Prospective, open-label, multicenter, initially 1-arm and, in the event of treatment failure, 3-arm randomised phase III/IV clinical trial on escalating treatment of scabies with INFECTOSCAB 5% (permethrin) (stage I) - with consecutive investigation of the efficacy and safety of two escalated treatment regimens for the treatment of scabies with a higher-concentration permethrin cream (stage II).
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 263
- Locations
- 8
- Primary Endpoint
- 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.
Overview
Brief Summary
stage I: Clinical 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).
stage II: Clinical 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, evaluated 14 days after the (last) application, i.e. treatment success on day 14 (for patients in treatment arm A with only one treatment with permethrin 10% cream) or on day 28 (for patients in treatment arm A with repeated treatment with permethrin 10% cream) and treatment success on day 21 (for patients in treatment arm B).
Eligibility Criteria
- Ages
- 0 years to 65+ years (65+ Years, 0-17 Years, 18-64 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •Age between 6 and 85 years (stage I) resp. between 2 and 85 years (stage II)
- •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)
- •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
- •stages I + II: Pre-treatment with antiscabiosa in the last 14 days
- •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)
- •stages I + II: Known intolerance to permethrin, other pyrethroids, chrysanthemums or any of the other components of the study medication; stage I: ivermectin
- •stages I + II: Body weight > 120 kg
- •stages I + II: Scabies crustosa
- •stages I + II: Impetiginization/eczematization requiring inpatient treatment
- •stages I + II: Pregnancy, breastfeeding
- •stages I + II: Planned systemic use of corticosteroids
- •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
- •stages I + II: Planned or previous (last 4 weeks) use of systemic or cutaneous or cutaneous non-steroidal immunosuppressants
Outcomes
Primary Outcomes
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.
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.
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)
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)
Secondary Outcomes
- stage II: Frequency of a required second treatment, overall and depending on the number of antiscabial pre-treatments
- stage II: Itching (Numerical Rating Scale (NRS) from 0-10) and change in itching vs. baseline (scale differences) for all visits
- 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
- 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
- stages I + II: Proportion of patients with use of non-trial-conforming antiscabiosa for all visits
- stage II: Proportion of patients with new scabies efflorescences for all visits
- 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
- stages I + II: AEs, SAEs, ADRs, SAEs (total frequency, type, severity, causality, with frequencies, with separate presentation of local reactions)
- 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)
- stage I: Cumulative efficacy (treatment success) of pure permethrin treatment (i.e. without combined escalation permethrin + ivermectin) by visit type (regular visit, FU visit)
- 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.
- stage I: Effectiveness (therapy success) for VS1 and VS2, as well as for the corresponding follow-up visits FUS1 and FUS2 (separately and cumulatively)
- stage I: Frequency of required repeated standard therapy and escalated therapy
- 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
- stage I: Proportion of patients with use of antiscabiosa not conforming to the study protocol for all visits, for standard therapy and escalated therapy
- stage I: Proportion of patients with new scabies efflorescences for all treatment cycles and follow-up visits
- 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
- 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
- stage II: Effectiveness (therapy success) for VA1 and VB4
Investigators
Dr. Andreas Linke
Scientific
INFECTOPHARM Arzneimittel und Consilium GmbH