OnychomycosisPhase 2NCT01278394
Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail
A Phase 2 study testing AN2690 Solution, 5.0% in people with Onychomycosis, run by Pfizer at 2 sites in Mexico.
Trial summary
The purpose of the study is to determine the safety and efficacy of 5.0% AN2690 Solution in the treatment of distal, subungual onychomycosis of the great target 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 Solution, 5.0%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesMexico
- Study dates
- Mar 2007to Jul 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects must meet all of the following criteria to be included in the study:
- Witnessed, signed informed consent approved by Ethics Committee.
- Male or female subjects of any race at least 18 years of age but not older than 65 years of age at the time of screening.
- For Cohorts 1 and 2, subjects with a diagnosis of onychomycosis of at least one great toenail and with a positive KOH wet mount from that nail. For Cohort 3, subjects must have a diagnosis of onychomycosis of at least one great toenail and a positive KOH wet mount AND fungal culture from that nail.
- Onychomycosis involving 20-60% of the affected great toenail as determined 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.
- Normal or not clinically significant screening safety labs.
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.
- Diabetes mellitus requiring treatment other than diet and exercise.
- Subjects with chronic moccasin type of T. pedis.
- Subjects with a history of having failed any previous topical antifungal therapy for their onychomycosis.
- 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 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 the feet (does not include antifungals for treatment of T. pedis during the study): 4 weeks
- Anti-inflammatories, corticosteroids, topical immunomodulators: 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 dermatophytes: 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
2 sites in 1 country.
About this study
Official title: An Open-Label, Rising Multiple-Dose, Multi-Center Study to Evaluate the Safety and Efficacy of Topically Applied AN2690 5.0% and 7.5% Solution 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 5.0% AN2690 Solution in the treatment of distal, subungual onychomycosis of the great target toenail.
Read the detailed description
In this cohort, only the targeted great toenail identified at Baseline prior to the commencement of treatment from culture results collected at the Screening visit were evaluated for primary efficacy whereas all treated toenails were evaluated for safety. At each visit, the investigator was asked to make a clinical evaluation of the targeted great nail, marking whether or not they considered the nail to be clear of onychomycosis. This evaluation was the basis for determining whether or not study medication should be dispensed at the visit.
This record includes information only for Cohort 3 (5% solution) of the study. Cohorts 1 and 2, are described in NCT00679523 (7.5% solution). No comparison was made between Cohorts 1\&2 and Cohort 3.
- Conditions
- Onychomycosis
- Being tested
- AN2690 Solution, 5.0%
- 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.
AN2690 Solution, 5.0%Drug
Once daily application for 360 days
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | AN2690 Solution, 5.0% Receives: Drug: AN2690 Solution, 5.0% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Evidence of Complete Clearance of the Treatment-targeted Great Toenail Plus a Negative Fungal Culture at Day 360
Proportion of subjects with a clinical assessment of a clear (completely normal) nail unit plus a negative fungal culture from the treatment-targeted toenail at Day 360.
Measured: Day 360
Secondary outcomes (6)
Clear Nail Growth of the Targeted Toenail
Clear nail was measured on digital images as the distance in millimeters from the proximal nail fold to the proximal limit of the disease as marked by the Investigator. New Clear Nail Growth (CNG) was calculated from the clear nail measurements.
Measured: Day 360
Mycological Evaluations (Negative Potassium Hydroxide (KOH) and Negative Fungal Culture) Compared to Baseline
Number of subjects with negative KOH, and number of subjects with negative fungal cultures.
Measured: Day 90
Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline
Number of subjects with negative KOH, and number of subjects with negative fungal cultures.
Measured: Day 180
Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline
Number of subjects with negative KOH, and number of subjects with negative fungal cultures.
Measured: Day 270
Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline
Number of subjects with negative KOH, and number of subjects with negative fungal cultures.
Measured: Day 360
Length of Time to Clinical Evaluation of Clear or at Least 5 mm of CNG
Length of time to clinical evaluation of clear or at least 5 mm of CNG.
Measured: Baseline to 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startMar 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278394
- Sponsor's protocol ID
- AN2690-ONYC-201
- Other IDs
- AN2690-ONYC-201 Cohort 3, C3371009
- Status last verified
- Nov 2018
- First submitted
- 14 Jan 2011
- Last updated
- 6 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Rising Multiple-Dose, Multi-Center Study to Evaluate the Safety and Efficacy of Topically Applied AN2690 5.0% and 7.5% Solution for the Treatment of Adult Subjects With Onychomycosis of the Great Toenail
- ClinicalTrials.gov ID
- NCT01278394
- Acronym / sponsor ID
- AN2690-ONYC-201
- Conditions
- Onychomycosis
- Keywords
- Onychomycosis, Fungal Nail
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 17 Jan 2011 (estimated)
- Results
- Posted 15 Aug 2014
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 5.0% AN2690 Solution in the treatment of distal, subungual onychomycosis of the great target toenail.
Detailed description
In this cohort, only the targeted great toenail identified at Baseline prior to the commencement of treatment from culture results collected at the Screening visit were evaluated for primary efficacy whereas all treated toenails were evaluated for safety. At each visit, the investigator was asked to make a clinical evaluation of the targeted great nail, marking whether or not they considered the nail to be clear of onychomycosis. This evaluation was the basis for determining whether or not study medication should be dispensed at the visit.
This record includes information only for Cohort 3 (5% solution) of the study. Cohorts 1 and 2, are described in NCT00679523 (7.5% solution). No comparison was made between Cohorts 1\&2 and Cohort 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: AN2690 Solution, 5.0%AN2690 Solution, 5.0% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must meet all of the following criteria to be included in the study:
- Witnessed, signed informed consent approved by Ethics Committee.
- Male or female subjects of any race at least 18 years of age but not older than 65 years of age at the time of screening.
- For Cohorts 1 and 2, subjects with a diagnosis of onychomycosis of at least one great toenail and with a positive KOH wet mount from that nail. For Cohort 3, subjects must have a diagnosis of onychomycosis of at least one great toenail and a positive KOH wet mount AND fungal culture from that nail.
- Onychomycosis involving 20-60% of the affected great toenail as determined 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.
- Diabetes mellitus requiring treatment other than diet and exercise.
- Subjects with chronic moccasin type of T. pedis.
- Subjects with a history of having failed any previous topical antifungal therapy for their onychomycosis.
- 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.
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 |
|---|---|---|
| AN2690 Solution, 5.0%Once daily application for 360 days | Drug | Group 1 |
Primary outcome
Clinical Evidence of Complete Clearance of the Treatment-targeted Great Toenail Plus a Negative Fungal Culture at Day 360
Time frame: Day 360
Proportion of subjects with a clinical assessment of a clear (completely normal) nail unit plus a negative fungal culture from the treatment-targeted toenail at Day 360.
6 secondary outcomes
Clear Nail Growth of the Targeted Toenail
Time frame: Day 360
Mycological Evaluations (Negative Potassium Hydroxide (KOH) and Negative Fungal Culture) Compared to Baseline
Time frame: Day 90
Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline
Time frame: Day 180
Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline
Time frame: Day 270
Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline
Time frame: Day 360
Length of Time to Clinical Evaluation of Clear or at Least 5 mm of CNG
Time frame: Baseline to 360
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
2 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 Solution, 5.0% in people with Onychomycosis, run by Pfizer at 2 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 8 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 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
Yes. Results are posted in the registry (first posted 15 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Evidence of Complete Clearance of the Treatment-targeted Great Toenail Plus a Negative Fungal Culture at Day 360 (time frame: Day 360). 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 6 Dec 2018.