A Dose Response Trial to Evaluate Clinical and Mycological Effect of Nitric Oxide in Subjects With Tinea Pedis

Tinea Pedis Clinical Trial

Official title:

A Dose Response Trial to Evaluate Clinical and Mycological Effect of Nitric Oxide in Subjects With Tinea Pedis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00893880
• Other study ID #: CTP8
• Status: Completed
• Phase: Phase 2
• First received: May 4, 2009
• Last updated: October 18, 2012
• Start date: June 2009
• Est. completion date: May 2010

Study information

• Verified date: October 2012
• Source: Nitric BioTherapeutics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: St. Kitts and Nevis: Ministry of HealthCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

A multi-arm trial to evaluate the efficacy and safety of using gaseous nitric oxide to treat moderate to severe tinea pedis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: May 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Positive clinical findings (moderate to severe, indicated by a CSSS = 6) for interdigital or bullous tinea pedis as determined by clinical examination (subjects with moccasin symptoms in addition to above may also be included at the discretion of the investigator).

• Written informed consent must be obtained from the subject.

• Must = 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 not be pregnant or nursing, and if of childbearing potential, agree to take measures to avoid pregnancy during the 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 would 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®, Medicis), tolnaftate, haloprogin), Zeasorb-AF , antibacterials and corticosteroids in the preceding 14 days of screening visit (Day 1), on or immediately around the area under evaluation.

• Use of oral or injectable systemic corticosteroids in the preceding 7 or 30 days respectively, of screening visit (Day 1)

• Use of systemic antifungals in the preceding 30 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)

• 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 < 18 years of age, unless local laws dictate otherwise.

• Is immunosuppressed (undergoing chemotherapy, neutropenia (PMNs , < 500/mm3), HIV with CD4+ < 200/mm3.

• 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 STATISTICS This clinical evaluation is intended to demonstrate

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinea
• Tinea Pedis

Intervention

Drug:
• 1% gaseous Nitric Oxide blended in Oxygen
1% gaseous nitric oxide blended in oxygen applied for 30-60 minutes over 1-2 consecutive days.

Locations

Country	Name	City	State
Canada	Mediprobe Research, Inc	London	Ontario
Saint Kitts and Nevis	Diversified Healthcare Solutions	Basseterre	St. Kitts
Saint Kitts and Nevis	Medical Associates	Basseterre	St. Kitts
Saint Kitts and Nevis	Eureka Health Services	Ramsbury Site	Nevis

Sponsors (1)

Lead Sponsor	Collaborator
Nitric BioTherapeutics, Inc

Countries where clinical trial is conducted

Canada,  Saint Kitts and Nevis, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete cure (negative KOH and culture and no signs or symptoms), Effective treatment (negative KOH and culture and at most mild erythema or scaling), Negative mycology (negative KOH and culture).		29 days	Yes
Secondary	Determine the clinical and mycological effect of 1% gaseous nitric oxide (gNO) as a treatment for Tinea Pedis in the clinically evaluable population at the Test-of-Cure (TOC) evaluation (4 weeks post-treatment) according to the definitions below:		29 days	Yes
Secondary	Determine the clinical and mycological effect of the topical application of 1% gNO as confirmed by pre treatment positive culture and clinical signs and symptoms compared to 2 weeks post treatment outcomes according to definitions below:		14 days	Yes
Secondary	Determine the clinical and mycological effect of the topical application of 1% gNO as confirmed by pre treatment positive culture and clinical signs and symptoms compared to 1 week post treatment outcomes according to definitions below:		7 days	Yes
Secondary	Determine the safety of daily topical applications of 1% gNO as confirmed by methemoglobin levels and adverse events.		29 days	Yes