Distal, Subungual OnychomycosisPhase 2NCT00679965
Study of Different Doses of a Novel Treatment for Onychomycosis
A Phase 2 study testing AN2690, 2.5%, AN2690, 5% and AN2690, 7.5% in people with Distal, Subungual Onychomycosis, run by Pfizer at 9 sites in Mexico.
Trial summary
The purpose of the study is to determine the safety and efficacy of 2.5%, 5.0%, and 7.5% AN2690 Solutions compared to the vehicle alone 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
- Distal, Subungual Onychomycosis
- What is being tested?
- AN2690, 2.5%, AN2690, 5% and AN2690, 7.5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 9 sitesMexico
- Study dates
- 28 Feb 2006to 31 Jul 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.
- Male or female subjects of any race at least 18 years of age but not older than 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 a dermatophyte.
- Onychomycosis involving 20-60% of the affected great toenail as determined at baseline (Day 1) 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 dermatophyte: 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
9 sites in 1 country.
9 sites in 1 country
Mexico9 sites
Unidad de Investigación en Salud (UIS)
Chihuahua City
Hospital "Dr. Angel Leaño"
Guadalajara
Instituto Dermatologico Jalisciense
Guadalajara
Centro Dermatologico Pascua
Mexico City
CIF-BIOTEC Medica Sur.
Mexico City
IMIC
Mexico City
Hospital Universitario Dr. José Eleuterio González
Monterrey
MIRC / OCA Hospital
Monterrey
ISSEMYM
Toluca
About this study
Official title: A Randomized, Double-Blind, Vehicle-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Topically Applied AN2690 2.5%, 5.0%, and 7.5% Solutions vs. Vehicle 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 2.5%, 5.0%, and 7.5% AN2690 Solutions compared to the vehicle alone in the treatment of distal, subungual onychomycosis of the great target toenail.
Read the detailed description
The intent is for all subjects to complete a 180 day treatment period consisting of 90 consecutive days of once daily treatment with their assigned study treatment followed by an additional 90 days of three times weekly dosing, even if the treated toenail(s) is evaluated as a "complete responder" prior to the end of treatment 180 day treatment period.
At the end of the 180-Day treatment period, subjects who remain in the study will be classified as complete responders, partial responders, or non-responders. All complete or partial responders will continue to be followed for an additional 180 days until the last evaluation for inclusion in the final analysis.
Periodic efficacy and local tolerance evaluations of the test medication will be performed of the target great toenail and all other treated toenails. KOH wet mounts and fungal cultures from the treatment-targeted great toenail will be performed on the same schedule.
Subjects will also be queried for adverse events and evaluated for application site reactions. Clinical laboratory assessment for safety will be made at Screening, periodically throughout the study, and upon premature discontinuation from the study.
- Conditions
- Distal, Subungual Onychomycosis
- Being tested
- AN2690, 2.5%, AN2690, 5%, AN2690, 7.5%, AN2690 Solution Vehicle
- 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, 2.5%Drug
Once daily application for 90 days and 3 x weekly for 90 days
AN2690, 5%Drug
Once daily application for 90 days and 3 x weekly for 90 days
AN2690, 7.5%Drug
Once daily application for 90 days and 3 x weekly for 90 days
AN2690 Solution VehicleDrug
Once daily application for 90 days and 3x weekly for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | AN2690 Solution, 2.5% Receives: Drug: AN2690, 2.5% |
| Group 2 | Experimental | AN2690 Solution: 5% Receives: Drug: AN2690, 5% |
| Group 3 | Experimental | AN2690 Solution, 7.5% Receives: Drug: AN2690, 7.5% |
| Group 4 | Placebo comparator | AN2690 Solution Vehicle Receives: Drug: AN2690 Solution Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evidence of complete great toenail clearance or at least fungal-clear great toenail growth ("complete" = 5mm; "partial" = 2mm), plus a negative fungal culture from the treatment-targeted great toenail.
