OnychomycosisPhase 2NCT00680160
Absorption and Systemic Study of AN2690 in Patients With Moderate to Severe Onychomycosis (ADME I)
A Phase 2 study testing AN2690 in people with Onychomycosis, run by Pfizer at 1 site in United States.
Trial summary
The purpose of the study is to determine the absorption, systemic pharmacokinetics and accumulation in the nail of AN2690 during a 28 day period of daily application of a 7.5% solution of AN2690 to all 10 toenails of up to 25 otherwise healthy adult 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?
- AN2690
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2006to 9 May 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
- A witnessed, signed informed consent approved by Institutional Review Board
- Male or female of any race at least 18 years of age but not older than 65 years of age at the time of screening
- Body Mass Index between 18.5 and 35, inclusive
- Onychomycosis involving > 80% of both great toenails, as determined by visual inspection after the nail has been trimmed
- Each great toenail possess a combined thickness of the nail plate and nail bed > 3 mm
- At least six additional toenails with clinical diagnosis of onychomycosis
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- A positive KOH wet mount for at least one great toenail
- If subject is a female of childbearing potential, must be using a highly effective method of birth control (e.g. implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices) during the study
- Considered reliable and capable of understanding his/her responsibility and role in the study
Who cannot join
- History of allergy 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
- Clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety
- Diabetes mellitus requiring treatment other than diet and exercise
- 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
- Nursing, pregnant or planning to become pregnant during the study
- Has not undergone the specified washout period(s) for the following topical preparations or does the subject require the concurrent use of any of the following topical medications:
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- 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
- Has not undergone the specified washout period(s) for the following systemic medications or does the subject 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
- Received treatment of any type for cancer within the last 6 months
- History of any significant internal disease
- 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
- Donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation
- Donated plasma during the two week period preceding study initiation
- 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
1 site in 1 country.
About this study
Official title: An Open-label, Multiple-dose Study Of The Absorption And Systemic Pharmacokinetics Of An2690 Applied As A 7.5% Solution To All Toenails Of Adult Patients With Moderate To Severe Onychomycosis
The purpose of the study is to determine the absorption, systemic pharmacokinetics and accumulation in the nail of AN2690 during a 28 day period of daily application of a 7.5% solution of AN2690 to all 10 toenails of up to 25 otherwise healthy adult patients with onychomycosis.
Read the detailed description
For this study, the case definition of onychomycosis included moderate to severe distal subungual onychomycosis including subjects with evidence of subungual dermatophytoma or yellow spikes, lateral and proximal onychomycosis and severely dystrophic nail plates. Subjects with only superficial white onychomycosis were excluded. Confirmation of the clinical diagnosis of onychomycosis of at least one great toenail included a positive KOH wet mount.
- 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 7.5% Solution, once daily for 28 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy measures of linear toenail growth, fungal culture results, KOH results, and clear toenail
Measured: Days 0, 14, 28, 42, 84, 120, 150, 180, 240, 300, and 360
Secondary outcomes (1)
Safety and tolerance assessed by application site reactions, adverse events, laboratory tests, vital signs, physical examinations, and 12-lead EKG
Measured: Days 0-28, 42, 84, 120, 150, 180, 240, 300, and 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 start30 Apr 2006
- Primary completion9 May 2007
- Study completion9 May 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
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT00680160
- Sponsor's protocol ID
- AN2690-ONYC-202
- Other IDs
- C3371013
- Status last verified
- Feb 2019
- First submitted
- 15 May 2008
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multiple-dose Study Of The Absorption And Systemic Pharmacokinetics Of An2690 Applied As A 7.5% Solution To All Toenails Of Adult Patients With Moderate To Severe Onychomycosis
- ClinicalTrials.gov ID
- NCT00680160
- Acronym / sponsor ID
- AN2690-ONYC-202
- Conditions
- Onychomycosis
- Keywords
- Onychomycosis, Fungal Nail
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2006 (actual)
- Primary completion
- 9 May 2007 (actual)
- Study completion
- 9 May 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 absorption, systemic pharmacokinetics and accumulation in the nail of AN2690 during a 28 day period of daily application of a 7.5% solution of AN2690 to all 10 toenails of up to 25 otherwise healthy adult patients with onychomycosis.
Detailed description
For this study, the case definition of onychomycosis included moderate to severe distal subungual onychomycosis including subjects with evidence of subungual dermatophytoma or yellow spikes, lateral and proximal onychomycosis and severely dystrophic nail plates. Subjects with only superficial white onychomycosis were excluded. Confirmation of the clinical diagnosis of onychomycosis of at least one great toenail included a positive KOH wet mount.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A witnessed, signed informed consent approved by Institutional Review Board
- Male or female of any race at least 18 years of age but not older than 65 years of age at the time of screening
- Body Mass Index between 18.5 and 35, inclusive
- Onychomycosis involving > 80% of both great toenails, as determined by visual inspection after the nail has been trimmed
- Each great toenail possess a combined thickness of the nail plate and nail bed > 3 mm
Key exclusion criteria (20 listed)
- History of allergy 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
- Clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety
- Diabetes mellitus requiring treatment other than diet and exercise
- 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
- Nursing, pregnant or planning to 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 |
|---|---|---|
| AN2690AN2690 7.5% Solution, once daily for 28 days | Drug | – |
Primary outcome
Efficacy measures of linear toenail growth, fungal culture results, KOH results, and clear toenail
Time frame: Days 0, 14, 28, 42, 84, 120, 150, 180, 240, 300, and 360
1 secondary outcome
Safety and tolerance assessed by application site reactions, adverse events, laboratory tests, vital signs, physical examinations, and 12-lead EKG
Time frame: Days 0-28, 42, 84, 120, 150, 180, 240, 300, and 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 21 Feb 2019.
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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
1 site 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 1 site 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 9 inclusion and 20 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 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Efficacy measures of linear toenail growth, fungal culture results, KOH results, and clear toenail (time frame: Days 0, 14, 28, 42, 84, 120, 150, 180, 240, 300, and 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 21 Feb 2019.