ScabiesPhase 3SKABUPNCT06380452
Therapy for Scabies With Two Differently Concentrated Permethrin Creams
A Phase 3 study testing 5% Permethrin Creme and 10% Permethrin Creme in people with Scabies, run by Infectopharm Arzneimittel GmbH.
Trial 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%. Read more about this study
- Who is it for?
- Ages 2 to 85 years
- Conditions the study is for
- Scabies
- What is being tested?
- 5% Permethrin Creme and 10% Permethrin Creme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
- 5 or more close contacts (persons with close, extensive skin-to-skin contact with the scabies patient for more than 5-10 minutes)
- Close contact person who refuses scabies treatment or for whom treatment is not possible
- Dependence on sponsor or investigator
- Previous participation in a clinical trial in the last 30 days or in the same clinical trial
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase III Multicenter, Prospective, Randomized, Double-blind Study Comparing the Efficacy and Safety of Therapy for Scabies With Two Differently Concentrated Permethrin Creams.
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%.
Read the detailed description
The SKABUP study is a multi-center, prospective, randomized, double-blind phase III clinical trial. The aim of this SKABUP study is to compare the efficacy and safety of topical therapy with permethrin 5% and permethrin 10% in a multicenter randomized double-blind setting in order to demonstrate the possible superiority of the 10% permethrin cream over the current standard therapy with permethrin 5% cream. In order to demonstrate a possible difference in efficacy as clearly as possible, the study will be conducted in dermatology clinics and without extensive exclusion of previous therapies in the patient's medical history.
The primary objective of the SKABUP study is the clincal 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 application of investigational product) or on day 28 (for study participants with repeated application of investigational product).
A total of 220 scabies patients aged between 2 and 85 years are to be included in the study (clinical trial). After 172 patients, however, recruitment will be stopped and an interim evaluation carried out. If there is proof of superiority, the study will be terminated; if there is no proof of superiority, it will be continued unchanged. Study drop-outs, i.e. patients included in the study with at least one application of an investigational product whose participation in the study ends prematurely, will not be replaced.
- Conditions
- Scabies
- Being tested
- 5% Permethrin Creme, 10% Permethrin Creme
- Medical subject headings
- Scabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% Permethrin CremeDrug
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 CremeDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 10% Permethrin Creme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: day 14 - day 28
Secondary outcomes (8)
effectiveness at Visit 1
therapy success at Visit 1
Measured: day 14
frequency of therapy success
frequency of therapy success after only one application in relation to the overall frequency of therapy success (after completion of treatment)
Measured: day 0 - day 28
itching
itching (Numerical Rating Scale (NRS) from 0-10) and change in itching vs. baseline (scale differences) for all visits
Measured: day 0 - day 28
patients with evidence of mites
proportion of patients (in %) with evidence of mites (incl. nymphs and larvae, reflected light microscopy or light microscopy of skin samples) for all visits
Measured: day 0 - day 28
patients with use of antiscabiosa not compliant with the protocol
proportion of patients with use of antiscabiosa not compliant with the study protocol for all visits
Measured: day 0 - day 28
patients with new scabies efflorescences
Proportion of patients with new scabies efflorescences for all visits
Measured: day 0 - day 28
patients with "additional confirmed" treatment failure
patients with "additional confirmed" treatment failure (in %): Proportion of patients with new scabies efflorescences at the end of treatment OR with mite detection by microscopic examination of a skin sample OR use of other antiscabio-sa not conforming to the study protocol
Measured: day 0 - day 28
AEs, SAEs, ADRs, SUAWs
AEs, SAEs, ADRs, SUAWs (total frequency, type, severity, causality, with frequencies, with separate presentation of local reactions)
Measured: day 0 - day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study startMay 2024 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScabiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Infectopharm Arzneimittel GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Winicker Norimed GmbH
- Responsible party
- Sponsor
- Investigators
- Cord Sunderkötter, Prof. Dr., Study director, Universitätsklinik und Poliklinik für Dermatologie une Venerologie, Halle (Saale)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380452
- Sponsor's protocol ID
- SKABUP
- Other IDs
- 2023-507925-41-00, 2023
- Acronym
- SKABUP
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Multicenter, Prospective, Randomized, Double-blind Study Comparing the Efficacy and Safety of Therapy for Scabies With Two Differently Concentrated Permethrin Creams.
- ClinicalTrials.gov ID
- NCT06380452
- Acronym / sponsor ID
- SKABUP / SKABUP
- Conditions
- Scabies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Infectopharm Arzneimittel GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Winicker Norimed GmbH
- Study start
- May 2024 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Detailed description
The SKABUP study is a multi-center, prospective, randomized, double-blind phase III clinical trial. The aim of this SKABUP study is to compare the efficacy and safety of topical therapy with permethrin 5% and permethrin 10% in a multicenter randomized double-blind setting in order to demonstrate the possible superiority of the 10% permethrin cream over the current standard therapy with permethrin 5% cream. In order to demonstrate a possible difference in efficacy as clearly as possible, the study will be conducted in dermatology clinics and without extensive exclusion of previous therapies in the patient's medical history.
The primary objective of the SKABUP study is the clincal 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 application of investigational product) or on day 28 (for study participants with repeated application of investigational product).
A total of 220 scabies patients aged between 2 and 85 years are to be included in the study (clinical trial). After 172 patients, however, recruitment will be stopped and an interim evaluation carried out. If there is proof of superiority, the study will be terminated; if there is no proof of superiority, it will be continued unchanged. Study drop-outs, i.e. patients included in the study with at least one application of an investigational product whose participation in the study ends prematurely, will not be replaced.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 5% Permethrin Creme | Active comparator | Drug: 5% Permethrin CremePermethrin 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. |
| 10% Permethrin Creme | Experimental | Drug: 10% Permethrin CremePermethrin 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. |
Who may qualify
- Ages
- 2 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5% Permethrin CremeAt 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. | Drug | 5% Permethrin Creme |
| 10% Permethrin CremeAt 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. | Drug | 10% Permethrin Creme |
Primary outcome
clinical efficacy (yes/no)
Time frame: day 14 - day 28
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).
8 secondary outcomes
effectiveness at Visit 1
Time frame: day 14
frequency of therapy success
Time frame: day 0 - day 28
itching
Time frame: day 0 - day 28
patients with evidence of mites
Time frame: day 0 - day 28
patients with use of antiscabiosa not compliant with the protocol
Time frame: day 0 - day 28
patients with new scabies efflorescences
Time frame: day 0 - day 28
patients with "additional confirmed" treatment failure
Time frame: day 0 - day 28
AEs, SAEs, ADRs, SUAWs
Time frame: day 0 - day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cord Sunderkötter, Prof. Dr. study director
Universitätsklinik und Poliklinik für Dermatologie une Venerologie, Halle (Saale)
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5% Permethrin Creme and 10% Permethrin Creme in people with Scabies, run by Infectopharm Arzneimittel GmbH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bertil Wachall, Dr. (06252 95 7000, clinical.trials@infectopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical efficacy (yes/no) (time frame: day 14 - day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.