Status:
COMPLETED
A Dose Response Trial to Evaluate Clinical and Mycological Effect of Nitric Oxide in Subjects With Tinea Pedis
Lead Sponsor:
Nitric BioTherapeutics, Inc
Conditions:
Tinea Pedis
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
A multi-arm trial to evaluate the efficacy and safety of using gaseous nitric oxide to treat moderate to severe tinea pedis.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00893880
Start Date
June 1 2009
End Date
May 1 2010
Last Update
October 22 2012
Active Locations (4)
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1
Mediprobe Research, Inc
London, Ontario, Canada, N5X 2P1
2
Eureka Health Services
Ramsbury Site, Nevis, Saint Kitts and Nevis
3
Diversified Healthcare Solutions
Basseterre, Saint Kitts, Saint Kitts and Nevis
4
Medical Associates
Basseterre, Saint Kitts, Saint Kitts and Nevis