Therapy for Scabies With Two Differently Concentrated Permethrin Creams

Last updated: April 22, 2024
Sponsor: Infectopharm Arzneimittel GmbH
Overall Status: Active - Not Recruiting

Phase

3

Condition

Sexually Transmitted Diseases (Stds)

Rash

Treatment

10% Permethrin Creme

5% Permethrin Creme

Clinical Study ID

NCT06380452
SKABUP
2023-507925-41-00
  • Ages 2-85
  • All Genders

Study 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%.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Pre-treatment with antiscabiosa in the last 14 days
  • Combined antiscabial treatment (i.e. simultaneous/simultaneous topical and systemicscabies treatment with medication) in the last 3 months
  • Known intolerance to permethrin, other pyrethroids, chrysanthemums or any of the otheringredients 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 mgprednisolone equivalent >7 days in the last 4 weeks - even without signs of scabiescrustosa)
  • Other serious illnesses which, in the opinion of the investigator, prevent the patientfrom participating in the study
  • Planned systemic use of corticosteroids
  • Planned or previous (last 4 weeks) use of systemic or cutaneous non-steroidalimmunosuppressants
  • 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 caredfor or receive medical care, and where close skin-to-skin contact is common, orplacement in an institution ordered by a court/authority
  • 5 or more close contacts (persons with close, extensive skin-to-skin contact with thescabies patient for more than 5-10 minutes)
  • Close contact person who refuses scabies treatment or for whom treatment is notpossible
  • Dependence on sponsor or investigator
  • Previous participation in a clinical trial in the last 30 days or in the same clinicaltrial

Study Design

Total Participants: 220
Treatment Group(s): 2
Primary Treatment: 10% Permethrin Creme
Phase: 3
Study Start date:
May 01, 2024
Estimated Completion Date:
December 31, 2028

Study 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.