ScabiesPhase 3ETSKABINCT04814511
Escalated Therapy of Scabies With INFECTOSCAB 5% (Permethrin)
A Phase 3 study testing InfectoScab 5 % Creme, Permethrin 10 % Creme and Driponin 3 mg Tabletten in people with Scabies, run by Infectopharm Arzneimittel GmbH at 8 sites in Germany.
Trial summary
The ETSKABI study is a prospective, open-label, multicenter, initially single-armed and in case of treatment failure subsequently three-armed randomized clinical trial. Within the initial treatment phase, the to-date clinical efficacy of the standard therapy regimen according to the current German "S1-guideline for… Read more about this study
- Who is it for?
- Ages 6 to 85 years
- Conditions the study is for
- Scabies
- What is being tested?
- InfectoScab 5 % Creme, Permethrin 10 % Creme and Driponin 3 mg Tabletten
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 8 sitesGermany
- Study dates
- 11 Jun 2021to Aug 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 6 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 at scabies-typical predilection sites, detected by reflected light microscopy (dermatoscopy) or light microscopy of skin samples.
- Age between 6 and 85 years
- Written informed consent of the study participant (if of age) or of all guardians (in the case of study participants who are minors < 12 years of age) or of all guardians and the study participant (in the case of study participants who are minors ≥ 12 years of age).
Who cannot join
- Previous treatment with antiscabiosa in the last 14 days.
- Known intolerance to permethrin, other pyrethroids, chrysanthemum, ivermectin or any of the other ingredients of the study medication.
- Scabies crustosa
- Impetiginisation/eczematisation requiring in-patient treatment
- Body weight > 120 kg
- Pregnancy, lactation
Show all 17Show fewer
- Immunodeficiency (of any kind, including 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)
- Other serious illnesses which, in the opinion of the investigator, prevent the patient from participating in the study (including risk factors for severe COVID-19 disease in the case of SARS-CoV-2 infection).
- Planned systemic use of corticosteroids
- Planned or previous (last 4 weeks) use of systemic or cutaneous non-steroidal immunosuppressants
- Known or clinically suspected blood-brain barrier disruption (e.g. ABCB-1 (=MDR-1) mutation), and history of neurotoxic effects from ivermectin or other substrates/inhibitors of para-glycoprotein (P-gp)
- Apparent unreliability or unwillingness to cooperate.
- Inability to understand and comply with study instructions
- Known alcohol, medication or drug dependence
- Court/agency-ordered institutionalisation
- Dependence on sponsor or investigator
- Previous participation in a clinical trial within the last 30 days or in the same clinical trial
Trial locations and contacts
8 sites in 1 country.
Andreas Linke, Dr. contact
8 sites in 1 country
Germany8 sites, 8 recruiting
- Recruiting
Uniklinik RWTH Aachen
Aachen, 52074
Mark Neis, PD Dr.
Amir Yazdi, Prof. Dr.
- Recruiting
Universitätsklinikum Augsburg
Augsburg, 86179
Julia Welzel, Prof. Dr.
Kai-Uwe Krämer, Dr.
- Recruiting
Klinikum Darmstadt
Darmstadt, 64297
Maurizio Podda, Dr.
Maximilian Kovacs, Dr.
- Not yet recruiting
Städtisches Klinikum Dresden
Dresden, 01067
Uwe Wollina, Prof. Dr.
André Koch, Dr.
- Recruiting
Universitätsklinik und Poliklinik für Dermatologie und Venerologie
Halle, 06120
Cord Sunderkötter, Prof. Dr.
Johannes Wohlrab, Prof. Dr.
- Recruiting
Klinikum der Stadt Ludwigshafen
Ludwigshafen, 67063
Christoph Löser, Dr.
Edgar Dippel, Prof. Dr.
- Recruiting
Universitätsmedizin Rostock
Rostock, 18057
Rüdiger Panzer, Dr.
Susanne Krebs, Dr.
- Recruiting
Universitätsklinikum Würzburg
Würzburg, 97080
Johanna Stoevesandt, Dr.
Andreas Kerstan, Dr.
About this study
Official title: Prospective, Open-label, Multicenter, Initially Single-armed and in Case of Treatment Failure Subsequently Three-armed Randomized Clinical Trial of Phase III/IV Investigating the Escalated Therapy of Scabies With INFECTOSCAB 5% (Permethrin)
The ETSKABI study is a prospective, open-label, multicenter, initially single-armed and in case of treatment failure subsequently three-armed randomized clinical trial. Within the initial treatment phase, the to-date clinical efficacy of the standard therapy regimen according to the current German "S1-guideline for the diagnosis and treatment of scabies" is to be examined. The subsequent second phase focusses on three differently escalated treatment regimens in order to evaluate their potential to cure those patients still suffering from Scabies after standard therapy.