Measured: Day 180
Secondary outcomes (1)
Absence of signs and symptoms of onychomycosis plus a negative fungal culture & negative KOH from the treatment-targeted toenail.
Measured: Day 360
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 start28 Feb 2006
- Primary completion31 Jul 2007
- Study completion31 Jul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal, Subungual 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
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 159 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
- NCT00679965
- Sponsor's protocol ID
- AN2690-ONYC-200
- Other IDs
- C3371001
- Status last verified
- Dec 2018
- First submitted
- 15 May 2008
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Vehicle-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Topically Applied AN2690 2.5%, 5.0%, and 7.5% Solutions vs. Vehicle for the Treatment of Adult Subjects With Onychomycosis of the Great Toenail
- ClinicalTrials.gov ID
- NCT00679965
- Acronym / sponsor ID
- AN2690-ONYC-200
- Conditions
- Distal, Subungual Onychomycosis
- Keywords
- Onychomycosis, Fungal Nail
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2006 (actual)
- Primary completion
- 31 Jul 2007 (actual)
- Study completion
- 31 Jul 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 2.5%, 5.0%, and 7.5% AN2690 Solutions compared to the vehicle alone in the treatment of distal, subungual onychomycosis of the great target toenail.
Detailed description
The intent is for all subjects to complete a 180 day treatment period consisting of 90 consecutive days of once daily treatment with their assigned study treatment followed by an additional 90 days of three times weekly dosing, even if the treated toenail(s) is evaluated as a "complete responder" prior to the end of treatment 180 day treatment period.
At the end of the 180-Day treatment period, subjects who remain in the study will be classified as complete responders, partial responders, or non-responders. All complete or partial responders will continue to be followed for an additional 180 days until the last evaluation for inclusion in the final analysis.
Periodic efficacy and local tolerance evaluations of the test medication will be performed of the target great toenail and all other treated toenails. KOH wet mounts and fungal cultures from the treatment-targeted great toenail will be performed on the same schedule.
Subjects will also be queried for adverse events and evaluated for application site reactions. Clinical laboratory assessment for safety will be made at Screening, periodically throughout the study, and upon premature discontinuation from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: AN2690, 2.5%AN2690 Solution, 2.5% |
| Group 2 | Experimental | Drug: AN2690, 5%AN2690 Solution: 5% |
| Group 3 | Experimental | Drug: AN2690, 7.5%AN2690 Solution, 7.5% |
| Group 4 | Placebo comparator | Drug: AN2690 Solution VehicleAN2690 Solution Vehicle |
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.
- Male or female subjects of any race at least 18 years of age but not older than 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 a dermatophyte.
- Onychomycosis involving 20-60% of the affected great toenail as determined at baseline (Day 1) 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.
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, 2.5%Once daily application for 90 days and 3 x weekly for 90 days | Drug | Group 1 |
| AN2690, 5%Once daily application for 90 days and 3 x weekly for 90 days | Drug | Group 2 |
| AN2690, 7.5%Once daily application for 90 days and 3 x weekly for 90 days | Drug | Group 3 |
| AN2690 Solution VehicleOnce daily application for 90 days and 3x weekly for 90 days | Drug | Group 4 |
Primary outcome
Clinical evidence of complete great toenail clearance or at least fungal-clear great toenail growth ("complete" = 5mm; "partial" = 2mm), plus a negative fungal culture from the treatment-targeted great toenail.
Time frame: Day 180
1 secondary outcome
Absence of signs and symptoms of onychomycosis plus a negative fungal culture & negative KOH from the treatment-targeted toenail.
Time frame: Day 360
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 12 Dec 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
9 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, 2.5%, AN2690, 5% and AN2690, 7.5% in people with Distal, Subungual Onychomycosis, run by Pfizer at 9 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 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 12 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 9 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?
Clinical evidence of complete great toenail clearance or at least fungal-clear great toenail growth ("complete" = 5mm; "partial" = 2mm), plus a negative fungal culture from the treatment-targeted great toenail. (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 12 Dec 2018.