An interventional study of Nåva Foot Cream in Tinea Pedis, sponsored by Natumin Pharma AB. Completed at 3 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-25.
Sponsored by Natumin Pharma AB · Not applicable, Interventional, and Treatment
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.
73 studies on the registry are indexed under Tinea Pedis; 8 are open to participants now.
This study's enrollment of 46 is below the median of 128 across 66 interventional studies indexed under Tinea Pedis.
Browse Tinea Pedis studies →This is the only study on the registry with Natumin Pharma AB as lead sponsor.
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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
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Topical Nåva foot cream administered twice daily.
Device: Nåva Foot Cream
Nåva Foot Cream is a Medical device (EU class IIa) for the treatment of tinea pedis, heal cracks, calluses and dry feet.
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.
Time frame: Baseline to end of study (8 weeks)
Frequency of negative fungal culture
Frequency of patients with negative fungal culture at end of study.
Time frame: Baseline to end of study (8 weeks)
Frequency of negative KOH test
Frequency of patients with negative KOH test at end of study
Time frame: 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)
Time frame: 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)
Time frame: Baseline to end of study (8 weeks)
Dermatology Quality of life
Dermatology QoL Index
Time frame: Baseline to end of study (8 weeks)
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2018 to primary completion in Nov 2019, 13 months.
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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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