Tinea PedisPhase 3NCT00856596
Once a Day Topical Treatment for Athlete's Foot Fungus Inbetween the Toes in Males and Females
A Phase 3 study testing Sertaconazole nitrate cream 2% in people with Tinea Pedis and Athlete's Foot, run by Jamaica Hospital Medical Center at 1 site in United States.
Trial summary
The topical cream, Sertaconazole (Ertaczo), has been FDA approved for the treatment of athlete's foot using twice a day dosing for 4 weeks. This study wants to see if sertaconazole will work equally as well with once a day dosing for 4 weeks for athlete's foot. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tinea Pedis, Athlete's Foot, Foot Fungus
- What is being tested?
- Sertaconazole nitrate cream 2%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Sep 2009
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females 18 years of age and over.
- Women of child bearing age must have a negative urine pregnancy test at Day 0 (baseline) and Day 42 (visit 6) or at the discontinuation visit and must agree to use an acceptable method of contraception during the study.
- Subjects must have clinical evidence of interdigital tinea pedis of one or both feet characterized by: moderate erythema and scaling and mild pruritis.
- The clinical diagnosis must be confirmed by a positive KOH preparation, where fungal elements are visible from a skin scraping of the interdigital area of the feet.
- Fungal cultures obtained at the baseline visit must be positive by day 14 for the subject to remain in the study.
- All non-study medications not specifically excluded by this protocol may be continued.
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- All chronic diseases must be stable for at least one month.
- Acute illnesses must be stabilized before enrollment.
- The subject must be able to understand what is required, read and sign the informed consent, comply with the requirements of this study and adhere to the visit schedule.
Who cannot join
- Under 18 years of age.
- Pregnant or lactating females.
- Treatment of sertaconazole or an investigational drug within the last 30 days prior to study enrollment.
- No medications or emollients or foot powders or treatments other than those used in the study are to be applied to the treatment areas.
- The following medications may not be used during the study:
- Oral anti-fungals 3 months prior to enrollment
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- Topical anti-fungals to the feet 14 days prior to enrollment
- Systemic antibiotic or corticosteroid 30 days prior to enrollment
- Topical corticosteroid 30 days prior to enrollment
- Use of radiation therapy and/or anti-neoplastic agents within1 year of enrollment
- Widespread dermatophytosis: moccasin tinea pedis, onychomycosis, oral, vaginal or chronic mucocutaneous candidiasis, bacterial skin infection.
- Subject who are known or suspected to be immunocompromised.
- Known sensitivity to any components of the test medication or hypersensitivity to imidazoles.
- Any disease or condition that may compromise the evaluation of the therapeutic response of tinea pedis to treatment.
- History of drug or alcohol dependency in the last 6 months.
- History of atopic or contact dermatitis on the feet.
- Unstable diabetes mellitus.
- Subjects who have participated in any previous clinical trial of sertaconazole.
- Subjects who cannot or will not sign the informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Jamaica Hospital Medical Center
Jamaica, New York, 11418
Evelyn Koestenblatt, 212-523-4511, dermtrial@gmail.com
Jeffrey Weinberg, MD
About this study
Official title: Efficacy Of Sertaconazole 2% (ERTACZO) in the Treatment of Interdigital Tinea Pedis With Once a Day Treatment for 4 Weeks
The topical cream, Sertaconazole (Ertaczo), has been FDA approved for the treatment of athlete's foot using twice a day dosing for 4 weeks. This study wants to see if sertaconazole will work equally as well with once a day dosing for 4 weeks for athlete's foot.
Read the detailed description
The dermatophytes are a group of pathogenic fungi that inhabit and invade keratinized tissue including hair, skin and nails in humans. Infections caused by the three genera of organisms making up the dermatophytes include: Trichophyton, Microsporum and Epidermophyton. Infections due to the dermatophytes are termed dermatophytosis or tinea.
Tinea pedis (athlete's foot) is most commonly caused by Trichophyton rubrum, and less commonly by Trichophyton mentagrophytes and Epidermophyton floccosum.
Tinea infections have been on the rise for variety of reasons including: an aging population, an increase in immunocompromised individuals, increase use of gyms, swimming pools, sports activities, wearing of occlusive footwear, and the organisms themselves becoming more resistant to therapy.
Treatment for tinea pedis usually involves the use of topical therapy with azoles or similar antifungal agents. The efficacy of the topical agent depends on the duration of therapy, type of lesion, the mechanism of action of the drug, and the viscosity, hydrophobicity and acidity of the formulation.
