Therapy for Scabies With Two Differently Concentrated Permethrin Creams

NCT06380452 | Not Yet Recruiting Phase 3

• 2 other identifiers: SKABUP2023-507925-41-00
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief Summary

The multi-center, prospective, randomized, double-blind phase III clinical trial will primarily investigate the efficacy and safety of treatment of scabies with Permethrin Cream 5% (approved drug InfectoScab 5% Cream) in direct comparison with Permethrin Cream 10%. The trial participants will be randomly assigned and blinded to either Permethrin Cream 5% or Permethrin Cream 10%.

Conditions

Scabies

Outcome Measures

Primary Outcomes (1)

• clinical efficacy (yes/no)

  The primary outcome criterion is defined as clinical efficacy (therapeutic success yes/no) after completion of treatment (one or - if necessary - two applications) i.e. treatment success on day 14 (for study participants with only one investigational product application) or on day 28 (for study participants with repeated investigational product application).

  day 14 - day 28

Secondary Outcomes (8)

• effectiveness at Visit 1

  day 14

• frequency of therapy success

  day 0 - day 28

• itching

  day 0 - day 28

• patients with evidence of mites

  day 0 - day 28

• patients with use of antiscabiosa not compliant with the protocol

  day 0 - day 28

Study Arms (2)

5% Permethrin Creme

ACTIVE COMPARATOR

Permethrin Cream 5 % is the already approved standard therapeutic agent InfectoScab 5 % Cream, contains the active ingredient permethrin in a 5 % concentration and is used for the topical treatment of scabies. The cream is also used as a topical cream, e.g. after washing hands.

Drug: 5% Permethrin Creme

10% Permethrin Creme

EXPERIMENTAL

Permethrin Cream 10 % also contains the active ingredient permethrin, but in double the concentration, and otherwise corresponds to the approved standard therapeutic agent InfectoScab 5 % Cream in terms of the main other ingredients. This is also used for the topical treatment of scabies, as well as for re-creaming, e.g. after washing hands.

Drug: 10% Permethrin Creme

Interventions

5% Permethrin Creme DRUG

At visit V0, the investigational cream is applied once topically to the whole body. For patients who are not cured at visit V1, i.e. 14 days later, the application is repeated analogously once at this time.

5% Permethrin Creme

10% Permethrin Creme DRUG

At visit V0, the investigational cream is applied once topically to the whole body. For patients who are not cured at visit V1, i.e. 14 days later, the application is repeated analogously once at this time.

10% Permethrin Creme

Eligibility Criteria

• Age: 2 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 scabies-typical predilection sites
• Age between 2 years and 85 years
• Written informed consent of 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)
• Practicable application of the trial medication by trained specialist staff at the trial site

You may not qualify if:

• Pre-treatment with antiscabiosa in the last 14 days
• Combined antiscabial treatment (i.e. simultaneous/simultaneous topical and systemic scabies treatment with medication) in the last 3 months
• Known intolerance to permethrin, other pyrethroids, chrysanthemums or any of the other ingredients of the study medication
• Scabies crustosa
• Impetiginization/eczematization requiring inpatient treatment
• Body weight \> 120 kg
• Pregnancy, breastfeeding
• 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)
• Other serious illnesses which, in the opinion of the investigator, prevent the patient from participating in the study
• Planned systemic use of corticosteroids
• Planned or previous (last 4 weeks) use of systemic or cutaneous non-steroidal immunosuppressants
• Apparent unreliability or unwillingness to cooperate
• Inability to understand and comply with study instructions
• Known alcohol, medication or drug dependence
• Placement in a facility 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, or placement in an institution ordered by a court/authority

Sponsors & Collaborators

• Infectopharm Arzneimittel GmbH: lead
• Winicker Norimed GmbH: collaborator

MeSH Terms

Conditions

Scabies

Condition Hierarchy (Ancestors)

Mite Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Cord Sunderkötter, Prof. Dr.

  Universitätsklinik und Poliklinik für Dermatologie une Venerologie, Halle (Saale)

  STUDY DIRECTOR

Central Study Contacts

Bertil Wachall, Dr.

CONTACT

06252 95 7000; clinical.trials@infectopharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The SKABUP study is a prospective, randomized, double-blind, 2-arm superiority study in a group sequential design with recruitment stop and interim analysis after 172 patients. If there is no evidence of superiority in the interim analysis, the study will be continued unchanged up to the planned number of 220 patients and will be terminated and analyzed regularly.

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 23, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share