Tinea Pedis
Conditions
Keywords
Tinea Bronchodilator Agents, Tinea Pedis, Nitric Oxide, Dermatomycoses, Endothelium-Dependent Relaxing Factors, Infectious, Infection, Mycoses, Skin Diseases, Foot Dermatoses, Foot Diseases, Pruritus, Skin Manifestations Signs and Symptoms
Brief summary
The purpose of this study is to determine the fungicidal efficacy of nitric oxide releasing solution footbath and it's effect on the clinical signs and symptoms associated with Tinea Pedis
Detailed description
Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Sequential Assignment Masking: Double Blind (Subject & Assessor) Primary Purpose: Treatment
Interventions
DRUGNitric Oxide
Delivered as a footbath
DRUGWater
Delivered as a footbath
Sponsors
Nitric Solutions Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Positive clinical findings for moccasin, interdigital or bullous tinea pedis as determined by direct clinical examination * Must have a clinical symptom severity score of at least 20 on a possible 64 point scale * Written informed consent must be obtained from the subject. * Must ≥ 19 years of age, for study sites located in British Columbia. For other locations the subject must be ≥ 18 years of age, unless local laws dictate otherwise. * Must agree to avoid professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit until the conclusion of the trial. * Must agree to take measures to avoid pregnancy during the 31 day study period
Exclusion criteria
* Has a diagnosis of either psoriasis or eczema, in or immediately around the area under evaluation. * Has a visual diagnosis, by the investigator, of onychomycosis at a level, which in the opinion of the investigator could compromise the integrity of the study. * Use of topical antifungals e.g. (clotrimazole, ketoconazole,miconazole, oxiconazole- (Oxistat®, Glaxo Smith Kline), sulconazole, naftifine (Naftin®, Merz), terconazole, econazole nitrate (Spectazole®, Ortho-McNeil), butoconazole ,Fluconazole, ciclopirox olamine-(Loprox®), tolnaftate, haloprogin), Zeasorb, antibacterials and corticosteroids in the preceding 5 days of screening visit (Day 1) on or immediately around the area under evaluation. * Use of systemic corticosteroids in the preceding 7 days respectively, of screening visit (Day 1) * Use of systemic antifungals in the preceding 7 days of screening visit (Day1) including - (terbinafine - (Lamisil®, Novartis), Itraconazole - (Sporanox®, Janssen), fluconazole- (Diflucan®, Pfizer), ketoconazole, miconazole, griseofulvin (GrisPEG®), butoconazole, terconazole, Potassium iodide) * Has used any investigational drug(s) within 30 days preceding screening visit (Day 1) * Is pregnant or is a nursing mother * Is a woman of child bearing potential who is not using an adequate form of contraception (or abstinence) * Is \< 19 years of age, for study sites located in British Columbia. For other locations subject is \< 18 years of age, unless local laws dictate otherwise. * Suffers from a condition, which, in the opinion of the medical investigator, would compromise his/her safety and / or the quality of the data. Such conditions may include collagen vascular disease, diabetes mellitus, Cushing's Disease, hematological malignancy, chronic mucocutaneous candidiasis or atopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complete Cure: Post Treatment (Day 17) | Day 17 | Complete cure will be determined by negative fungal culture or negative microscopic evaluation via KOH preparation and a Clinical Symptom Severity Score of ≤ 8 (0-64) on Day 17. Improvement is expressed as a lower score. |
| Number of Participants With Complete Cure: Post Treatment (Day 31) | Day 31 | Complete cure will be determined by a minimum of a 12- point reduction on day 17 in the Clinical Symptom Severity Score (from \>20 to \<8) on a scale of 0-64. Improvement is expressed as a lower score. |
| Number of Participants With Therapeutic Failure: Post Treatment (Day 17) | Day 17 | Positive fungi colonization via mycological culture OR microscopic evaluation (KOH) AND a post treatment Clinical Symptom Severity Score of ≤ 8 (0-64) on Day 17. Improvement is expressed as a lower score. |
| Number of Participants withTherapeutic Failure: Post Treatment Day 31 AND a Post Treatment Clinical Symptom Severity Score (Day 31) of < 8. | Day 31 | Positive fungi colonization via mycological culture OR microscopic evaluation (KOH) AND a post treatment Clinical Symptom Severity Score of ≤ 8 (0-64) on Day 31. Improvement is expressed as a lower score. |
| Incidence of Adverse Events | Duration of the study, 31 days for each participant. | Number of moderate A/E possibly related to treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Participants Clinical Symptom Severity Score Between Day 1 and Day 31 | Day 1 and 31 | Clinical Symptom Severity Score change in score on Day and Day 31 between all participants with an initial Clinical Symptom severity Score of \>20 (0-64 scale) in the two study groups. Increased improvement is expressed as largest negative change and a lower score. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days.
