Tinea PedisPhase 3NAFT-600NCT01290341
Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis
A Phase 3 study testing NAFT-600 (naftin 2 % gel) in people with Tinea Pedis, run by Merz North America, Inc. at 23 sites in United States.
Trial summary
This is a 6-week, double-blind, randomized, placebo-controlled, multicenter, parallel group Phase 3 study of NAFT-600 applied once a day for 2 weeks compared to vehicle (placebo) in the treatment of tinea pedis. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Tinea Pedis
- What is being tested?
- NAFT-600 (naftin 2 % gel)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 860 participants
- Where
- 23 sitesUnited States
- Study dates
- Feb 2011to Dec 2011
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males or non-pregnant females, ≥12 years of age, of any race or sex. Females of child-bearing potential must have a negative urine pregnancy test.
- For minors (less than 18 years), the parent/legal guardian must complete the informed consent process AND the subject must complete the assent process and sign the appropriate form (if age appropriate).
- Presence of interdigital only or both interdigital and moccasin types of tinea pedis on one or both feet characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling and mild pruritus) based on signs and symptoms in the affected area(s).
Who cannot join
- Subjects with life-threatening condition (ex. autoimmune deficiency syndrome, cancer, unstable angina or myocardial infarction) within the last 6 months.
- Subjects with abnormal findings - physical or laboratory - that are considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results.
- Subjects with a known hypersensitivity to study drugs or their components.
- Subjects who have a recent history or who are currently known to abuse alcohol or drugs.
- Uncontrolled diabetes mellitus.
- Hemodialysis or chronic ambulatory peritoneal dialysis therapy.
Show all 11Show fewer
- Current diagnosis of immunocompromising conditions.
- Foot psoriasis, corns and/or callus involving any web spaces, atopic or contact dermatitis.
- Severe dermatophytoses, onychomycosis (on the evaluated foot), mucocutaneous candidiasis or bacterial skin infection.
- Extremely severe tinea pedis (incapacitating).
- Female subject who is pregnant or lactating, who is not using or does not agree to use an acceptable form of contraception during the study, or who intends to become pregnant during the study.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
DermResearch, Inc.
Austin, Texas, 78759
Radiant Research, Inc
Cincinnati, Ohio, 45249
Tampa Bay Medical Research
Clearwater, Florida, 33761
J&S Studies, Inc.
College Station, Texas, 77845
Radiant Research, Inc.
Columbus, Ohio, 43212
Research Across America
Dallas, Texas, 75234
Colorado Medical Research Center
Denver, Colorado, 80210
T. Joseph Raoof, MD, Inc.
Encino, California, 91436
Hudson Dermatology
Evansville, Indiana, 47714
Longmont Clinic, PC
Longmont, Colorado, 80501
The Education and Research Foundation, Inc.
Lynchburg, Virginia, 24501
Madison Skin and Research, Inc
Madison, Wisconsin, 53719
Lake Washington Foot and Ankle Center
Melbourne, Florida, 32935
Department of Veterans Affairs
Minneapolis, Minnesota, 55417
Temple University- School of Podiatric Medicine
Philadelphia, Pennsylvania, 19107
Oregon Dermatology & Research Center
Portland, Oregon, 97210
Endeavor Clinical Trials, PA
San Antonio, Texas, 78229
Progressive Clinical Research
San Antonio, Texas, 78229
Walter K. Nahm, MD, PhD, Inc.
San Diego, California, 92123
Palmetto Clinical Trial Services, LLC
Simpsonville, South Carolina, 29681
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Radiant Research, Inc.
Tucson, Arizona, 85710
About this study
Official title: A Phase 3 Double-Blind, Randomized, Placebo-Controlled,Multicenter, Parallel Group Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis
This is a 6-week, double-blind, randomized, placebo-controlled, multicenter, parallel group Phase 3 study of NAFT-600 applied once a day for 2 weeks compared to vehicle (placebo) in the treatment of tinea pedis.
Read the detailed description
This study is open to males and non-pregnant females, 12 years of age and over, with clinical signs and symptoms of tinea pedis consisting of at least moderate erythema, moderate scaling, mild pruritus, a positive screening KOH, and a positive culture.Subjects will be evaluated at Day 1 (baseline), Week 2, Week 4, and Week 6 (follow-up). Adverse events, concomitant medications,and study drug compliance will be reviewed at each visit. Efficacy assessments will include KOH and culture evaluations, clinical signs/symptoms (erythema, scaling, pruritus), and Investigator's Global Assessment.
