Tinea Pedis Clinical Trial
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.
Verified date | February 2020 |
Source | Natumin Pharma AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | November 4, 2019 |
Est. primary completion date | November 4, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Signed Informed Consent Form 2. > 18 years of age 3. Tinea pedis (Athlete's foot) confirmed with positive mycological culture for a dermatophyte 4. 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 5. 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 Exclusion Criteria: 1. Patients with negative mycological culture 2. Severe tinea pedis interdigitalis (Athlete's foot) total score of grading sign and symptoms > 16 3. Women pregnant or lactation at time of enrolment 4. Patients using medicinal topical antifungal therapy within 4 weeks prior to study start 5. Treatment with oral terbinafine, itraconazole or fluconazole within 6 months prior to start of study 6. Treatment with other systemic antifungals within 12 weeks prior to start of study 7. Treatment with systemic corticosteroids or immunosuppressants within 6 weeks prior to start of study 8. Any other condition that as judged by the investigator may make follow-up or investigations inappropriate 9. Any patient that according to the Declaration of Helsinki is unsuitable for enrollment |
Country | Name | City | State |
---|---|---|---|
Sweden | Carlanderska sjukhuset | Göteborg | |
Sweden | Univeristetssjukhuset | Örebro | |
Sweden | PTC | Skövde |
Lead Sponsor | Collaborator |
---|---|
Natumin Pharma AB |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline to end of study (8 weeks) | |
Secondary | Frequency of negative fungal culture | Frequency of patients with negative fungal culture at end of study. | Baseline to end of study (8 weeks) | |
Secondary | Frequency of negative KOH test | Frequency of patients with negative KOH test at end of study | Baseline to end of study (8 weeks) | |
Secondary | Tolerability to the device used | Tolerability assessed using a 5-point Likert scale (very good, good, moderate, poor, and very poor) | Baseline to end of study (8 weeks) | |
Secondary | Other clinical signs and symptoms | • Long term follow-up (8 weeks) on patient outcomes on heel cracks(rhagades), calluses and/or dry feet (hyperkeratosis) | Baseline to end of study (8 weeks) | |
Secondary | Dermatology Quality of life | Dermatology QoL Index | Baseline to end of study (8 weeks) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05493488 -
A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Tinea Pedis
|
Phase 2 | |
Completed |
NCT04883593 -
A Study Comparing the Efficacy of TA103 and the Placebo Control in the Treatment of Interdigital Tinea Pedis.
|
Early Phase 1 | |
Terminated |
NCT02842021 -
Efficacy and Safety of Product S2G6T-1in Patients With Symptomatic Inflammatory Interdigital Tinea Pedis
|
Phase 2 | |
Completed |
NCT01712360 -
Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis
|
Phase 4 | |
Completed |
NCT00781664 -
Cumulative Irritation Test
|
Phase 1 | |
Completed |
NCT01519752 -
A Therapeutic Equivalence Study of Two Oxiconazole Nitrate Topical Cream Treatments for Patients With Tinea Pedis
|
Phase 1 | |
Completed |
NCT03320486 -
Non-inferiority Trial of Dapaconazole Versus Ketoconazole
|
Phase 3 | |
Completed |
NCT01580891 -
Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis
|
Phase 1 | |
Completed |
NCT01353976 -
Safety and Efficacy of Econazole Nitrate Foam 1% in Subjects With Tinea Pedis
|
Phase 3 | |
Completed |
NCT01349998 -
Safety of a Topical Antifungal Treatment for Tinea Cruris, Tinea Pedis and Tinea Corporis
|
Phase 3 | |
Completed |
NCT04265521 -
Study With BioCool Footcare in Subjects With Tinea Pedis Interdigitalis and Heel Cracks, Calluses and/or Dry Feet
|
N/A | |
Completed |
NCT02633813 -
BE Study of Naftifine HCL
|
Phase 3 | |
Recruiting |
NCT00856596 -
Once a Day Topical Treatment for Athlete's Foot Fungus Inbetween the Toes in Males and Females
|
Phase 3 | |
Completed |
NCT00869336 -
Multicenter Study of the Efficacy and Safety of Luliconazole Cream in Tinea Pedis (Athlete's Foot)
|
Phase 2 | |
Completed |
NCT00768599 -
A Study of Econazole Foam 1% in Athlete's Foot
|
Phase 2 | |
Recruiting |
NCT00233493 -
Spread of Dermatophytes Among Families
|
N/A | |
Completed |
NCT03897257 -
A Comparison Study of UHE-103 Cream in Subjects With Moccasin Type Tinea Pedis
|
Phase 2 | |
Completed |
NCT03129321 -
Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis
|
Phase 3 | |
Completed |
NCT02335255 -
Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis
|
Phase 1 | |
Withdrawn |
NCT02606383 -
Non-inferiority Phase III Trial Comparing Dapaconazole Cream 2% With Ketoconazole Cream 2% in Patients With Tinea Pedis
|
Phase 3 |