1)
Change from baseline in mycological results
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startOct 2007
- Primary completionApr 2009
- Study completionApr 2009
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 135 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
- NCT00777868
- Sponsor's protocol ID
- DPSI-IDP-108-P2-01
- Status last verified
- Jun 2012
- First submitted
- 20 Oct 2008
- Last updated
- 22 Jun 2012
- Results posted
- No
Publications
Tschen EH, Bucko AD, Oizumi N, Kawabata H, Olin JT, Pillai R. Efinaconazole solution in the treatment of toenail onychomycosis: a phase 2, multicenter, randomized, double-blind study. J Drugs Dermatol. 2013 Feb;12(2):186-92.
PubMed 23377392
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
- A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-108 in Patients With Onychomycosis
- ClinicalTrials.gov ID
- NCT00777868
- Acronym / sponsor ID
- DPSI-IDP-108-P2-01
- Conditions
- Onychomycosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Dow Pharmaceutical SciencesIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 22 Oct 2008 (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 assess the safety and effectiveness of two concentrations of IDP-108 in treating patients with onychomycosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Low Strength IDP-108 |
| 2 | Experimental | Drug: High Strength IDP-108 |
| 3 | Experimental | Drug: High Strength IDP-108 under occlusion |
| 4 | Placebo comparator | Drug: Vehicle |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presence of onychomycosis of the target toenail
- A positive fungal culture from the target toenail
Key exclusion criteria (3 listed)
- Any disease or condition that might cause nail abnormalities or may interfere with clinical evaluations
- Presence of tinea pedis (athletes foot)
- Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study
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 |
|---|---|---|
| Low Strength IDP-108Topical application once a day for 9 months | Drug | 1 |
| High Strength IDP-108Topical application once a day for 9 months | Drug | 2 |
| High Strength IDP-108 under occlusionTopical application once a day for 9 months | Drug | 3 |
| VehicleTopical application once a day for 9 months | Drug | 4 |
Primary outcome
Change from baseline in area of infected nail
Time frame: 9 months
1 secondary outcome
Change from baseline in mycological results
Time frame: 9 months
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 23377392Tschen EH, Bucko AD, Oizumi N, Kawabata H, Olin JT, Pillai R. Efinaconazole solution in the treatment of toenail onychomycosis: a phase 2, multicenter, randomized, double-blind study. J Drugs Dermatol. 2013 Feb;12(2):186-92.
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.
The record lists no contact. Use the official record to reach the sponsor.
10 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 Low Strength IDP-108, High Strength IDP-108 and High Strength IDP-108 under occlusion in people with Onychomycosis, run by Dow Pharmaceutical Sciences at 10 sites in Mexico.
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 2 inclusion and 3 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 10 sites in Mexico. 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?
Change from baseline in area of infected nail (time frame: 9 months). 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 NCT00777868, 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.