Sertaconazole is a broad spectrum, antifungal agent effective against Candida and dermatophytes. It has also shown antibacterial and anti-inflammatory activity. Skin absorption studies have revealed acceptable therapeutic levels of sertaconazole remained in the skin until 48 hours after application. Half life for drug clearance from the skin is 60 hours. Skin tolerability and phototoxicity studies have revealed sertaconazole to be effective and safe when compared to other topical antifungal agents.
In 2004 sertaconazole nitrate 2% cream, was FDA approved for the topical treatment of interdigital tinea pedis in immunocompetent patients 12 years of age and older, caused by Trichophyton rubrum. Trichophyton mentagrophytes and Epidermophyton floccosum. The approved dosage is twice a day for a total of four weeks to the affected area. This treatment regimen may prove to be difficult for many patients to follow and cause a lower cure rate than would be expected.
It would seem reasonable to postulate that a once a day application would provide adequate therapeutic levels for interdigital tinea pedis based on several previous findings. Acceptable therapeutic levels of drug were maintained in the skin after 48 hours of application and the half-life of the drug is 60 hours. Patient compliance and therefore a higher mycological cure rate and better clinical outcome should theoretically occur with once a day dosing of sertaconazole 2%. Once a day dosing should prevent early discontinuation and better compliance for patients with tinea pedis.
- Conditions
- Tinea Pedis, Athlete's Foot, Foot Fungus, Ringworm
- Being tested
- Sertaconazole nitrate cream 2%
- Keywords
- Tinea pedis, Fungus, Pruritus, Dermatophyte, Athlete's foot, Dermatomycosis, Skin manifestation, Infectious skin disease, Foot diseases
- Medical subject headings
- Tinea Pedis, Tinea, Pruritus, Dermatomycoses, Skin Manifestations, Skin Diseases, Infectious, Foot Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sertaconazole nitrate cream 2%Drug
Also called Ertaczo cream 2%
Once a day topical cream
| Study group | Role | What they receive |
|---|---|---|
| Males and females with athlete's foot | Other | Male and female subjects with athlete's foot inbetween their toes without nail involvement Receives: Drug: Sertaconazole nitrate cream 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy and safety of sertaconazole 2% cream applied once a day for four weeks in the treatment of patients with KOH positive and culture positive symptomatic interdigital tinea pedis (athlete's foot).
Measured: Baseline visit, 1 week, 2 weeks, 4 weeks, 6 weeks
Secondary outcomes (1)
To compare the time to successful clinical and mycological treatment outcomes for sertaconazole 2% cream applied once a day for four weeks in the treatment of patients with KOH positive and culture positive symptomatic interdigital tinea pedis.
Measured: Baseline visit, 1 week, 2 weeks, 4 weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jamaica Hospital Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Investigators
- Jeffrey Weinberg, MD, Principal investigator, Jamaica Hospital Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00856596
- Sponsor's protocol ID
- 08023
- Status last verified
- Aug 2009
- First submitted
- 5 Mar 2009
- Last updated
- 6 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Sertaconazole 2% (ERTACZO) in the Treatment of Interdigital Tinea Pedis With Once a Day Treatment for 4 Weeks
- ClinicalTrials.gov ID
- NCT00856596
- Acronym / sponsor ID
- 08023
- Conditions
- Tinea Pedis, Athlete's Foot, Foot Fungus, Ringworm
- Keywords
- Tinea pedis, Fungus, Pruritus, Dermatophyte, Athlete's foot, Dermatomycosis, Skin manifestation, Infectious skin disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jamaica Hospital Medical CenterUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- Mar 2009
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 6 Mar 2009 (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 topical cream, Sertaconazole (Ertaczo), has been FDA approved for the treatment of athlete's foot using twice a day dosing for 4 weeks. This study wants to see if sertaconazole will work equally as well with once a day dosing for 4 weeks for athlete's foot.
Detailed description
The dermatophytes are a group of pathogenic fungi that inhabit and invade keratinized tissue including hair, skin and nails in humans. Infections caused by the three genera of organisms making up the dermatophytes include: Trichophyton, Microsporum and Epidermophyton. Infections due to the dermatophytes are termed dermatophytosis or tinea.
Tinea pedis (athlete's foot) is most commonly caused by Trichophyton rubrum, and less commonly by Trichophyton mentagrophytes and Epidermophyton floccosum.
