Tinea PedisNCT03676686
Study With Nåva Foot Cream in Patients With Tinea Pedis Interdigitalis
A study testing Nåva Foot Cream in people with Tinea Pedis, run by Natumin Pharma AB at 3 sites in Sweden.
Trial summary
A prospective, open post-market clinical investigation that will enroll male and female subjects diagnosed with foot fungus and at least one of the following conditions: heal cracks, calluses and/or dry feet. 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?
- Nåva Foot Cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 3 sitesSweden
- Study dates
- 1 Oct 2018to 4 Nov 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form
- > 18 years of age
- Tinea pedis (Athlete's foot) confirmed with positive mycological culture for a dermatophyte
- Total score of 6-16 when grading the eight sign and symptoms of tinea pedis (erythema, erosions, macerations, pruritus, fissures, burning/stinging, hyperkeratosis, odour) using a 4-point severity scale (0=absent, 1= mild, 2= moderate, 3=severe)
- o Score of 2 or higher required in at least one of the following: erythema, pruritus, macerations or odour
- Score of at least 2 (moderate) required in at least one of the following: heel cracks (rhagades), calluses and dry feet (hyperkeratosis) using a 5-point severity scale (0=absent, 1= mild, 2= moderate, 3= advanced, 4=severe) age
Who cannot join
- Patients with negative mycological culture
- Severe tinea pedis interdigitalis (Athlete's foot) total score of grading sign and symptoms > 16
- Women pregnant or lactation at time of enrolment
- Patients using medicinal topical antifungal therapy within 4 weeks prior to study start
- Treatment with oral terbinafine, itraconazole or fluconazole within 6 months prior to start of study
- Treatment with other systemic antifungals within 12 weeks prior to start of study
Show all 9Show fewer
- Treatment with systemic corticosteroids or immunosuppressants within 6 weeks prior to start of study
- Any other condition that as judged by the investigator may make follow-up or investigations inappropriate
- Any patient that according to the Declaration of Helsinki is unsuitable for enrollment
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Carlanderska sjukhuset
Gothenburg
Univeristetssjukhuset
Örebro
PTC
Skövde
About this study
Official title: A Prospective Single-arm Investigation to Assess the Efficacy, of Topical "Nåva" Foot Cream for 8 Weeks of Treatment in Patients With Mild to Moderate Tinea Pedis Interdigitalis and Heal Cracks, Calluses and/or Dry Feet.
A prospective, open post-market clinical investigation that will enroll male and female subjects diagnosed with foot fungus and at least one of the following conditions: heal cracks, calluses and/or dry feet. The investigation population will consist of 48 subjects fulfilling the eligibility criteria for the clinical investigation. The subjects will all be treated with the study product, Nåva Foot Cream. The duration of the investigation is estimated to 6 months, including a 2-month recruitment period and 2-month follow up period.
- Conditions
- Tinea Pedis
- Being tested
- Nåva Foot Cream
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nåva Foot CreamDevice
Nåva Foot Cream is a Medical device (EU class IIa) for the treatment of tinea pedis, heal cracks, calluses and dry feet.
| Study group | Role | What they receive |
|---|---|---|
| Nåva Foot Cream | Experimental | Topical Nåva foot cream administered twice daily. Receives: Device: Nåva Foot Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective clinical treatment rate
Change of total mean score (TMS): Improvement of 8 clinical signs and symptoms of foot fungus calculated as the total score of all using a 4-point severity scale for each symptom.
Measured: Baseline to end of study (8 weeks)
Secondary outcomes (5)
Frequency of negative fungal culture
Frequency of patients with negative fungal culture at end of study.
