Permethrin for Scabies

Inclusion criteria

• {"criterion_text":"- stages I +II: 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 predilection sites typical of scabies\n- Age between 6 and 85 years (stage I) resp. between 2 and 85 years (stage II)\n- stages I + II: Written declaration of consent from 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)\n- stages I + II: Application of the investigational medication by trained specialist staff at the trial site (standard case), or, if not feasible in private practice, guaranteed availability of a third person (e.g. close contact person) who supports the patient in the application of the investigational medication in areas that are otherwise not/only partially accessible to the patient."}

Exclusion criteria

• {"criterion_text":"- stages I + II: Pre-treatment with antiscabiosa in the last 14 days\n- stages I + II: More than 2 started therapy attempts for scabies treatment in the last 3 months or more than 3 started therapy attempts in the last 6 months (one therapy attempt consists of a) one topical application of permethrin, b) one systemic application of ivermectin, c) one topical application of benzyl benzoate on up to three consecutive days, d) one topical application of crotamiton on up to five consecutive days). five consecutive days)\n- stages I + II: Known intolerance to permethrin, other pyrethroids, chrysanthemums or any of the other components of the study medication; stage I: ivermectin\n- stages I + II: Body weight > 120 kg\n- stages I + II: Scabies crustosa\n- stages I + II: Impetiginization/eczematization requiring inpatient treatment\n- stages I + II: Pregnancy, breastfeeding\n- stages I + II: Planned systemic use of corticosteroids\n- stages I + II: Immunodeficiency (of any kind, including previous extensive local therapy (>20% body surface area) 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- stages I + II: Planned or previous (last 4 weeks) use of systemic or cutaneous or cutaneous non-steroidal immunosuppressants\n- stages I + II: Other serious illnesses which, in the opinion of the investigator, prevent the patient from participating in the study; stage I: including with regard to risk factors for severe COVID-19 disease progression in the event of SARS-CoV-2 infection\n- stages I + II: Obvious unreliability or unwillingness to cooperate\n- stage II: More than 4 close contact persons (persons with close, extensive skin-to-skin contact with the scabies patient for more than 5-10 minutes)\n- stage II: At least one close contact person who refuses (synchronous) co-treatment (within or outside the study) or for whom such treatment is not feasible\n- stage I: Placement in an institution ordered by a court/authority\n- stages I + II: Inability to understand and comply with study instructions\n- stage II: Placement in facilities 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 (e.g. retirement and nursing homes, facilities for people with disabilities, homeless shelters, initial reception facilities/emergency shelters, hospitals) or court/authority-ordered placement in an institution\n- stages I + II: Known alcohol, medication or drug dependency\n- stage I: Known or clinically suspected disruption of the blood-brain barrier (e.g. ABCB-1 (=MDR-1) mutation), as well as a history of known neurotoxic effects caused by ivermectin or other substrates/inhibitors of the para-glycoprotein (P-gp)\n- stages I + II: Dependence on sponsor or investigator\n- stages I + II: Combination antiscabial treatment (i.e. simultaneous/simultaneous topical and systemic and systemic scabies treatment with medication) in the last 3 months\n- stages I + II: Previous participation in a clinical trial in the last 30 days or in the same clinical trial"}

Primary endpoints

• {"endpoint_text":"- stage II: Efficacy (yes/no) of treatment with permethrin 10% cream after one or - if necessary - two whole-body applications in study arm A or two whole-body applications in study arm B, assessed 14 days after (last) application, i.e. treatment success on day 14 or day 28 for patients in arm A or on day 21 for patients in arm B.","definition_or_measurement_approach":"Binary efficacy (yes/no) assessed as treatment success at specified post-application timepoints: day 14 or day 28 for arm A, day 21 for arm B; assessment by clinical evaluation and/or microscopy as specified in protocol."}
• {"endpoint_text":"- stage I: Efficacy (yes/no) after completion of the first treatment cycle (InfectoScab 5% cream standard therapy, one or - if necessary - two applications), i.e. treatment success on day 14 (for patients with only one InfectoScab 5% cream standard treatment) or on day 28 (for patients with repeated InfectoScab 5% cream standard treatment)","definition_or_measurement_approach":"Binary efficacy (yes/no) assessed as treatment success at day 14 (single application) or day 28 (repeated application) following standard InfectoScab 5% cream therapy; clinical and/or microscopic confirmation per protocol."}