In total, 183 patients with Scabies who meet all inclusion criteria and do not meet none of the exclusion criteria are to be enrolled and topically treated with Permethrin 5 % cream (up to two administrations, i.e. repeated one-time on day 14 in case of persisting Scabies). In case of treatment failure by the end of phase one, adult patients will be randomized to either receive an (i) escalated therapy with Permethrin 5 % cream (repeated topical administration on two consecutive days), (ii) an add-on-combination consisting of escalated therapy with Permethrin 5 % cream and Ivermectin p.o. or (iii) an escalated therapy with Permethrin 10 % cream (up to two administrations, i.e. repeated one-time on day 14 in case of persisting Scabies).
The primary objective of the ETSKABI study is the clinical efficacy of the standard therapy by the end of phase one (standard therapy according to the S1-guideline). Beside this, clinical efficacy by the end of phase two (escalation phase) will be evaluated as well as adverse events in order to investigate over-all clinical safety.
- Conditions
- Scabies
- Being tested
- InfectoScab 5 % Creme, Permethrin 10 % Creme, Driponin 3 mg Tabletten
- Medical subject headings
- Scabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfectoScab 5 % CremeDrug
InfectoScab 5 % Creme is the already approved standard therapeutic agent, containing the active ingredient permethrin in 5 % concentration. In this study, it is used for topical treatment in the first treatment cycle (standard therapy) as well as in the second treatment cycle (escalation therapy).
Permethrin 10 % CremeDrug
Permethrin 10 % Creme also contains permethrin as the active ingredient, but in 10 % concentration. Permethrin 10 % creme is used exclusively for topical treatment in the second therapy cycle (escalation therapy).
Driponin 3 mg TablettenDrug
Driponin 3 mg Tabletten are approved for the treatment of scabies, containing ivermectin as the active ingredient. Driponin is used as a supplementary, peroral add-on combination treatment in addition to topical permethrin therapy and is used exclusively in the second treatment cycle (escalation therapy).
| Study group | Role | What they receive |
|---|---|---|
| Standard therapy with InfectoScab 5 % Creme | Other | Not described Receives: Drug: InfectoScab 5 % Creme |
| Escalated therapy with InfectoScab 5 % Creme (arm E5) | Experimental | Not described Receives: Drug: InfectoScab 5 % Creme |
| Escalated therapy with Permethrin 10 % Creme (arm E10) | Experimental | Not described Receives: Drug: Permethrin 10 % Creme |
| Escalated therapy with InfectoScab 5 % Creme in combination with Driponin 3 mg Tabletten (arm EK) | Experimental | Not described Receives: Drug: InfectoScab 5 % Creme; Drug: Driponin 3 mg Tabletten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy (Yes/No)
Efficacy (Yes/No) after completed standard therapy treatment cycle (InfectoScab 5 % Creme, up to two administrations, if necessary), i.e. treatment success on day 14 (one administration) or on day 28 (one readministration due to persisting Scabies on day 14).
Treatment success is defined as:
- absence of new scabietic skin lesions, AND
- all remaining scabietic lesions are in healing, AND
- exclusion of mite infestation in all non-healed efflorescences by reflected light microscopy (dermatoscope), possibly confirmed by microscopic examination of a skin sample, AND
- exclusion of the usage of other anti-scabietic drugs
Measured: day 0 - day 28
Secondary outcomes (12)
Efficacy (treatment success) for VS1 and VS2, as well as for the corresponding follow-up visits FUS1 and FUS2 (separately and cumulatively).
Measured: day 14 - day 70
Efficacy (therapy success) for VE5, VE101/2 (separately and cumulatively) and VEK as well as for the corresponding follow-up visits FUE5/E10/EK, separately as well as cumulatively according to visit type (regular visit, FU visit)
Measured: day 28 - day 70
Cumulative efficacy (treatment success) of permethrin-only treatment (i.e. without combined escalation permethrin + ivermectin) by visit type (regular visit, FU visit)
Measured: day 28 - day 56
Frequency of required repeated standard therapy as well as escalated therapy.
Measured: day 0 - day 70
Itch (numerical rating scale (NRS) of 0-10) and change in itch vs baseline (scale differences) for all visits, for standard therapy and escalated therapy, and for escalated therapy additionally the change in itch vs start of escalated therapy.
Measured: day 0 - day 70
Number and type of body regions affected (wrists/hands, arm pouches, armpits, genital region, groin, knee, feet/ankles/lower legs, head, torso, other) for all visits.
