Ignite Creation Date:
2024-05-06 @ 1:53 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04152226
Status:
COMPLETED
Last Update Posted:
2019-11-05
First Post:
2019-10-28
Brief Title:
Open Label Single-dose Dose Escalating Evaluation of the Safety and Tolerability of DBI-001 in Patients With T Pedis
Sponsor:
DermBiont Inc
Organization:
DermBiont Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None