Therapy for Scabies With Two Differently Concentrated Permethrin Creams

Launched by INFECTOPHARM ARZNEIMITTEL GMBH · Apr 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of two different strengths of Permethrin Cream in treating scabies, a skin condition caused by tiny mites. Participants will be randomly assigned to receive either Permethrin Cream 5% or Permethrin Cream 10%, and neither the participants nor the researchers will know which cream they are receiving. The trial aims to determine which strength works better for patients with scabies.

To be eligible for the trial, participants need to have a confirmed case of scabies, be between the ages of 2 and 85, and have the ability to give informed consent (or have their guardians do so if they are underage). However, people who have used scabies treatments recently, are pregnant or breastfeeding, or have certain health conditions may not qualify. If you choose to participate, you will receive the treatment at a specialized site where trained staff will guide you through the process. This trial is not yet recruiting participants, but it aims to gather important data to improve scabies treatment.

Gender

ALL

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