Measured: day 0 - day 70
Proportion of patients (in %) with evidence of mites (incl. nymphs and larvae, reflecting light microscopy (dermatoscope) or light microscopy of skin samples) for all visits, for standard therapy and escalated therapy
Measured: day 0 - day 70
Proportion of patients with use of antiscabiosa not conforming to study procedures for all visits, for standard therapy and escalated therapy
Measured: day 0 - day 70
Proportion of patients with new scabies efflorescences for all treatment cycles and control visits
Measured: day 0 - day 70
Patients with "additionally confirmed" therapy failure (in %)
Proportion of patients with new scabies efflorescences at the end of standard therapy or escalated therapy 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 procedure during the respective therapy cycle.
Measured: day 0 - day 70
Patients with reinfestation (in %): Proportion of patients with microscopically confirmed new efflorescences at the end of standard therapy or escalated therapy (respective FU-visit) who were assessed as cured at the immediately preceding control visit.
Measured: day 0 - day 70
Adverse events, serious adverse events, unexpected drug reactions, serious unexpected drug reactions (total frequency, type, severity, causality, with frequencies, with separate presentation of local reactions).
Measured: day 0 - day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start11 Jun 2021
- Primary completionDec 2022 (estimated)
- Study completionAug 2023 (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
- Sequential
- Masking
- None (open label)
- Enrolment
- 183 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., Principal investigator, Universitätsklinik und Poliklinik für Dermatologie und Venerologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814511
- Sponsor's protocol ID
- ETSKABI
- Other IDs
- 2019-003234-16, 2019
- Acronym
- ETSKABI
- Status last verified
- Aug 2021
- First submitted
- 22 Mar 2021
- Last updated
- 26 Aug 2021
- 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 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open-label, Multicenter, Initially Single-armed and in Case of Treatment Failure Subsequently Three-armed Randomized Clinical Trial of Phase III/IV Investigating the Escalated Therapy of Scabies With INFECTOSCAB 5% (Permethrin)
- ClinicalTrials.gov ID
- NCT04814511
- Acronym / sponsor ID
- ETSKABI / ETSKABI
- Conditions
- Scabies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 183 participants (estimated)
- Lead sponsor
- Infectopharm Arzneimittel GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Winicker Norimed GmbH
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 24 Mar 2021 (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 ETSKABI study is a prospective, open-label, multicenter, initially single-armed and in case of treatment failure subsequently three-armed randomized clinical trial. Within the initial treatment phase, the to-date clinical efficacy of the standard therapy regimen according to the current German "S1-guideline for the diagnosis and treatment of scabies" is to be examined. The subsequent second phase focusses on three differently escalated treatment regimens in order to evaluate their potential to cure those patients still suffering from Scabies after standard therapy.
In total, 183 patients with Scabies who meet all inclusion criteria and do not meet none of the exclusion criteria are to be enrolled and topically treated with Permethrin 5 % cream (up to two administrations, i.e. repeated one-time on day 14 in case of persisting Scabies). In case of treatment failure by the end of phase one, adult patients will be randomized to either receive an (i) escalated therapy with Permethrin 5 % cream (repeated topical administration on two consecutive days), (ii) an add-on-combination consisting of escalated therapy with Permethrin 5 % cream and Ivermectin p.o. or (iii) an escalated therapy with Permethrin 10 % cream (up to two administrations, i.e. repeated one-time on day 14 in case of persisting Scabies).
The primary objective of the ETSKABI study is the clinical efficacy of the standard therapy by the end of phase one (standard therapy according to the S1-guideline). Beside this, clinical efficacy by the end of phase two (escalation phase) will be evaluated as well as adverse events in order to investigate over-all clinical safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard therapy with InfectoScab 5 % Creme | Other | Drug: InfectoScab 5 % Creme |
| Escalated therapy with InfectoScab 5 % Creme (arm E5) | Experimental | Drug: InfectoScab 5 % Creme |
| Escalated therapy with Permethrin 10 % Creme (arm E10) | Experimental | Drug: Permethrin 10 % Creme |
| Escalated therapy with InfectoScab 5 % Creme in combination with Driponin 3 mg Tabletten (arm EK) | Experimental | Drug: InfectoScab 5 % Creme, Drug: Driponin 3 mg Tabletten |
Who may qualify
- Ages
- 6 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed acute scabies disease: detection of mites and/or mite nymphs and/or mite larvae at scabies-typical predilection sites, detected by reflected light microscopy (dermatoscopy) or light microscopy of skin samples.
- Age between 6 and 85 years
- Written informed consent of the study participant (if of age) or of all guardians (in the case of study participants who are minors < 12 years of age) or of all guardians and the study participant (in the case of study participants who are minors ≥ 12 years of age).
Key exclusion criteria (17 listed)
- Previous treatment with antiscabiosa in the last 14 days.