- Conditions
- Tinea Pedis
- Being tested
- NAFT-600 (naftin 2 % gel), Placebo
- Keywords
- fungal infection, athlete foot
- Medical subject headings
- Tinea Pedis, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAFT-600 (naftin 2 % gel)Drug
Also called Naftin®
Topical; applied once daily for two weeks
PlaceboDrug
Topical; applied once daily for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| NAFT-600 ( naftin 2 % gel) | Experimental | Topical; applied once daily for two weeks Receives: Drug: NAFT-600 (naftin 2 % gel) |
| Placebo | Placebo comparator | Topical; applied once daily for two weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Cure of Interdigital Tinea Pedis
The primary efficacy comparison between NAFT-600 gel and placebo will be based on the percentage of subjects at Week 6 with complete cure of interdigital tinea pedis.
Complete cure is defined as negative mycology results (dermatophyte culture and KOH) and the absence of erythema, scaling, and pruritus.
Measured: Visit 4/ Week 6
Secondary outcomes (1)
Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6
Effective treatment of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture and erythema, scaling, and pruritus scores of 0 or 1 (corresponding to absent and mild respectively).
Mycological cure of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture.
Measured: Visit 4/ Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionNov 2011
- Study completionDec 2011
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 Tinea PedisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 860 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lawrency Parrish, MD, Principal investigator, Paddington Testing Co., Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290341
- Sponsor's protocol ID
- MRZ 90200/3016/1
- Acronym
- NAFT-600
- Status last verified
- Jul 2013
- First submitted
- 28 Jan 2011
- Last updated
- 26 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Double-Blind, Randomized, Placebo-Controlled,Multicenter, Parallel Group Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis
- ClinicalTrials.gov ID
- NCT01290341
- Acronym / sponsor ID
- NAFT-600 / MRZ 90200/3016/1
- Conditions
- Tinea Pedis
- Keywords
- fungal infection, athlete foot
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 860 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Feb 2011 (estimated)
- Results
- Posted 26 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 6-week, double-blind, randomized, placebo-controlled, multicenter, parallel group Phase 3 study of NAFT-600 applied once a day for 2 weeks compared to vehicle (placebo) in the treatment of tinea pedis.
Detailed description
This study is open to males and non-pregnant females, 12 years of age and over, with clinical signs and symptoms of tinea pedis consisting of at least moderate erythema, moderate scaling, mild pruritus, a positive screening KOH, and a positive culture.Subjects will be evaluated at Day 1 (baseline), Week 2, Week 4, and Week 6 (follow-up). Adverse events, concomitant medications,and study drug compliance will be reviewed at each visit. Efficacy assessments will include KOH and culture evaluations, clinical signs/symptoms (erythema, scaling, pruritus), and Investigator's Global Assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAFT-600 ( naftin 2 % gel) | Experimental | Drug: NAFT-600 (naftin 2 % gel)Topical; applied once daily for two weeks |
| Placebo | Placebo comparator | Drug: PlaceboTopical; applied once daily for two weeks. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Males or non-pregnant females, ≥12 years of age, of any race or sex. Females of child-bearing potential must have a negative urine pregnancy test.
- For minors (less than 18 years), the parent/legal guardian must complete the informed consent process AND the subject must complete the assent process and sign the appropriate form (if age appropriate).
- Presence of interdigital only or both interdigital and moccasin types of tinea pedis on one or both feet characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling and mild pruritus) based on signs and symptoms in the affected area(s).
Key exclusion criteria (11 listed)
- Subjects with life-threatening condition (ex. autoimmune deficiency syndrome, cancer, unstable angina or myocardial infarction) within the last 6 months.
- Subjects with abnormal findings - physical or laboratory - that are considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results.
- Subjects with a known hypersensitivity to study drugs or their components.
- Subjects who have a recent history or who are currently known to abuse alcohol or drugs.
- Uncontrolled diabetes mellitus.
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 |
|---|---|---|
| NAFT-600 (naftin 2 % gel)Also: Naftin®Topical; applied once daily for two weeks | Drug | NAFT-600 ( naftin 2 % gel) |
| PlaceboTopical; applied once daily for two weeks. | Drug | Placebo |
Primary outcome
Complete Cure of Interdigital Tinea Pedis
Time frame: Visit 4/ Week 6
The primary efficacy comparison between NAFT-600 gel and placebo will be based on the percentage of subjects at Week 6 with complete cure of interdigital tinea pedis. Complete cure is defined as negative mycology results (dermatophyte culture and KOH) and the absence of erythema, scaling, and pruritus.
1 secondary outcome
Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6
Time frame: Visit 4/ Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2013.
- 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.
Lawrency Parrish, MD principal investigator
Paddington Testing Co., Inc.
23 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 NAFT-600 (naftin 2 % gel) in people with Tinea Pedis, run by Merz North America, Inc. at 23 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 3 inclusion and 11 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 26 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 26 Sep 2013). 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 of Interdigital Tinea Pedis (time frame: Visit 4/ Week 6). 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 26 Sep 2013.