Secondary endpoints

• {"endpoint_text":"- stage II: Effectiveness (therapy success) for VA1 and VB4","definition_or_measurement_approach":"Effectiveness (therapy success) by visit/timepoint VA1 and VB4 as defined in protocol (binary outcome per visit)."}
• {"endpoint_text":"- stage II: Frequency of a required second treatment, overall and depending on the number of antiscabial pre-treatments","definition_or_measurement_approach":"Count/proportion of patients requiring a second treatment, analysed overall and stratified by number of prior antiscabial treatments."}
• {"endpoint_text":"- stage II: Itching (Numerical Rating Scale (NRS) from 0-10) and change in itching vs. baseline (scale differences) for all visits","definition_or_measurement_approach":"Patient-reported itch measured by NRS 0-10 and change from baseline at all visits."}
• {"endpoint_text":"- stages I + II: Number and type of affected body regions (wrists/hands, arm pits, armpits, genito armpits, armpits, genitoanal region, groin, knees, feet/ankles/lower thighs, head thighs, head, trunk, other) for all visits","definition_or_measurement_approach":"Clinical recording of number and anatomical location(s) of affected regions at each visit."}
• {"endpoint_text":"- stages I + II: Proportion of patients (in %) with evidence of mites (incl. nymphs and larvae, reflected light microscopy or light microscopy of skin samples) for all visits","definition_or_measurement_approach":"Proportion with microscopic evidence of mites (nymphs/larvae) by reflected light or light microscopy of skin samples at visits."}
• {"endpoint_text":"- stages I + II: Proportion of patients with use of non-trial-conforming antiscabiosa for all visits","definition_or_measurement_approach":"Proportion of patients reporting or found to have used antiscabial treatments not conforming to study protocol."}
• {"endpoint_text":"- stage II: Proportion of patients with new scabies efflorescences for all visits","definition_or_measurement_approach":"Proportion with newly observed scabies lesions (efflorescences) at visits."}
• {"endpoint_text":"- stage II: Patients with “additionally confirmed” treatment failure (in %): Proportion of patients with new scabies efflorescences at the end of study participation OR with mite detection by microscopic examination of a skin sample at the aforementioned time points OR use of other antiscabiosa not conforming to the study protocol","definition_or_measurement_approach":"Composite endpoint: proportion meeting any of the listed criteria (new efflorescences, positive microscopy, non-protocol antiscabial use) indicating confirmed treatment failure."}
• {"endpoint_text":"- stages I + II: AEs, SAEs, ADRs, SAEs (total frequency, type, severity, causality, with frequencies, with separate presentation of local reactions)","definition_or_measurement_approach":"Safety outcomes: frequency, type, severity and causality of AEs/SAEs/ADRs with separate reporting for local reactions per standard pharmacovigilance definitions."}
• {"endpoint_text":"- stage I: Effectiveness (therapy success) for VE5, VE101/2 (separately and cumulatively) and VEK as well as for the corresponding follow-up visits FUE5/E10/EK, separately and cumulatively by visit type (regular visit, FU visit)","definition_or_measurement_approach":"Therapy success measured per specified visit codes VE5, VE101/2, VEK and follow-up visits, analysed separately and cumulatively by visit type."}
• {"endpoint_text":"- stage I: Cumulative efficacy (treatment success) of pure permethrin treatment (i.e. without combined escalation permethrin + ivermectin) by visit type (regular visit, FU visit)","definition_or_measurement_approach":"Cumulative proportion of patients achieving treatment success with permethrin-only regimens, stratified by visit type."}
• {"endpoint_text":"- stage I: Patients with reinfestation (in %): Proportion of patients with microscopically confirmed new efflorescences at the end of standard therapy or escalated therapy (respective FU) who were assessed as cured at the immediately preceding control-visit.","definition_or_measurement_approach":"Proportion with microscopically confirmed new lesions at end of therapy among those previously assessed as cured at prior visit."}
• {"endpoint_text":"- stage I: Effectiveness (therapy success) for VS1 and VS2, as well as for the corresponding follow-up visits FUS1 and FUS2 (separately and cumulatively)","definition_or_measurement_approach":"Therapy success per visit codes VS1/VS2 and corresponding follow-ups, analysed separately and cumulatively."}
• {"endpoint_text":"- stage I: Frequency of required repeated standard therapy and escalated therapy","definition_or_measurement_approach":"Count/proportion of patients receiving repeated standard or escalated therapy."}
• {"endpoint_text":"- stage I: Itching (Numerical Rating Scale (NRS) from 0-10) and change in itching vs baseline (scale differences) for all visits, for standard therapy and escalated therapy and for escalated therapy additionally the change in itching vs start of escalated therapy","definition_or_measurement_approach":"Patient-reported itch by NRS 0-10 and changes from baseline and from start of escalated therapy as applicable."}
• {"endpoint_text":"- stage I: Proportion of patients (in %) with detection of mites (incl. nymphs and larvae, reflected light microscopy or light microscopy of skin samples) for all visits, for standard therapy and escalated therapy","definition_or_measurement_approach":"Proportion with microscopic mite detection by treatment group (standard vs escalated) at each visit."}
• {"endpoint_text":"- stage I: Proportion of patients with use of antiscabiosa not conforming to the study protocol for all visits, for standard therapy and escalated therapy","definition_or_measurement_approach":"Proportion using non-protocol antiscabial treatments by therapy group at visits."}
• {"endpoint_text":"- stage I: Proportion of patients with new scabies efflorescences for all treatment cycles and follow-up visits","definition_or_measurement_approach":"Proportion with new lesions across treatment cycles and follow-up visits."}
• {"endpoint_text":"- stage I: Patients with “additionally confirmed” treatment failure (in %): Proportion of patients with new scabies efflorescences at the end of standard therapy (VS2) or escalated therapy (VE5, VEK, VE102) OR with mite detection by microscopic examination of a skin sample at the aforementioned time points OR use of other antiscabiosa not conforming to the study protocol during the respective therapy cycle","definition_or_measurement_approach":"Composite failure endpoint as defined (new efflorescences, positive microscopy, non-protocol antiscabial use) by therapy cycle."}

Germany

Earliest CTIS Part Ii Submission Date

16-09-2024

Latest Decision Or Authorization Date

02-09-2025

Processing Time Days

351

Number Of Sites

8

Number Of Participants

263

Primary sponsor

Full Name

INFECTOPHARM Arzneimittel und Consilium GmbH

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Contract research organisations

Name

Winicker-Norimed GmbH Medizinische Forschung

Responsibilities

Sponsor duties codes: 1;10;11;6 (as listed in thirdParty sponsorDuties)

Third parties

• {"country":"Germany","full_name":"Winicker-Norimed GmbH Medizinische Forschung","duties_or_roles":"1;10;11;6","organisation_type":"Pharmaceutical company"}