Tinea infections have been on the rise for variety of reasons including: an aging population, an increase in immunocompromised individuals, increase use of gyms, swimming pools, sports activities, wearing of occlusive footwear, and the organisms themselves becoming more resistant to therapy.
Treatment for tinea pedis usually involves the use of topical therapy with azoles or similar antifungal agents. The efficacy of the topical agent depends on the duration of therapy, type of lesion, the mechanism of action of the drug, and the viscosity, hydrophobicity and acidity of the formulation.
Sertaconazole is a broad spectrum, antifungal agent effective against Candida and dermatophytes. It has also shown antibacterial and anti-inflammatory activity. Skin absorption studies have revealed acceptable therapeutic levels of sertaconazole remained in the skin until 48 hours after application. Half life for drug clearance from the skin is 60 hours. Skin tolerability and phototoxicity studies have revealed sertaconazole to be effective and safe when compared to other topical antifungal agents.
In 2004 sertaconazole nitrate 2% cream, was FDA approved for the topical treatment of interdigital tinea pedis in immunocompetent patients 12 years of age and older, caused by Trichophyton rubrum. Trichophyton mentagrophytes and Epidermophyton floccosum. The approved dosage is twice a day for a total of four weeks to the affected area. This treatment regimen may prove to be difficult for many patients to follow and cause a lower cure rate than would be expected.
It would seem reasonable to postulate that a once a day application would provide adequate therapeutic levels for interdigital tinea pedis based on several previous findings. Acceptable therapeutic levels of drug were maintained in the skin after 48 hours of application and the half-life of the drug is 60 hours. Patient compliance and therefore a higher mycological cure rate and better clinical outcome should theoretically occur with once a day dosing of sertaconazole 2%. Once a day dosing should prevent early discontinuation and better compliance for patients with tinea pedis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Males and females with athlete's foot | Other | Drug: Sertaconazole nitrate cream 2%Male and female subjects with athlete's foot inbetween their toes without nail involvement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females 18 years of age and over.
- Women of child bearing age must have a negative urine pregnancy test at Day 0 (baseline) and Day 42 (visit 6) or at the discontinuation visit and must agree to use an acceptable method of contraception during the study.
- Subjects must have clinical evidence of interdigital tinea pedis of one or both feet characterized by: moderate erythema and scaling and mild pruritis.
- The clinical diagnosis must be confirmed by a positive KOH preparation, where fungal elements are visible from a skin scraping of the interdigital area of the feet.
- Fungal cultures obtained at the baseline visit must be positive by day 14 for the subject to remain in the study.
Key exclusion criteria (19 listed)
- Under 18 years of age.
- Pregnant or lactating females.
- Treatment of sertaconazole or an investigational drug within the last 30 days prior to study enrollment.
- No medications or emollients or foot powders or treatments other than those used in the study are to be applied to the treatment areas.
- The following medications may not be used 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 |
|---|---|---|
| Sertaconazole nitrate cream 2%Also: Ertaczo cream 2%Once a day topical cream | Drug | Males and females with athlete's foot |
Primary outcome
To compare the efficacy and safety of sertaconazole 2% cream applied once a day for four weeks in the treatment of patients with KOH positive and culture positive symptomatic interdigital tinea pedis (athlete's foot).
Time frame: Baseline visit, 1 week, 2 weeks, 4 weeks, 6 weeks
1 secondary outcome
To compare the time to successful clinical and mycological treatment outcomes for sertaconazole 2% cream applied once a day for four weeks in the treatment of patients with KOH positive and culture positive symptomatic interdigital tinea pedis.
Time frame: Baseline visit, 1 week, 2 weeks, 4 weeks, 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2009.
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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.
Jeffrey Weinberg, MD principal investigator
Jamaica Hospital Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sertaconazole nitrate cream 2% in people with Tinea Pedis and Athlete's Foot, run by Jamaica Hospital Medical Center 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 19 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: status not confirmed, as of the sponsor's last update on 6 Aug 2009. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evelyn Koestenblatt (212-523-4511, dermtrial@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the efficacy and safety of sertaconazole 2% cream applied once a day for four weeks in the treatment of patients with KOH positive and culture positive symptomatic interdigital tinea pedis (athlete's foot). (time frame: Baseline visit, 1 week, 2 weeks, 4 weeks, 6 weeks). 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 6 Aug 2009.