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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-507925-41-00 | Other Identifier | EU-Trial-Nr. (EMA) |
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| Name | Class |
|---|---|
| Winicker Norimed GmbH | INDUSTRY |
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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 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 patient's medical history.
The primary objective of the SKABUP study is the clincal efficacy (therapeutic success yes/no) after completion of treatment (one or - if necessary - two applications), i.e. 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, i.e. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5% Permethrin Creme | Active Comparator | Permethrin Cream 5 % is the already approved standard therapeutic agent InfectoScab 5 % Cream, contains the active ingredient permethrin in a 5 % concentration and is used for the topical treatment of scabies. The cream is also used as a topical cream, e.g. after washing hands. |
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| 10% Permethrin Creme | Experimental | Permethrin Cream 10 % also contains the active ingredient permethrin, but in double the concentration, and otherwise corresponds to the approved standard therapeutic agent InfectoScab 5 % Cream in terms of the main other ingredients. This is also used for the topical treatment of scabies, as well as for re-creaming, e.g. after washing hands. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5% Permethrin Creme | Drug | At visit V0, the investigational cream is applied once topically to the whole body. For patients who are not cured at visit V1, i.e. 14 days later, the application is repeated analogously once at this time. |
| Measure | Description | Time Frame |
|---|---|---|
| clinical efficacy (yes/no) | The primary outcome criterion is defined as clinical efficacy (therapeutic success yes/no) after completion of treatment (one or - if necessary - two applications) i.e. treatment success on day 14 (for study participants with only one investigational product application) or on day 28 (for study participants with repeated investigational product application). | day 14 - day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| effectiveness at Visit 1 | therapy success at Visit 1 | day 14 |
| frequency of therapy success | frequency of therapy success after only one application in relation to the overall frequency of therapy success (after completion of treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bertil Wachall, Dr. | Contact | 06252 95 7000 | clinical.trials@infectopharm.com |
| Name | Affiliation | Role |
|---|---|---|
| Cord Sunderkötter, Prof. Dr. | Universitätsklinik und Poliklinik für Dermatologie une Venerologie, Halle (Saale) | Study Director |
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| ID | Term |
|---|---|
| D012532 | Scabies |
| ID | Term |
|---|---|
| D008924 | Mite Infestations |
| D004478 | Ectoparasitic Infestations |
| D012876 | Skin Diseases, Parasitic |
| D010272 | Parasitic Diseases |
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The SKABUP study is a prospective, randomized, double-blind, 2-arm superiority study in a group sequential design with recruitment stop and interim analysis after 172 patients. If there is no evidence of superiority in the interim analysis, the study will be continued unchanged up to the planned number of 220 patients and will be terminated and analyzed regularly.
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double-blind
| 10% Permethrin Creme | Drug | At visit V0, the investigational cream is applied once topically to the whole body. For patients who are not cured at visit V1, i.e. 14 days later, the application is repeated analogously once at this time. |
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| day 0 - day 28 |
| itching | itching (Numerical Rating Scale (NRS) from 0-10) and change in itching vs. baseline (scale differences) for all visits | day 0 - day 28 |
| patients with evidence of mites | proportion of patients (in %) with evidence of mites (incl. nymphs and larvae, reflected light microscopy or light microscopy of skin samples) for all visits | day 0 - day 28 |
| patients with use of antiscabiosa not compliant with the protocol | proportion of patients with use of antiscabiosa not compliant with the study protocol for all visits | day 0 - day 28 |
| patients with new scabies efflorescences | Proportion of patients with new scabies efflorescences for all visits | day 0 - day 28 |
| patients with "additional confirmed" treatment failure | patients with "additional confirmed" treatment failure (in %): Proportion of patients with new scabies efflorescences at the end of treatment OR with mite detection by microscopic examination of a skin sample OR use of other antiscabio-sa not conforming to the study protocol | day 0 - day 28 |
| AEs, SAEs, ADRs, SUAWs | AEs, SAEs, ADRs, SUAWs (total frequency, type, severity, causality, with frequencies, with separate presentation of local reactions) | day 0 - day 28 |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |