Nitric Oxide Releasing Solution (NORS) Footbath to Treat Athlete's Foot

Tinea Pedis Clinical Trial

Official title:

A Blinded Placebo Controlled Clinical Trial To Evaluate Fungicidal Activity With The Topical Application Of Nitric Oxide Releasing Solution (Nors) In Subjects With Moderate To Severe Tinea Pedis (Athlete's Foot)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02871011
• Other study ID #: SAN-CPT-01
• Status: Completed
• Phase: Phase 2
• Start date: August 13, 2016
• Est. completion date: February 21, 2017

Study information

• Verified date: August 2019
• Source: Nitric Solutions Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Sequential Assignment Masking: Double Blind (Subject & Assessor) Primary Purpose: Treatment

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 21, 2017
• Est. primary completion date: November 14, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tinea
• Tinea Pedis

Intervention

Drug:
• Nitric Oxide
Delivered as a footbath
• Water
Delivered as a footbath

Locations

Country	Name	City	State
Canada	Fairmont Medical Clinic	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Nitric Solutions Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Day 17
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.	Day 31
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.	Day 17
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.	Day 31
Primary	Incidence of Adverse Events	Number of moderate A/E possibly related to treatment	Duration of the study, 31 days for each participant.
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.	Day 1 and 31