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Therapy for Scabies With Two Differently Concentrated Permethrin Creams

NCT06380452 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2024-04-23

No results posted yet for this 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%.

Conditions

  • Scabies

Interventions

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.

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.

Sponsors & Collaborators

  • Winicker Norimed GmbH

    collaborator INDUSTRY

  • Infectopharm Arzneimittel GmbH

    lead INDUSTRY

Principal Investigators

  • Cord Sunderkötter, Prof. Dr. · Universitätsklinik und Poliklinik für Dermatologie une Venerologie, Halle (Saale)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2027-07-31
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06380452 on ClinicalTrials.gov