PERMETHRIN for Scabies

Inclusion criteria

• {"criterion_text":"- 1. confirmed acute scabies disease: detection of mites and/or mite nymphs and/or mite larvae, by reflected light microscopy or by light microscopy of skin samples, at predilection sites typical of scabies\n- 2. age between 18 and 85 years\n- 3. written informed consent of the study participant or of all legal guardians and the study participant\n- 4. feasible application of the trial medication by trained specialist personnel at the trial site"}

Exclusion criteria

• {"criterion_text":"- 1. Pre-treatment with antiscabiosa in the last 14 days\n- 2. Combined antiscabious treatment (i.e. simultaneous topical and systemic drug treatment of scabies) in the last 3 months\n- 3. Known intolerance to permethrin, other pyrethroids, chrysanthemums or any of the other ingredients of the study medication\n- 4. Scabies crustosa\n- 5. Impetiginization/eczematization requiring inpatient treatment\n- 6. Body weight > 120 kg\n- 7. Pregnancy, breastfeeding\n- 8. 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)\n- 9. Other serious illnesses which, in the opinion of the investigator, prevent the patient from participating in the study\n- 10. Planned systemic use of corticosteroids\n- 11. Planned or previous (last 4 weeks) use of systemic or cutaneous non-steroidal immunosuppressants\n- 12. Obvious unreliability or unwillingness to cooperate\n- 13. Inability to understand and comply with study instructions\n- 14. Known alcohol, medication or drug addiction\n- 15. Placement in a facility where people live together for a longer period of time, are cared for or receive medical care, and where close skin-to-skin contact is common (e.g. retirement and nursing homes, facilities for people with disabilities, shelters for the homeless, initial reception facilities/emergency accommodation, hospitals) or placement in an institution ordered by a court/authority\n- 16. 5 or more close contacts (persons with close, extensive skin-to-skin contact with the scabies patient for more than 5-10 minutes)\n- 17. Close contact person who refuses scabies treatment or for whom treatment is not possible (According to the RKI, contact persons of a scabies patient are all persons who have had close, extensive skin-to-skin contact with the patient over a longer period of time (longer than 5-10 minutes), e.g. by sleeping together in the same bed, cuddling, body care and caressing of small children, sexual intercourse, body care of sick persons)\n- 18. Dependence on sponsor or investigator\n- 19. Previous participation in a clinical trial in the last 30 days or in the same clinical trial"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint of this study was defined as the clinical efficacy (yes/no) after completion of treatment (depending on the success of treatment with V1 after 14 or after the second treatment after a total of 28 days).","definition_or_measurement_approach":"Clinical efficacy assessed as a binary outcome (yes/no) after completion of treatment, assessed either after V1 at 14 days or after a second treatment at a total of 28 days."}

Germany

Earliest CTIS Part Ii Submission Date

10-06-2024

Latest Decision Or Authorization Date

14-01-2026

Processing Time Days

583

Number Of Sites

13

Number Of Participants

218

Primary sponsor

Full Name

INFECTOPHARM Arzneimittel und Consilium GmbH

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany