Therapy for Scabies With Two Differently Concentrated Permethrin Creams

NCT ID: NCT06380452

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2028-12-31

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%.

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.

Conditions

Scabies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

5% Permethrin Creme

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

10% Permethrin Creme

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Winicker Norimed GmbH

INDUSTRY

Sponsor Role: collaborator

Infectopharm Arzneimittel GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cord Sunderkötter, Prof. Dr.

Role: STUDY_DIRECTOR

Universitätsklinik und Poliklinik für Dermatologie une Venerologie, Halle (Saale)

Central Contacts

Bertil Wachall, Dr.

Role: CONTACT

clinical.trials@infectopharm.com

06252 95 7000

Other Identifiers

2023-507925-41-00

Identifier Type: OTHER

Identifier Source: secondary_id

SKABUP

Identifier Type: -

Identifier Source: org_study_id