Scabies therapy with two differently concentrated permethrin creams
- Conditions
- ScabiesTherapeutic area: Diseases [C] - Parasitic Diseases [C03]
- Registration Number
- CTIS2023-507925-41-00
- Lead Sponsor
- INFECTOPHARM Arzneimittel und Consilium GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 218
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 2. age between 18 and 85 years 3. written informed consent of the study participant or of all legal guardians and the study participant 4. feasible application of the trial medication by trained specialist personnel at the trial site
1. Pre-treatment with antiscabiosa in the last 14 days 2. Combined antiscabious treatment (i.e. simultaneous topical and systemic drug treatment of scabies) in the last 3 months 3. Known intolerance to permethrin, other pyrethroids, chrysanthemums or any of the other ingredients of the study medication 4. Scabies crustosa 5. Impetiginization/eczematization requiring inpatient treatment 6. Body weight > 120 kg 7. Pregnancy, breastfeeding 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) 9. Other serious illnesses which, in the opinion of the investigator, prevent the patient from participating in the study 10. Planned systemic use of corticosteroids 11. Planned or previous (last 4 weeks) use of systemic or cutaneous non-steroidal immunosuppressants 12. Obvious unreliability or unwillingness to cooperate 13. Inability to understand and comply with study instructions 14. Known alcohol, medication or drug addiction 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 16. 5 or more close contacts (persons with close, extensive skin-to-skin contact with the scabies patient for more than 5-10 minutes) 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) 18. Dependence on sponsor or investigator 19. Previous participation in a clinical trial in the last 30 days or in the same clinical trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to demonstrate the superiority of the clinical efficacy of the new Permethrin Cream 10% for scabies compared to the standard therapy with Permethrin Cream 5% (primary objective).;Secondary Objective: The safety of Permethrin Creme 10%;Primary end point(s): 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).
- Secondary Outcome Measures
Name Time Method