OnychomycosisPhase 2NCT00680134
Safety and Efficacy Evaluation of Topically Applied AN2690 Solutions for Subjects With Onychomycosis
A Phase 2 study testing AN2690 in people with Onychomycosis, run by Pfizer at 7 sites in United States.
Trial summary
The purpose of the study is to determine the safety and efficacy of 1% and 5% AN2690 solutions in the treatment of distal, subungual onychomycosis of the great toenail. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- AN2690
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 Jun 2006to 31 Aug 2007
- 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
- Witnessed, signed informed consent approved by Institutional Review Board/Ethics Committee
- A signed Health Insurance Portability and Accountability Act (HIPAA) authorization form which permits the use and disclosure of subject's individually identifiable health information for those enrolled in the United States of America
- Male or female subjects of any race 18 -65 years of age
- Subjects with a diagnosis of onychomycosis of at least one great toenail and with a positive KOH wet mount and a positive fungal culture for dermatophyte species
- Onychomycosis involving 20-60% of the affected great toenail as determined at baseline (Day1) by visual inspection after the nail has been trimmed
- The combined thickness of the distal nail plate and the associated hyperkeratotic nail bed <3 mm
- Affected great toenail to be treated is capable of re-growth as documented by history or recent observation of at least 2 mm of growth
Who cannot join
- Females of childbearing potential not using a highly effective method of birth control (e.g. implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices) during the study
- Subjects unwilling to refrain from the use of nail cosmetics such as clear and or colored nail lacquers from the screening visit until the end of the study
- Subjects with chronic moccasin type of T. pedis
- Subjects with a history of having failed any previous topical antifungal therapy for their onychomycosis
- Diabetes mellitus requiring treatment other than diet and exercise
- Subjects that have not undergone the specified washout period(s) for the following topical preparations or subjects who require the concurrent use of any of the following topical medications:
Show all 22Show fewer
- Topical antifungal applied to toenails (does not include antifungals for treatment of T. pedis): 12 weeks
- Anti-inflammatories, corticosteroids, topical immunomodulators (in the treatment area): 2 weeks
- Subjects that have not undergone the specified washout period(s) for the following systemic medications or subjects who require the concurrent use of any of the following systemic medications:
- Corticosteroids (including intramuscular injections): 2 weeks
- Antifungals for treatment of onychomycosis or any systemic antifungal with known activity against dermatophyte species: 24 weeks
- Systemic immunomodulators: 4 weeks
- Treatment of any type for cancer within the last 6 months
- History of any significant internal disease
- Subjects with a medical history of current or past psoriasis of the skin and/or nails
- Concurrent lichen planus
- Subjects who are known to be allergic to any of the test product(s) or any components in the test product(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure
- Nail or anatomic abnormalities of the toe, e.g., genetic nail disorders, primentary disorders, onychogryphosis, trauma to the nail(s) to be treated
- AIDS or AIDS related complex
- History of street drug or alcohol abuse
- Any subject not able to meet the study attendance requirements
- Subjects who have participated in any other trial of an investigational drug or device within 60 days prior to enrollment or participation in a research study concurrent with this study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
DermResearch, Inc.
Austin, Texas, 78759
University of Alabama at Birmingham
Birmingham, Alabama, 35233
J&S Studies
Bryan, Texas, 77802
Columbia University Medical Center
New York, New York, 10032
Endeavor Clinical Trials, PA & San Antonio Podiatry Associates, PC
San Antonio, Texas, 78229
University of California, San Francisco
San Francisco, California, 94143-0517
About this study
Official title: An Open Label, Multi-center Study To Evaluate The Safety And Efficacy Of Topically Applied An2690 1% And 5% Solutions For The Treatment Of Adult Subjects With Onychomycosis Of The Great Toenail
The purpose of the study is to determine the safety and efficacy of 1% and 5% AN2690 solutions in the treatment of distal, subungual onychomycosis of the great toenail.
Read the detailed description
The first group of 30 protocol-qualified subjects will be assigned to Treatment Group 1 and given 1% AN2690 Solution. The second group of 30 protocol-qualified subjects will be assigned to Treatment Group 2 and given 5% AN2690 Solution.
- Conditions
- Onychomycosis
- Being tested
- AN2690
- Keywords
- Onychomycosis, Fungal Nail
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AN2690Drug
AN2690 1% Solution, once daily for 180 days
AN2690Drug
AN2690 5% Solution, once daily for 30 days; 3x weekly for 150 days
| Study group | Role | What they receive |
|---|---|---|
| Group/Cohort 1 | Experimental | AN2690 1% Solution (30 subjects) Receives: Drug: AN2690 |
| Group/Cohort 2 | Experimental | AN2690 5% Solution (30 subjects) Receives: Drug: AN2690 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete or partial clinical evidence of great toenail clearance or at least 2 mm of fungal clear linear great toenail growth plus a negative fungal culture from the treatment targeted toenail at the End-of-treatment (Day 180)
Measured: Day 180
Secondary outcomes (1)
Evaluations of mycological response, changes from baseline linear toenail growth, proportion of subjects who are successful "Complete Responders"
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2008 (estimated)
- Study start30 Jun 2006
- Primary completion31 Aug 2007
- Study completion31 Aug 2007
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.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680134
- Sponsor's protocol ID
- AN2690-ONYC-203
- Other IDs
- C3371007
- Status last verified
- Feb 2018
- First submitted
- 15 May 2008
- Last updated
- 20 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multi-center Study To Evaluate The Safety And Efficacy Of Topically Applied An2690 1% And 5% Solutions For The Treatment Of Adult Subjects With Onychomycosis Of The Great Toenail
- ClinicalTrials.gov ID
- NCT00680134
- Acronym / sponsor ID
- AN2690-ONYC-203
- Conditions
- Onychomycosis
- Keywords
- Onychomycosis, Fungal Nail
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2006 (actual)
- Primary completion
- 31 Aug 2007 (actual)
- Study completion
- 31 Aug 2007 (actual)
- First posted
- 19 May 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 the study is to determine the safety and efficacy of 1% and 5% AN2690 solutions in the treatment of distal, subungual onychomycosis of the great toenail.
Detailed description
The first group of 30 protocol-qualified subjects will be assigned to Treatment Group 1 and given 1% AN2690 Solution. The second group of 30 protocol-qualified subjects will be assigned to Treatment Group 2 and given 5% AN2690 Solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group/Cohort 1 | Experimental | Drug: AN2690AN2690 1% Solution (30 subjects) |
| Group/Cohort 2 | Experimental | Drug: AN2690AN2690 5% Solution (30 subjects) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Witnessed, signed informed consent approved by Institutional Review Board/Ethics Committee
- A signed Health Insurance Portability and Accountability Act (HIPAA) authorization form which permits the use and disclosure of subject's individually identifiable health information for those enrolled in the United States of America
- Male or female subjects of any race 18 -65 years of age
- Subjects with a diagnosis of onychomycosis of at least one great toenail and with a positive KOH wet mount and a positive fungal culture for dermatophyte species
- Onychomycosis involving 20-60% of the affected great toenail as determined at baseline (Day1) by visual inspection after the nail has been trimmed
Key exclusion criteria (22 listed)
- Females of childbearing potential not using a highly effective method of birth control (e.g. implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices) during the study
- Subjects unwilling to refrain from the use of nail cosmetics such as clear and or colored nail lacquers from the screening visit until the end of the study
- Subjects with chronic moccasin type of T. pedis
- Subjects with a history of having failed any previous topical antifungal therapy for their onychomycosis
- Diabetes mellitus requiring treatment other than diet and exercise
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 |
|---|---|---|
| AN2690AN2690 1% Solution, once daily for 180 days | Drug | Group/Cohort 1 |
| AN2690AN2690 5% Solution, once daily for 30 days; 3x weekly for 150 days | Drug | Group/Cohort 2 |
Primary outcome
Complete or partial clinical evidence of great toenail clearance or at least 2 mm of fungal clear linear great toenail growth plus a negative fungal culture from the treatment targeted toenail at the End-of-treatment (Day 180)
Time frame: Day 180
1 secondary outcome
Evaluations of mycological response, changes from baseline linear toenail growth, proportion of subjects who are successful "Complete Responders"
Time frame: Day 180
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 20 Feb 2018.
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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.
Pfizer CT.gov Call Center study director
Pfizer
7 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 AN2690 in people with Onychomycosis, run by Pfizer at 7 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 22 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 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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?
Complete or partial clinical evidence of great toenail clearance or at least 2 mm of fungal clear linear great toenail growth plus a negative fungal culture from the treatment targeted toenail at the End-of-treatment (Day 180) (time frame: Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2018.