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

NCT ID: NCT00893880

Last Updated: 2012-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-05-31

Brief Summary

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

Conditions

Tinea Pedis

Keywords

Tinea Pedis; Athletes Foot; Nitric Oxide

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

(1) 30min treatment

Group Type: EXPERIMENTAL

1% gaseous Nitric Oxide blended in Oxygen

Intervention Type: DRUG

1% gaseous nitric oxide blended in oxygen applied for 30-60 minutes over 1-2 consecutive days.

2

(1) 60min treatment

Group Type: EXPERIMENTAL

1% gaseous Nitric Oxide blended in Oxygen

Intervention Type: DRUG

1% gaseous nitric oxide blended in oxygen applied for 30-60 minutes over 1-2 consecutive days.

3

(2) 30min treatments over two consecutive days.

Group Type: EXPERIMENTAL

1% gaseous Nitric Oxide blended in Oxygen

Intervention Type: DRUG

1% gaseous nitric oxide blended in oxygen applied for 30-60 minutes over 1-2 consecutive days.

4

(2) 60min treatments over two consecutive days.

Group Type: EXPERIMENTAL

1% gaseous Nitric Oxide blended in Oxygen

Intervention Type: DRUG

1% gaseous nitric oxide blended in oxygen applied for 30-60 minutes over 1-2 consecutive days.

Interventions

1% gaseous Nitric Oxide blended in Oxygen

1% gaseous nitric oxide blended in oxygen applied for 30-60 minutes over 1-2 consecutive days.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nitric BioTherapeutics, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mediprobe Research, Inc

London, Ontario, Canada

Eureka Health Services

Ramsbury Site, Nevis, Saint Kitts and Nevis

Diversified Healthcare Solutions

Basseterre, Saint Kitts, Saint Kitts and Nevis

Medical Associates

Basseterre, Saint Kitts, Saint Kitts and Nevis

Countries

Canada; Saint Kitts and Nevis

Other Identifiers

CTP8

Identifier Type: -

Identifier Source: org_study_id