Efficacy Study to Evaluate the Effect of Nitric Oxide on the Treatment of Tinea Pedis (Athlete's Foot)

NCT00771342 | Completed Phase 2

• 1 other identifier: CTP 6
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the fungicidal efficacy of nitric oxide and it's effect on the clinical signs and symptoms associated with Tinea Pedis

Conditions

Tinea

Outcome Measures

Primary Outcomes (1)

• Evidence of fungicidal activity as confirmed by mycological culture or microscopic evaluation and improvement in Clinical Symptom Severity Score

  Day 12 or Day 26

Secondary Outcomes (1)

• Incidence of adverse events

  Duration of the study

Study Arms (2)

1

EXPERIMENTAL

1% gasoue nitric oxide, delivered topically for 40 minutes daily for three consecutive days

Drug: Nitric Oxide

2

PLACEBO COMPARATOR

Nitrogen gas delivered topically for 40 minutes, daily, for 3 consecutive days

Drug: Nitrogen

Interventions

Nitric Oxide DRUG

1% gaseous nitric oxide, delivered for 40 minutes daily for 3 consecutive days

1

Nitrogen DRUG

Nitrogen gas, delivered topically for 40 minutes daily for 3 consecutive days

2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• 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
• 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 12 day (or 26 day if in cross over group) study period

You may not qualify if:

• Has a diagnosis of either psoriasis or eczema
• Has a visual diagnosis, by the investigator, of onychomycosis.
• 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®, Medicis), tolnaftate, haloprogin), Zeasorb-AF , antibacterials and corticosteroids in the preceding 5 days of screening visit (Day 1)
• Use of systemic corticosteroids in the preceding 7 days 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 (Gris-PEG®, Pedinol), butoconazole, terconazole, Potassium iodide)
• Has used any investigational drug(s) within 30 days preceding screening visit (Day 1)
• Has cardiovascular disease, diabetes mellitus, Cushing's Disease, hematological malignancy, chronic mucocutaneous candidiasis or atopy
• 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
• Suffers from a condition, which, in the opinion of the medical investigator, would compromise his/her safety

Sponsors & Collaborators

• Nitric BioTherapeutics, Inc: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Tinea

Interventions

Nitric Oxide; Nitrogen

Condition Hierarchy (Ancestors)

Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals; Elements; Gases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 10, 2008
• First Posted: October 13, 2008
• Study Start: December 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2009
• Last Updated: February 3, 2010

Record last verified: 2010-02

Locations

CA (1)