Onychomycosis of ToenailsPhase 3NCT01270971

Efficacy and Safety Evaluation of AN2690 Topical Solution to Treat Onychomycosis of the Toenail

A Phase 3 study testing AN2690 Topical Solution, 5% in people with Onychomycosis of Toenails, run by Pfizer at 27 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether AN2690 topical solution is a safe and effective treatment for onychomycosis of the toenail. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Onychomycosis of Toenails
What is being tested?: AN2690 Topical Solution, 5%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 594 participants
Where: 27 sitesUnited States
Study dates: 1 Dec 2010to 8 Jan 2013
Phase: Phase 3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical diagnosis of distal subungual onychomycosis affecting at least one great toenail
KOH positive at screening
Willingness not to use any other products including nail polish applied to the toenails during the study
Women of childbearing potential who are currently sexually active must agree to use contraception for the entire study period

Who cannot join

Concurrent or recent use of certain topical or systemic medications without a sufficient washout period
History of any significant chronic fungal disease other than onychomycosis
Significant confounding conditions as assessed by study doctor
Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
Pregnancy or lactation

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

United States27 sites

Investigational Site
Austin, Texas, 78759
Investigational Site
Baltimore, Maryland, 21214
Investigational Site
Boise, Idaho, 83686
Investigational Site
Burbank, California, 91505
Investigational Site
Cincinnati, Ohio, 45249
Investigational Site
College Station, Texas, 77845
Investigational Site
Denver, Colorado, 80210
Investigational Site
Evansville, Indiana, 47713
Investigational Site
Fridley, Minnesota, 55432
Investigational Site
Germantown, Tennessee, 38138
Investigational Site
Hot Springs, Arkansas, 71913
Investigational Site
Los Angeles, California, 90045
Investigational Site
Lynchburg, Virginia, 24501
Investigational Site
New York, New York, 10011
Investigational Site
New York, New York, 10155
Investigational Site
Omaha, Nebraska, 68144
Investigational Site
Orange Park, Florida, 32073
Investigational Site
Overland Park, Kansas, 66202
Investigational Site
Portland, Oregon, 97210
Investigational Site
Providence, Rhode Island, 02920
Investigational Site
Rochester, New York, 14623
Investigational Site
San Antonio, Texas, 78229
Investigational Site
San Francisco, California, 94115
Investigational Site
South Euclid, Ohio, 44118
Investigational Site
Spokane, Washington, 99204
Investigational Site
Tucson, Arizona, 85741
Investigational Site
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Vehicle-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of AN2690 Topical Solution, 5%, vs. Solution Vehicle in the Treatment of Onychomycosis of the Toenail in Adults

The purpose of this study is to determine whether AN2690 topical solution is a safe and effective treatment for onychomycosis of the toenail.

Conditions: Onychomycosis of Toenails
Being tested: AN2690 Topical Solution, 5%, Solution Vehicle
Keywords: Onychomycosis, nail fungus, toenail fungus, fungal nail, hyperkeratosis, nail infection, nail treatment, toenail infection, toenail treatment, foot dermatoses, fungal culture, onycholysis, podiatrist, podiatry, subungual, tinea unguium, antifungal, anti-fungal, dermatologist, dermatology
Medical subject headings: Onychomycosis, Keratoderma, Palmoplantar, Epidermolytic, Foot Dermatoses, Onycholysis, Yellow Nail Syndrome, Nails, Malformed, Twenty-Nail Dystrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AN2690 Topical Solution, 5%Drug
AN2690 Topical Solution, 5%, applied once daily for 48 weeks
Solution VehicleDrug
AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks

Study groups in NCT01270971
Study group	Role	What they receive
AN2690 Topical Solution, 5%	Experimental	AN2690 Topical Solution, 5% Receives: Drug: AN2690 Topical Solution, 5%
Solution Vehicle	Placebo comparator	Solution Vehicle Receives: Drug: Solution Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52
No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.
Measured: Week 52

Secondary outcomes (3)

Completely Clear or Almost Clear Target Great Toenail at Week 52
No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis.
Measured: Week 52
Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52
No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.
Measured: Week 52
Negative Mycology of Target Great Toenail at Week 52
Negative KOH and negative fungal culture.
Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20108 Jan 2013

First posted6 Jan 2011 (estimated)
Study start1 Dec 2010
Primary completion30 Nov 2012
Study completion8 Jan 2013

