Therapy for Scabies With Two Differently Concentrated Permethrin Creams (SKABUP)

Phase III Multicenter, Prospective, Randomized, Double-blind Study Comparing the Efficacy and Safety of Therapy for Scabies With Two Differently Concentrated Permethrin Creams.

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%.

Study Overview

• Status: Not yet recruiting
• Conditions: Scabies
• Intervention / Treatment: Drug: 5% Permethrin Creme; Drug: 10% Permethrin Creme

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Bertil Wachall, Dr.; Phone Number: 06252 95 7000; Email: clinical.trials@infectopharm.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Confirmed acute scabies disease: Detection of mites and/or mite nymphs and/or mite larvae, by reflected light microscopy or light microscopy of skin samples, at scabies-typical predilection sites
• Age between 2 years and 85 years
• Written informed consent of the study participant (if of legal age) or all legal guardians (for underage study participants < 12 years) or all legal guardians and the study participant (for underage study participants ≥ 12 years)
• Practicable application of the trial medication by trained specialist staff at the trial site

Exclusion Criteria:

• Pre-treatment with antiscabiosa in the last 14 days
• Combined antiscabial treatment (i.e. simultaneous/simultaneous topical and systemic scabies treatment with medication) in the last 3 months
• Known intolerance to permethrin, other pyrethroids, chrysanthemums or any of the other ingredients of the study medication
• Scabies crustosa
• Impetiginization/eczematization requiring inpatient treatment
• Body weight > 120 kg
• Pregnancy, breastfeeding
• Clinically relevant immunodeficiency (of any kind, including extensive local therapy (>20% body surface) with corticosteroids > 2 weeks in the last 4 weeks or ≥ 10 mg prednisolone equivalent >7 days in the last 4 weeks - even without signs of scabies crustosa)
• Other serious illnesses which, in the opinion of the investigator, prevent the patient from participating in the study
• Planned systemic use of corticosteroids
• Planned or previous (last 4 weeks) use of systemic or cutaneous non-steroidal immunosuppressants
• Apparent unreliability or unwillingness to cooperate
• Inability to understand and comply with study instructions
• Known alcohol, medication or drug dependence
• Placement in a facility where people live together for long periods of time, are cared for or receive medical care, and where close skin-to-skin contact is common, or placement in an institution ordered by a court/authority
• 5 or more close contacts (persons with close, extensive skin-to-skin contact with the scabies patient for more than 5-10 minutes)
• Close contact person who refuses scabies treatment or for whom treatment is not possible
• Dependence on sponsor or investigator
• Previous participation in a clinical trial in the last 30 days or in the same clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 5% Permethrin Creme; 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.	Drug: 5% Permethrin Creme; 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.
Experimental: 10% Permethrin Creme; 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.	Drug: 10% Permethrin Creme; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Infectopharm Arzneimittel GmbH
• Collaborators: Winicker Norimed GmbH
• Investigators: Study Director: Cord Sunderkötter, Prof. Dr., Universitätsklinik und Poliklinik für Dermatologie une Venerologie, Halle (Saale)

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Parasitic Diseases; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Mite Infestations; Scabies; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Permethrin
• Other Study ID Numbers: SKABUP; 2023-507925-41-00 (Other Identifier: EU-Trial-Nr. (EMA))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No