Tinea PedisPhase 3NCT01433107

Efficacy and Safety of Terbinafine Film Forming Solution in Patients With Tinea Pedis

A Phase 3 study testing Terbinafine in people with Tinea Pedis, run by Novartis at 6 sites in China.

Completed

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

Trial summary

This study will compare the efficacy and safety of a single dose of terbinafine film forming solution 1% with a single dose of placebo film forming solution in the treatment of tinea pedis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Tinea Pedis
What is being tested?: Terbinafine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 290 participants
Where: 6 sitesChina
Study dates: Aug 2011to Feb 2012
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

Patients ≥18 years of age with interdigital tinea pedis infection, with clinical diagnosis meeting required baseline total sign \& symptom score and positive microscopy

Who cannot join

Allergy to the allylamine class of antimycotics or excipients in the formulation.
Chronic, hyperkeratotic plantar (moccasin) tinea pedis
Other fungal disease or intertrigo
Other abnormal findings on the affected foot
Systemic antifungal or antimicrobial treatment within the last 3 months
Topical treatment for skin lesions on feet within the last 3 months
Diabetes mellitus and peripheral artery occlusive disease

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

China6 sites

Peking University First Hospital
Beijing, 100034
Beijing University Hospital N°3
Beijing, 100083
The Second Affiliated Hospital of Sun Yat-sen University Guangzhou
Guangdong, 510120
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, 510630
Chinese Academy of Medical Sciences
Jiangsu, 21004
Huashan Hospital, Fudan University
Shanghai, 200040

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study of the Efficacy and Safety of Terbinafine Film Forming Solution, 1% (as Hydrochloride), in Patients With Tinea Pedis

This study will compare the efficacy and safety of a single dose of terbinafine film forming solution 1% with a single dose of placebo film forming solution in the treatment of tinea pedis.

Conditions: Tinea Pedis
Being tested: Terbinafine, Terbinafine Placebo
Keywords: Tinea pedis, Terbinafine film forming solution
Medical subject headings: Tinea Pedis

What participants receive

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

TerbinafineDrug
1% single application
Terbinafine PlaceboDrug
single application

Study groups in NCT01433107
Study group	Role	What they receive
Terbinafine	Experimental	Drug Receives: Drug: Terbinafine
Placebo	Placebo comparator	Drug Receives: Drug: Terbinafine Placebo

What is being measured

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

Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2)
Each clinical sign or symptom will be assessed separately. The investigator will evaluate the severity of each sign or symptom over the entire target foot. Clinical signs and symptoms including desquamation (scaling), erythema, incrustation (crusting), pustules, vesiculation and pruritus will be evaluated by the investigator or designee and recorded at every visit using the following scale:
0 = absent
1. = mild
2. = moderate
3. = severe In order to calculate the total symptoms score the rating for all symptoms are added up.
Possible range 0 to 18
Measured: week 6

Secondary outcomes (2)

Total Clinical Signs and Symptoms (S/S) Scores
Each clinical sign or symptom will be assessed separately. The investigator will evaluate the severity of each sign or symptom over the entire target foot. Clinical signs and symptoms including desquamation (scaling), erythema, incrustation (crusting), pustules, vesiculation and pruritus will be evaluated by the investigator or designee and recorded at every visit using the following scale:
0 = absent
1. = mild
2. = moderate
3. = severe In order to calculate the total symptom score, the scores for each individual symptom are added up.
Possible range : 0 to 18
Measured: week 6
Number of Subjects With Adverse Event
Number of Subjects with adverse event
Measured: 6 weeks

Timeline

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

Aug 2011Feb 2012

First posted13 Sep 2011 (estimated)
Study startAug 2011
Primary completionFeb 2012
Study completionFeb 2012

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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 290 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01433107
Sponsor's protocol ID: 727-D-301
Status last verified: Dec 2013
First submitted: 8 Sep 2011
Last updated: 27 Dec 2013
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

RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
RecruitingPhase 1
A Phase 1b Study of ZYG24004 in Participants With Tinea Pedis Caused by Dermatophytes
Tinea Pedis
Recruiting
Atmospheric Pressure Cold Plasma for Moderate-to-severe Tinea Pedis
Tinea Pedis
RecruitingPhase 2
Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study
Tinea Pedis
Not yet recruitingObservational study
Sports Nutrition Assessment Program
Diet Habit, Body Weight

All Tinea Pedis trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study of the Efficacy and Safety of Terbinafine Film Forming Solution, 1% (as Hydrochloride), in Patients With Tinea Pedis
ClinicalTrials.gov ID: NCT01433107
Acronym / sponsor ID: 727-D-301
Conditions: Tinea Pedis
Keywords: Tinea pedis, Terbinafine film forming solution
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 290 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Aug 2011
Primary completion: Feb 2012 (actual)
Study completion: Feb 2012 (actual)
First posted: 13 Sep 2011 (estimated)
Results: Posted 27 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will compare the efficacy and safety of a single dose of terbinafine film forming solution 1% with a single dose of placebo film forming solution in the treatment of tinea pedis.

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
Terbinafine	Experimental	Drug: TerbinafineDrug
Placebo	Placebo comparator	Drug: Terbinafine PlaceboDrug

Who may qualify

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

Key inclusion criteria (1 listed)

Patients ≥18 years of age with interdigital tinea pedis infection, with clinical diagnosis meeting required baseline total sign \& symptom score and positive microscopy

Key exclusion criteria (7 listed)

Allergy to the allylamine class of antimycotics or excipients in the formulation.
Chronic, hyperkeratotic plantar (moccasin) tinea pedis
Other fungal disease or intertrigo
Other abnormal findings on the affected foot
Systemic antifungal or antimicrobial treatment within the last 3 months

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
Terbinafine1% single application	Drug	Terbinafine
Terbinafine Placebosingle application	Drug	Placebo

Primary outcome

Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2)
Time frame: week 6
Each clinical sign or symptom will be assessed separately. The investigator will evaluate the severity of each sign or symptom over the entire target foot. Clinical signs and symptoms including desquamation (scaling), erythema, incrustation (crusting), pustules, vesiculation and pruritus will be evaluated by the investigator or designee and recorded at every visit using the following scale: 0 = absent 1. = mild 2. = moderate 3. = severe In order to calculate the total symptoms score the rating for all symptoms are added up. Possible range 0 to 18

2 secondary outcomes

Total Clinical Signs and Symptoms (S/S) Scores
Time frame: week 6
Number of Subjects With Adverse Event
Time frame: 6 weeks

Results and safety

Results posted to the registry on 27 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Terbinafine	145	118
Placebo	145	128

Primary outcome: Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2)

Time frame: week 6. Number. Unit: participants

Measure	Terbinafine n = 115	Placebo n = 122
Value	73	10

Population analysed: Number of success. The discrepancy between number of participants analyzed and participants completed is explained by delayed exclusions (people having negative mycology results received after completion of the study).

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Terbinafine	0 of 146 (0%)	0 of 146 (0%)	Not reported
Placebo	0 of 144 (0%)	7 of 144 (4.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Tinea Pedis

RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
RecruitingPhase 1
A Phase 1b Study of ZYG24004 in Participants With Tinea Pedis Caused by Dermatophytes
Tinea Pedis
Recruiting
Atmospheric Pressure Cold Plasma for Moderate-to-severe Tinea Pedis
Tinea Pedis
RecruitingPhase 2
Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study
Tinea Pedis
Not yet recruitingObservational study
Sports Nutrition Assessment Program
Diet Habit, Body Weight

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.

The record lists no contact. Use the official record to reach the sponsor.

6 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 Terbinafine in people with Tinea Pedis, run by Novartis at 6 sites in China.

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 1 inclusion and 7 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 27 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. 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 27 Dec 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?

Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2) (time frame: week 6). 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 NCT01433107.

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 27 Dec 2013.