OnychomycosisPhase 2NCT00453271
Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail
A Phase 2 study testing NB-002 in people with Onychomycosis, run by NanoBio Corporation at 24 sites in 2 countries.
Trial summary
The purpose of the study is to determine whether NB002, 0.25%, and 0.5% are safe and effective in the treatment of distal subungual onychomycosis of the toenail. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Onychomycosis
- What is being tested?
- NB-002
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 443 participants
- Where
- 24 sitesin 2 countries
- Study dates
- Jan 2007to Oct 2008
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- are healthy males or females between the ages of 18 and 75 years of age;
- have a clinical diagnosis of mild to moderate DSO in the nail of at least one great toe, involving 25%-67% of the nail, without lunular or proximal involvement;
- positive mycology results (ie, KOH test and culture of a dermatophyte) from the target great toenail;
- refrain from using any lotions, creams, liquids, or polish on treated toenails or on the skin immediately adjacent to the toenails during the treatment period unless directed to do so by the investigator;
- are willing to refrain from using topical steroids or topical antifungals on toenails or the skin immediately adjacent to the toenails; or systemic antifungals for the duration of the study;
Who cannot join
- females who are pregnant, plan to become pregnant during the study, or are nursing a child;
- are hypersensitive to topical creams, ointments, medications, or surfactants;
- have received systemic antifungal therapy for any reason within 3 months, or topical antifungal therapy on the toenails or skin immediately adjacent to the toenails within 3 weeks prior to the start of the study; or
- have taken any investigational drug within 4 weeks prior to the start of the study.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States13 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
DermResearch Inc.
Austin, Texas, 78759
Northwest Clinical Trial
Boise, Idaho, 83704
J & S Studies, Inc.
Bryan, Texas, 77802
Michigan Center for Research Corp.
Clinton Township, Michigan, 48038
Welborne Clinic
Evansville, Indiana, 47713
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
International Dermatology Research
Miami, Florida, 33144
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
Oregon Dermatology and Research Center
Portland, Oregon, 97210
Oregon Medical Research Center, PC
Portland, Oregon, 97223
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84124
Endeavor Clinical Trials, PA
San Antonio, Texas, 78229
Canada11 sites
Ultranova Skincare
Barrie, Ontario, L4M 6L2
Eastern Canada Cutaneous Research Associates, LTD
Halifax, Nova Scotia, B3H 1A4
The Guenther Dermatology Research Centre
London, Ontario, N6A 3H7
Lynderm Research, Inc.
Markham, Ontario, L3P 1A8
Dermatology Clinic
Mississauga, Ontario, L4Y 1A6
Innovaderm Research, Inc.
Montreal, Quebec, H2K 4L5
International Dermatology Research, Inc.
Montreal, Quebec, H3H 1U4
EntraLogix Clinical Group, Inc.
Oakville, Ontario, L6K1E1
Centre de Reeberche Dermatologique du Quebec Metropolitain (CRDQ)
Québec, Quebec, G1V 4X7
Newlab Clinical Research, Inc.
St. John's, Newfoundland and Labrador, A1B 4S8
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4
About this study
Official title: A Randomized, Double-Blind, Parallel-Group,Multicenter, Dose-Response, Vehicle-Controlled Study of the Safety and Efficacy of NB-002 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail
The purpose of the study is to determine whether NB002, 0.25%, and 0.5% are safe and effective in the treatment of distal subungual onychomycosis of the toenail.
Read the detailed description
The purpose of the study is to determine whether NB002, 0.25%, and 0.5% are safe and effective in the treatment of distal subungual onychomycosis of the toenail.
