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

Nitric BioTherapeutics

Status and phase: Completed; Phase 2

Conditions: Tinea Pedis

Treatments: Drug: 1% gaseous Nitric Oxide blended in Oxygen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00893880

CTP8

Details and patient eligibility

About

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

Enrollment: 92 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

92 participants in 4 patient groups

1

Experimental group

Description:

(1) 30min treatment

Treatment:

Drug: 1% gaseous Nitric Oxide blended in Oxygen

2

Experimental group

Description:

(1) 60min treatment

Treatment:

Drug: 1% gaseous Nitric Oxide blended in Oxygen

3

Experimental group

Description:

(2) 30min treatments over two consecutive days.

Treatment:

Drug: 1% gaseous Nitric Oxide blended in Oxygen

4

Experimental group

Description:

(2) 60min treatments over two consecutive days.

Treatment:

Drug: 1% gaseous Nitric Oxide blended in Oxygen