Water: Delivered as a footbath | 7 |
| Nitric Oxide Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days.
Nitric Oxide: Delivered as a footbath | 13 |
| Total | 20 |
Baseline characteristics
| Characteristic | Control | Nitric Oxide | Total |
|---|---|---|---|
| Age, Continuous | 53.1 years | 53.2 years | 53.2 years |
| Region of Enrollment Canada | 7 participants | 13 participants | 20 participants |
| Sex: Female, Male Female | 0 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 7 Participants | 10 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 13 |
| other Total, other adverse events | 0 / 7 | 3 / 13 |
| serious Total, serious adverse events | 0 / 7 | 0 / 13 |
Outcome results
Primary
Incidence of Adverse Events
Number of moderate A/E possibly related to treatment
Time frame: Duration of the study, 31 days for each participant.
Population: Intent to treat enrollment was 20 individuals.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Incidence of Adverse Events | 0 Events |
| Nitric Oxide | Incidence of Adverse Events | 3 Events |
Primary
Number of Participants With Complete Cure: Post Treatment (Day 17)
Complete cure will be determined by negative fungal culture or negative microscopic evaluation via KOH preparation and a Clinical Symptom Severity Score of ≤ 8 (0-64) on Day 17. Improvement is expressed as a lower score.
Time frame: Day 17
Population: Intent to treat enrollment was 20 individuals but per protocol only a total of 12 participants met the criteria for both a positive fungal culture and microscopic evaluation at baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants With Complete Cure: Post Treatment (Day 17) | 0 Participants |
| Nitric Oxide | Number of Participants With Complete Cure: Post Treatment (Day 17) | 4 Participants |
Primary
Number of Participants With Complete Cure: Post Treatment (Day 31)
Complete cure will be determined by a minimum of a 12- point reduction on day 17 in the Clinical Symptom Severity Score (from \>20 to \<8) on a scale of 0-64. Improvement is expressed as a lower score.
Time frame: Day 31
Population: Intent to treat enrollment was 20 individuals but per protocol only a total of 12 participants met the criteria for both a positive fungal culture and microscopic evaluation at baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants With Complete Cure: Post Treatment (Day 31) | 0 Participants |
| Nitric Oxide | Number of Participants With Complete Cure: Post Treatment (Day 31) | 5 Participants |
Primary
Number of Participants With Therapeutic Failure: Post Treatment (Day 17)
Positive fungi colonization via mycological culture OR microscopic evaluation (KOH) AND a post treatment Clinical Symptom Severity Score of ≤ 8 (0-64) on Day 17. Improvement is expressed as a lower score.
Time frame: Day 17
Population: Intent to treat enrollment was 20 individuals but per protocol only a total of 12 participants met the criteria for both a positive fungal culture and microscopic evaluation at baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants With Therapeutic Failure: Post Treatment (Day 17) | 2 Participants |
| Nitric Oxide | Number of Participants With Therapeutic Failure: Post Treatment (Day 17) | 0 Participants |
Primary
Number of Participants withTherapeutic Failure: Post Treatment Day 31 AND a Post Treatment Clinical Symptom Severity Score (Day 31) of < 8.
Positive fungi colonization via mycological culture OR microscopic evaluation (KOH) AND a post treatment Clinical Symptom Severity Score of ≤ 8 (0-64) on Day 31. Improvement is expressed as a lower score.
Time frame: Day 31
Population: Intent to treat enrollment was 20 individuals but per protocol only a total of 12 participants met the criteria for both a positive fungal culture and microscopic evaluation at baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants withTherapeutic Failure: Post Treatment Day 31 AND a Post Treatment Clinical Symptom Severity Score (Day 31) of < 8. | 1 Participants |
| Nitric Oxide | Number of Participants withTherapeutic Failure: Post Treatment Day 31 AND a Post Treatment Clinical Symptom Severity Score (Day 31) of < 8. | 0 Participants |
Secondary
Change in Participants Clinical Symptom Severity Score Between Day 1 and Day 31
Clinical Symptom Severity Score change in score on Day and Day 31 between all participants with an initial Clinical Symptom severity Score of \>20 (0-64 scale) in the two study groups. Increased improvement is expressed as largest negative change and a lower score.
Time frame: Day 1 and 31
Population: Intent to treat enrollment was 20 individuals.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in Participants Clinical Symptom Severity Score Between Day 1 and Day 31 | -3.4 Clinial symptom Severity Score | Standard Deviation 8.6 |
| Nitric Oxide | Change in Participants Clinical Symptom Severity Score Between Day 1 and Day 31 | -18.8 Clinial symptom Severity Score | Standard Deviation 7.1 |