Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06380452
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-04-16
Brief Title:
Therapy for Scabies With Two Differently Concentrated Permethrin Creams
Sponsor:
Infectopharm Arzneimittel GmbH
Organization:
Infectopharm Arzneimittel GmbH
Study Overview
Official Title:
Phase III Multicenter Prospective Randomized Double-blind Study Comparing the Efficacy and Safety of Therapy for Scabies With Two Differently Concentrated Permethrin Creams
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
SKABUP
Brief Summary:
The multi-center prospective randomized double-blind phase III clinical trial will primarily investigate the efficacy and safety of treatment of scabies with Permethrin Cream 5 approved drug InfectoScab 5 Cream in direct comparison with Permethrin Cream 10
The trial participants will be randomly assigned and blinded to either Permethrin Cream 5 or Permethrin Cream 10
The trial participants will be randomly assigned and blinded to either Permethrin Cream 5 or Permethrin Cream 10
Detailed Description:
The SKABUP study is a multi-center prospective randomized double-blind phase III clinical trial The aim of this SKABUP study is to compare the efficacy and safety of topical therapy with permethrin 5 and permethrin 10 in a multicenter randomized double-blind setting in order to demonstrate the possible superiority of the 10 permethrin cream over the current standard therapy with permethrin 5 cream In order to demonstrate a possible difference in efficacy as clearly as possible the study will be conducted in dermatology clinics and without extensive exclusion of previous therapies in the patients medical history
The primary objective of the SKABUP study is the clincal efficacy therapeutic success yesno after completion of treatment one or - if necessary - two applications ie treatment success on day 14 for study participants with only one application of investigational product or on day 28 for study participants with repeated application of investigational product
A total of 220 scabies patients aged between 2 and 85 years are to be included in the study clinical trial After 172 patients however recruitment will be stopped and an interim evaluation carried out If there is proof of superiority the study will be terminated if there is no proof of superiority it will be continued unchanged Study drop-outs ie patients included in the study with at least one application of an investigational product whose participation in the study ends prematurely will not be replaced
The primary objective of the SKABUP study is the clincal efficacy therapeutic success yesno after completion of treatment one or - if necessary - two applications ie treatment success on day 14 for study participants with only one application of investigational product or on day 28 for study participants with repeated application of investigational product
A total of 220 scabies patients aged between 2 and 85 years are to be included in the study clinical trial After 172 patients however recruitment will be stopped and an interim evaluation carried out If there is proof of superiority the study will be terminated if there is no proof of superiority it will be continued unchanged Study drop-outs ie patients included in the study with at least one application of an investigational product whose participation in the study ends prematurely will not be replaced
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-507925-41-00 | OTHER | EU-Trial-Nr EMA | None |