Scabies therapy with two differently concentrated permethrin creams

Overview

Sponsor-declared trial summary

Key facts

Sponsor

INFECTOPHARM Arzneimittel und Consilium GmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Parasitic Diseases [C03]

Trial duration

14 Aug 2024 → ongoing

Decision date (initial)

2024-07-05

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

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 objectives 1

1. The safety of Permethrin Creme 10%

Conditions and MedDRA coding

Scabies

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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

Exclusion criteria 1

1. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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).

Investigational products

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

Test 1

Comparator 1

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

InfectoPharm

Public contact point

Organisation

INFECTOPHARM Arzneimittel und Consilium GmbH

Contact name

InfectoPharm

Locations

1 EU/EEA country · 13 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

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

Documents 11 files

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

Application history

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