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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Nitric BioTherapeutics, Inc

ClinicalTrials.gov Identifier:

NCT00893880

First received: May 4, 2009

Last updated: October 18, 2012

Last verified: October 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	May 4, 2009
Last Updated Date	October 18, 2012
Start Date ^ICMJE	June 2009
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 5, 2009)	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). [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00893880 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 5, 2009)	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: [ Time Frame: 29 days ] [ Designated as safety issue: Yes ] 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: [ Time Frame: 14 days ] [ Designated as safety issue: Yes ] 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: [ Time Frame: 7 days ] [ Designated as safety issue: Yes ] Determine the safety of daily topical applications of 1% gNO as confirmed by methemoglobin levels and adverse events. [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Dose Response Trial to Evaluate Clinical and Mycological Effect of Nitric Oxide in Subjects With Tinea Pedis
Official Title ^ICMJE	A Dose Response Trial to Evaluate Clinical and Mycological Effect of Nitric Oxide in Subjects With Tinea Pedis
Brief Summary	A multi-arm trial to evaluate the efficacy and safety of using gaseous nitric oxide to treat moderate to severe tinea pedis.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Tinea Pedis
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: 1 (1) 30min treatment Intervention: Drug: 1% gaseous Nitric Oxide blended in Oxygen Experimental: 2 (1) 60min treatment Intervention: Drug: 1% gaseous Nitric Oxide blended in Oxygen Experimental: 3 (2) 30min treatments over two consecutive days. Intervention: Drug: 1% gaseous Nitric Oxide blended in Oxygen Experimental: 4 (2) 60min treatments over two consecutive days. Intervention: Drug: 1% gaseous Nitric Oxide blended in Oxygen
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	92
Completion Date	May 2010
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	19 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada, Saint Kitts and Nevis

Administrative Information
NCT Number ^ICMJE	NCT00893880
Other Study ID Numbers ^ICMJE	CTP8
Has Data Monitoring Committee	No
Responsible Party	Nitric BioTherapeutics, Inc
Study Sponsor ^ICMJE	Nitric BioTherapeutics, Inc
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Nitric BioTherapeutics, Inc
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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