Clinical study on the treatment of scabies disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

INFECTOPHARM Arzneimittel und Consilium GmbH

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Parasitic Diseases [C03]

Trial duration

1 Oct 2024 → ongoing

Decision date (initial)

2024-10-24

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-513288-14-00

EudraCT number

2019-003234-16

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

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).

Secondary objectives 19

1. stage II: Effectiveness (therapy success) for VA1 and VB4
2. stage II: Frequency of a required second treatment, overall and depending on the number of antiscabial pre-treatments
3. stage II: Itching (Numerical Rating Scale (NRS) from 0-10) and change in itching vs. baseline (scale differences) for all visits
4. 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
5. stage 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
6. stage II: Proportion of patients with use of non-trial-conforming antiscabiosa for all visits
7. stage II: Proportion of patients with new scabies efflorescences for all visits
8. 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
9. stages I + II: AEs, SAEs, ADRs, SAEs (total frequency, type, severity, causality, with frequencies, with separate presentation of local reactions)
10. stage I: Effectiveness (treatment 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)
11. stage I: Cumulative efficacy (therapy success) of pure permethrin treatment (i.e. without combined escalation permethrin + ivermectin) by visit type (regular visit, FU visit)
12. 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.
13. stage I: Effectiveness (therapy success) for VS1 and VS2, as well as for the corresponding follow-up visits FUS1 and FUS2 (separately and cumulatively)
14. stage I: Frequency of required repeated standard therapy and escalated therapy
15. 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
16. 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
17. stage I: Proportion of patients with use of antiscabiosa not conforming to the study protocol for all visits, for standard therapy and escalated therapy
18. stage I: Proportion of patients with new scabies efflorescences for all treatment cycles and follow-up visits
19. 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

Conditions and MedDRA coding

Scabies

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. 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
2. Age between 6 and 85 years (stage I) resp. between 2 and 85 years (stage II)
3. 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)
4. 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 22

1. stages I + II: Pre-treatment with antiscabiosa in the last 14 days
2. stages I + II: Obvious unreliability or unwillingness to cooperate
3. stages I + II: Inability to understand and comply with study instructions
4. 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
5. stages I + II: Known alcohol, medication or drug dependency
6. 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)
7. stages I + II: Dependence on sponsor or investigator
8. stages I + II: Combination antiscabial treatment (i.e. simultaneous/simultaneous topical and systemic and systemic scabies treatment with medication) in the last 3 months
9. stages I + II: Previous participation in a clinical trial in the last 30 days or in the same clinical trial
10. 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)
11. stages I + II: Known intolerance to permethrin, other pyrethroids, chrysanthemums or any of the other components of the study medication; stage I: ivermectin
12. stages I + II: Body weight > 120 kg
13. stages I + II: Scabies crustosa
14. stages I + II: Impetiginization/eczematization requiring inpatient treatment
15. stages I + II: Pregnancy, breastfeeding
16. stages I + II: Planned systemic use of corticosteroids
17. 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
18. stages I + II: Planned or previous (last 4 weeks) use of systemic or cutaneous or cutaneous non-steroidal immunosuppressants
19. 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
20. 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)
21. 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
22. stage I: Placement in an institution ordered by a court/authority

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 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.
2. 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 endpoints 19

1. stage II: Effectiveness (therapy success) for VA1 and VB4
2. stage II: Frequency of a required second treatment, overall and depending on the number of antiscabial pre-treatments
3. stage II: Itching (Numerical Rating Scale (NRS) from 0-10) and change in itching vs. baseline (scale differences) for all visits
4. 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
5. 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
6. stages I + II: Proportion of patients with use of non-trial-conforming antiscabiosa for all visits
7. stage II: Proportion of patients with new scabies efflorescences for all visits
8. 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
9. stages I + II: AEs, SAEs, ADRs, SAEs (total frequency, type, severity, causality, with frequencies, with separate presentation of local reactions)
10. 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)
11. stage I: Cumulative efficacy (treatment success) of pure permethrin treatment (i.e. without combined escalation permethrin + ivermectin) by visit type (regular visit, FU visit)
12. 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.
13. stage I: Effectiveness (therapy success) for VS1 and VS2, as well as for the corresponding follow-up visits FUS1 and FUS2 (separately and cumulatively)
14. stage I: Frequency of required repeated standard therapy and escalated therapy
15. 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
16. stage I: Proportion of patients with use of antiscabiosa not conforming to the study protocol for all visits, for standard therapy and escalated therapy
17. stage I: Proportion of patients with new scabies efflorescences for all treatment cycles and follow-up visits
18. 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
19. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

INFECTOPHARM Arzneimittel und Consilium GmbH

Sponsor organisation

INFECTOPHARM Arzneimittel und Consilium GmbH

Address

Von-Humboldt-Strasse 1

City

Heppenheim (Bergstrasse)

Postcode

64646

Country

Germany

Scientific contact point

Organisation

INFECTOPHARM Arzneimittel und Consilium GmbH

Contact name

Dr. Andreas Linke

Public contact point

Organisation

INFECTOPHARM Arzneimittel und Consilium GmbH

Contact name

Dr. Andreas Linke

Third parties 1

Locations

1 EU/EEA country · 8 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 1 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications