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

NCT02871011 | Completed Phase 2 Results

• 1 other identifier: SAN-CPT-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Tinea Pedis

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

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• Incidence of Adverse Events

  Number of moderate A/E possibly related to treatment

  Duration of the study, 31 days for each participant.

Secondary Outcomes (1)

• Change in Participants Clinical Symptom Severity Score Between Day 1 and Day 31

  Day 1 and 31

Study Arms (2)

Control

PLACEBO COMPARATOR

Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days.

Drug: Water

Nitric oxide

EXPERIMENTAL

Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days.

Drug: Nitric Oxide

Interventions

Nitric Oxide DRUG

Delivered as a footbath

Also known as: NORS

Nitric oxide

Water DRUG

Delivered as a footbath

Also known as: Placebo

Control

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nitric Solutions Inc.: lead

Study Sites (1)

Fairmont Medical Clinic

Vancouver, British Columbia, V5Z-16H, Canada

Location

MeSH Terms

Conditions

Tinea Pedis; Dermatomycoses; Communicable Diseases; Infections; Mycoses; Skin Diseases; Foot Dermatoses; Foot Diseases; Pruritus

Interventions

Nitric Oxide; Water

Condition Hierarchy (Ancestors)

Tinea; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals; Hydroxides; Alkalies; Anions; Ions; Electrolytes

Results Point of Contact

• Title: Dr Chris Miller
• Organization: SaNOtize Research & Development Corp.

chris@sanotize.com

778-899-0607

Study Officials

• Lisa Miller, M.D.

  Nitric Solutions Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 18, 2016
• Study Start: August 13, 2016
• Primary Completion: November 14, 2016
• Study Completion: February 21, 2017
• Last Updated: September 20, 2019
• Results First Posted: September 20, 2019

Record last verified: 2019-08

Locations

CA (1)