Tinea Pedis

J. Lividum

Instituto Dermatologico y Cirugia de Piel

Open Label, Single-dose, Dose Escalating Evaluation of the Safety and Tolerability of DBI-001 in Patients With T. Pedis

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

Tolerability will be evaluated through assessment local signs and symptoms. Scoring for Fissuring/Cracking, Erythema, Maceration, Scaling, Pruritus, Burning/Stinging:
0 = none (complete absence)
= mild (slight)
= moderate (definitely present)
= severe (marked, intense)

Proportion of samples at each time point in which J. lividum can be detected.

Changes in signs and symptoms of T. pedis Scoring Measure for Fissuring/Cracking, Erythema, Maceration, Scaling, Pruritus, Burning/Stinging: Scoring Measure:
0 = none (complete absence)
= mild (slight)
= moderate (definitely present)
= severe (marked, intense)

DermBiont, Inc.

A single center open label dose escalating study design will be used in a population of patients with interdigital Tinea pedis. Each subject will have a single application of the test article applied to each foot. The three test articles will be a low dose, medium and a high dose of J. lividum. Each of the three groups will have 4 subjects. After the first cohort has completed their day 7 visits and if no significant tolerability of safety issues is identified the second cohort will be enrolled. After the second cohort has completed the day 7 visits and if no significant tolerability or safety issues are identified the third cohort will be enrolled.
At all evaluations, signs and symptoms of application site reactions will be recorded at baseline, as well as days 2, 3, 7, 14, and 28.

tinea/ödem

Open Label, Single-dose, Dose Escalating Evaluation of the Safety and Tolerability of DBI-001 in Patients With T. Pedis

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