Measured: Baseline to end of study (8 weeks)
Frequency of negative KOH test
Frequency of patients with negative KOH test at end of study
Measured: Baseline to end of study (8 weeks)
Tolerability to the device used
Tolerability assessed using a 5-point Likert scale (very good, good, moderate, poor, and very poor)
Measured: Baseline to end of study (8 weeks)
Other clinical signs and symptoms
- Long term follow-up (8 weeks) on patient outcomes on heel cracks(rhagades), calluses and/or dry feet (hyperkeratosis)
Measured: Baseline to end of study (8 weeks)
Dermatology Quality of life
Dermatology QoL Index
Measured: Baseline to end of study (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start1 Oct 2018
- Primary completion4 Nov 2019
- Study completion4 Nov 2019
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natumin Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Lundvall, Principal investigator, Region Örebro län
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676686
- Sponsor's protocol ID
- Nåva Foot Cream_1
- Status last verified
- Feb 2020
- First submitted
- 17 Sep 2018
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-arm Investigation to Assess the Efficacy, of Topical "Nåva" Foot Cream for 8 Weeks of Treatment in Patients With Mild to Moderate Tinea Pedis Interdigitalis and Heal Cracks, Calluses and/or Dry Feet.
- ClinicalTrials.gov ID
- NCT03676686
- Acronym / sponsor ID
- Nåva Foot Cream_1
- Conditions
- Tinea Pedis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Natumin Pharma ABIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 19 Sep 2018 (actual)
- 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.
A prospective, open post-market clinical investigation that will enroll male and female subjects diagnosed with foot fungus and at least one of the following conditions: heal cracks, calluses and/or dry feet. The investigation population will consist of 48 subjects fulfilling the eligibility criteria for the clinical investigation. The subjects will all be treated with the study product, Nåva Foot Cream. The duration of the investigation is estimated to 6 months, including a 2-month recruitment period and 2-month follow up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nåva Foot Cream | Experimental | Device: Nåva Foot CreamTopical Nåva foot cream administered twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed Informed Consent Form
- > 18 years of age
- Tinea pedis (Athlete's foot) confirmed with positive mycological culture for a dermatophyte
- Total score of 6-16 when grading the eight sign and symptoms of tinea pedis (erythema, erosions, macerations, pruritus, fissures, burning/stinging, hyperkeratosis, odour) using a 4-point severity scale (0=absent, 1= mild, 2= moderate, 3=severe)
- o Score of 2 or higher required in at least one of the following: erythema, pruritus, macerations or odour
Key exclusion criteria (9 listed)
- Patients with negative mycological culture
- Severe tinea pedis interdigitalis (Athlete's foot) total score of grading sign and symptoms > 16
- Women pregnant or lactation at time of enrolment
- Patients using medicinal topical antifungal therapy within 4 weeks prior to study start
- Treatment with oral terbinafine, itraconazole or fluconazole within 6 months prior to start of 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 |
|---|---|---|
| Nåva Foot CreamNåva Foot Cream is a Medical device (EU class IIa) for the treatment of tinea pedis, heal cracks, calluses and dry feet. | Device | Nåva Foot Cream |
Primary outcome
Effective clinical treatment rate
Time frame: Baseline to end of study (8 weeks)
Change of total mean score (TMS): Improvement of 8 clinical signs and symptoms of foot fungus calculated as the total score of all using a 4-point severity scale for each symptom.
5 secondary outcomes
Frequency of negative fungal culture
Time frame: Baseline to end of study (8 weeks)
Frequency of negative KOH test
Time frame: Baseline to end of study (8 weeks)
Tolerability to the device used
Time frame: Baseline to end of study (8 weeks)
Other clinical signs and symptoms
Time frame: Baseline to end of study (8 weeks)
Dermatology Quality of life
Time frame: Baseline to end of study (8 weeks)
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 25 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Martin Lundvall principal investigator
Region Örebro län
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nåva Foot Cream in people with Tinea Pedis, run by Natumin Pharma AB at 3 sites in Sweden.
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 6 inclusion and 9 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 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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.
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?
Effective clinical treatment rate (time frame: Baseline to end of study (8 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 25 Feb 2020.