- Conditions
- Onychomycosis
- Being tested
- NB-002, Vehicle control
- Keywords
- chronic persistent infection of the nail bed or plate
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NB-002Drug
Vehicle controlDrug
| Study group | Role | What they receive |
|---|---|---|
| NB-002 0.25% BID | Experimental | Not described Receives: Drug: NB-002 |
| NB-002 0.5% QD | Experimental | Not described Receives: Drug: NB-002 |
| NB-002 0.5% BID | Experimental | Not described Receives: Drug: NB-002 |
| Vehicle control | Sham comparator | Not described Receives: Drug: Vehicle control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Planimetry assessment of the target great toenail
Measured: Week 24
Rate of complete cure
Measured: Week 46
Rate of therapeutic success
Measured: Week 46
Secondary outcomes (2)
Investigator's visual assessment of length of new unaffected nail
The presence/absence of DSO on all toenails
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2007 (estimated)
- Study startJan 2007
- Primary completionOct 2008
- Study completionOct 2008
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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- NanoBio Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alicia Barba, MD, Principal investigator, International Dermatology Research, Inc.Alicia Bucko, DO, Principal investigator, Academic Dermatology AssociatesRichard Pollak, DPM, MS, Principal investigator, Endeavor Clinical Trials, PAMichael Jarratt, MD, Principal investigator, Derm Research, PLLCTerry Jones, MD, Principal investigator, J & S Studies, Inc.Robert Kaylor, DPM, Principal investigator, Welborne ClinicSteven Kempers, MD, Principal investigator, Minnesota Clinical Study CenterRobert Matheson, MD, Principal investigator, Oregon Medical Research Center, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453271
- Sponsor's protocol ID
- NB-002-002
- Status last verified
- May 2013
- First submitted
- 26 Mar 2007
- Last updated
- 23 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Group,Multicenter, Dose-Response, Vehicle-Controlled Study of the Safety and Efficacy of NB-002 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail
- ClinicalTrials.gov ID
- NCT00453271
- Acronym / sponsor ID
- NB-002-002
- Conditions
- Onychomycosis
- Keywords
- chronic persistent infection of the nail bed or plate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- NanoBio CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 28 Mar 2007 (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 whether NB002, 0.25%, and 0.5% are safe and effective in the treatment of distal subungual onychomycosis of the toenail.
Detailed description
The purpose of the study is to determine whether NB002, 0.25%, and 0.5% are safe and effective in the treatment of distal subungual onychomycosis of the toenail.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NB-002 0.25% BID | Experimental | Drug: NB-002 |
| NB-002 0.5% QD | Experimental | Drug: NB-002 |
| NB-002 0.5% BID | Experimental | Drug: NB-002 |
| Vehicle control | Sham comparator | Drug: Vehicle control |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- are healthy males or females between the ages of 18 and 75 years of age;
- have a clinical diagnosis of mild to moderate DSO in the nail of at least one great toe, involving 25%-67% of the nail, without lunular or proximal involvement;
- positive mycology results (ie, KOH test and culture of a dermatophyte) from the target great toenail;
- refrain from using any lotions, creams, liquids, or polish on treated toenails or on the skin immediately adjacent to the toenails during the treatment period unless directed to do so by the investigator;
- are willing to refrain from using topical steroids or topical antifungals on toenails or the skin immediately adjacent to the toenails; or systemic antifungals for the duration of the study;
Key exclusion criteria (5 listed)
- females who are pregnant, plan to become pregnant during the study, or are nursing a child;
- are hypersensitive to topical creams, ointments, medications, or surfactants;
- have received systemic antifungal therapy for any reason within 3 months, or topical antifungal therapy on the toenails or skin immediately adjacent to the toenails within 3 weeks prior to the start of the study; or
- have taken any investigational drug within 4 weeks prior to the start of the study.
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| NB-002 | Drug | NB-002 0.25% BID, NB-002 0.5% BID, NB-002 0.5% QD |
| Vehicle control | Drug | Vehicle control |
Primary outcome
Planimetry assessment of the target great toenail
Time frame: Week 24
Rate of complete cure
Time frame: Week 46
Rate of therapeutic success
Time frame: Week 46
2 secondary outcomes
Investigator's visual assessment of length of new unaffected nail
The presence/absence of DSO on all toenails
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 23 May 2013.
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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.
Alicia Barba, MD principal investigator
International Dermatology Research, Inc.
Alicia Bucko, DO principal investigator
Academic Dermatology Associates
Richard Pollak, DPM, MS principal investigator
Endeavor Clinical Trials, PA
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NB-002 in people with Onychomycosis, run by NanoBio Corporation at 24 sites in 2 countries.
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 5 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 23 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Canada. 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?
Planimetry assessment of the target great toenail (time frame: Week 24). The study lists 3 primary outcomes in all. 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 23 May 2013.