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 Onychomycosis of ToenailsStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 594 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01270971
Sponsor's protocol ID: AN2690-ONYC-301
Status last verified: Feb 2019
First submitted: 3 Jan 2011
Last updated: 22 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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
Active, not recruitingPhase 2
Safety, Tolerability and Efficacy of Trichostatin A in Patients With Mild to Severe Onychomycosis
Onychomycosis of Toenail
Not yet recruitingPhase 2
A Phase 2 Study to Assess the Effectiveness of Topical Terbinafine in Participants With Mild to Moderate Onychomycosis of the Toenails
Onychomycosis of Toenail

All Onychomycosis of Toenails trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2019. 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 Efficacy and Safety of AN2690 Topical Solution, 5%, vs. Solution Vehicle in the Treatment of Onychomycosis of the Toenail in Adults
ClinicalTrials.gov ID: NCT01270971
Acronym / sponsor ID: AN2690-ONYC-301
Conditions: Onychomycosis of Toenails
Keywords: Onychomycosis, nail fungus, toenail fungus, fungal nail, hyperkeratosis, nail infection, nail treatment, toenail infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 594 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 1 Dec 2010 (actual)
Primary completion: 30 Nov 2012 (actual)
Study completion: 8 Jan 2013 (actual)
First posted: 6 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 this study is to determine whether AN2690 topical solution is a safe and effective treatment for onychomycosis of the toenail.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
AN2690 Topical Solution, 5%	Experimental	Drug: AN2690 Topical Solution, 5%AN2690 Topical Solution, 5%
Solution Vehicle	Placebo comparator	Drug: Solution VehicleSolution Vehicle

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Clinical diagnosis of distal subungual onychomycosis affecting at least one great toenail
KOH positive at screening
Willingness not to use any other products including nail polish applied to the toenails during the study
Women of childbearing potential who are currently sexually active must agree to use contraception for the entire study period

Key exclusion criteria (5 listed)

Concurrent or recent use of certain topical or systemic medications without a sufficient washout period
History of any significant chronic fungal disease other than onychomycosis
Significant confounding conditions as assessed by study doctor
Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
Pregnancy or lactation

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 Topical Solution, 5%AN2690 Topical Solution, 5%, applied once daily for 48 weeks	Drug	AN2690 Topical Solution, 5%
Solution VehicleAN2690 Topical Solution, Vehicle, applied once daily for 48 weeks	Drug	Solution Vehicle

Primary outcome

Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52
Time frame: Week 52
No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.

3 secondary outcomes

Completely Clear or Almost Clear Target Great Toenail at Week 52
Time frame: Week 52
Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52
Time frame: Week 52
Negative Mycology of Target Great Toenail at Week 52
Time frame: Week 52

Results and safety

Results posted to the registry on 15 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AN2690 Topical Solution, 5%	400	348
Solution Vehicle	194	171

Primary outcome: Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52

Time frame: Week 52. Number. Unit: participants

Measure	AN2690 Topical Solution, 5% n = 399	Solution Vehicle n = 194
Success	26	1
Failure	373	193

AN2690 Topical Solution, 5% vs Solution Vehicle: p = 0.001, Cochran-Mantel-Haenszel

Population analysed: Efficacy analysis was performed using the ITT population. The last observation was carried forward (LOCF) in order to provide a value for efficacy parameters that were missing.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Week 52. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AN2690 Topical Solution, 5%	12 of 396 (3%)	90 of 396 (22.7%)	Not reported
Solution Vehicle	8 of 193 (4.1%)	57 of 193 (29.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Onychomycosis of Toenails

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
Active, not recruitingPhase 2
Safety, Tolerability and Efficacy of Trichostatin A in Patients With Mild to Severe Onychomycosis
Onychomycosis of Toenail
Not yet recruitingPhase 2
A Phase 2 Study to Assess the Effectiveness of Topical Terbinafine in Participants With Mild to Moderate Onychomycosis of the Toenails
Onychomycosis of Toenail

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.

PfizerCT.gov Call Center study director

Pfizer

27 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AN2690 Topical Solution, 5% in people with Onychomycosis of Toenails, run by Pfizer at 27 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 4 inclusion and 5 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 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 27 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52 (time frame: Week 52). 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 NCT01270971.

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 Feb 2019.