Tinea Pedis Clinical Trial
Official title:
Clinical Study Protocol Number DBI-201. Open Label, Single-dose, Dose Escalating Evaluation of the Safety and Tolerability of DBI-001 in Patients With Tinea Pedis
This is an open- label, single- dose, dose escalating evaluation of the safety and
tolerability of three dose levels of DBI-001 in patients with Tinea pedis.
The purpose of the current protocol is to establish the safety and tolerability of a single
application of J. lividum to the feet of patients with proven T. pedis. In addition, the
effect of J liv on the T. pedis will also be evaluated.
Open- label, single- dose, dose escalating evaluation of the safety and tolerability of three
dose levels of DBI-001 in patients with Tinea pedis.
Study Objectives and Purpose The purpose of the study is to evaluate the safety and
tolerability of DBI-001 in patients with Tinea pedis. Secondly to evaluate presence or
persistence of J. lividum of DBI-001 following a single application of DBI-001. Thirdly to
see the effect on the abundance of T. rubrum. Lastly to see the effect of a single
application of DBI-001 on the signs and symptoms of interdigital T. pedis.
Tolerability will be evaluated through assessment of selected local signs and symptoms (pain
/ burning / stinging, pruritus, erythema, edema, and scabbing / crusting). Any local skin
reaction that requires use of a concomitant therapy or study discontinuation will be reported
;
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|---|---|---|---|
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