- Known intolerance to permethrin, other pyrethroids, chrysanthemum, ivermectin or any of the other ingredients of the study medication.
- Scabies crustosa
- Impetiginisation/eczematisation requiring in-patient treatment
- Body weight > 120 kg
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 |
|---|---|---|
| InfectoScab 5 % CremeInfectoScab 5 % Creme is the already approved standard therapeutic agent, containing the active ingredient permethrin in 5 % concentration. In this study, it is used for topical treatment in the first treatment cycle (standard therapy) as well as in the second treatment cycle (escalation therapy). | Drug | Escalated therapy with InfectoScab 5 % Creme (arm E5), Escalated therapy with InfectoScab 5 % Creme in combination with Driponin 3 mg Tabletten (arm EK), Standard therapy with InfectoScab 5 % Creme |
| Permethrin 10 % CremePermethrin 10 % Creme also contains permethrin as the active ingredient, but in 10 % concentration. Permethrin 10 % creme is used exclusively for topical treatment in the second therapy cycle (escalation therapy). | Drug | Escalated therapy with Permethrin 10 % Creme (arm E10) |
| Driponin 3 mg TablettenDriponin 3 mg Tabletten are approved for the treatment of scabies, containing ivermectin as the active ingredient. Driponin is used as a supplementary, peroral add-on combination treatment in addition to topical permethrin therapy and is used exclusively in the second treatment cycle (escalation therapy). | Drug | Escalated therapy with InfectoScab 5 % Creme in combination with Driponin 3 mg Tabletten (arm EK) |
Primary outcome
Efficacy (Yes/No)
Time frame: day 0 - day 28
Efficacy (Yes/No) after completed standard therapy treatment cycle (InfectoScab 5 % Creme, up to two administrations, if necessary), i.e. treatment success on day 14 (one administration) or on day 28 (one readministration due to persisting Scabies on day 14). Treatment success is defined as: * absence of new scabietic skin lesions, AND * all remaining scabietic lesions are in healing, AND * exclusion of mite infestation in all non-healed efflorescences by reflected light microscopy (dermatoscope), possibly confirmed by microscopic examination of a skin sample, AND * exclusion of the usage of other anti-scabietic drugs
12 secondary outcomes
Efficacy (treatment success) for VS1 and VS2, as well as for the corresponding follow-up visits FUS1 and FUS2 (separately and cumulatively).
Time frame: day 14 - day 70
Efficacy (therapy success) for VE5, VE101/2 (separately and cumulatively) and VEK as well as for the corresponding follow-up visits FUE5/E10/EK, separately as well as cumulatively according to visit type (regular visit, FU visit)
Time frame: day 28 - day 70
Cumulative efficacy (treatment success) of permethrin-only treatment (i.e. without combined escalation permethrin + ivermectin) by visit type (regular visit, FU visit)
Time frame: day 28 - day 56
Frequency of required repeated standard therapy as well as escalated therapy.
Time frame: day 0 - day 70
Itch (numerical rating scale (NRS) of 0-10) and change in itch vs baseline (scale differences) for all visits, for standard therapy and escalated therapy, and for escalated therapy additionally the change in itch vs start of escalated therapy.
Time frame: day 0 - day 70
Number and type of body regions affected (wrists/hands, arm pouches, armpits, genital region, groin, knee, feet/ankles/lower legs, head, torso, other) for all visits.
Time frame: day 0 - day 70
Proportion of patients (in %) with evidence of mites (incl. nymphs and larvae, reflecting light microscopy (dermatoscope) or light microscopy of skin samples) for all visits, for standard therapy and escalated therapy
Time frame: day 0 - day 70
Proportion of patients with use of antiscabiosa not conforming to study procedures for all visits, for standard therapy and escalated therapy
Time frame: day 0 - day 70
Proportion of patients with new scabies efflorescences for all treatment cycles and control visits
Time frame: day 0 - day 70
Patients with "additionally confirmed" therapy failure (in %)
Time frame: day 0 - day 70
Patients with reinfestation (in %): Proportion of patients with microscopically confirmed new efflorescences at the end of standard therapy or escalated therapy (respective FU-visit) who were assessed as cured at the immediately preceding control visit.
Time frame: day 0 - day 70
Adverse events, serious adverse events, unexpected drug reactions, serious unexpected drug reactions (total frequency, type, severity, causality, with frequencies, with separate presentation of local reactions).
Time frame: day 0 - day 70
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- 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. This study is not recruiting at the moment.
Andreas Linke, Dr. contact
Cord Sunderkötter, Prof. Dr. principal investigator
Universitätsklinik und Poliklinik für Dermatologie und Venerologie
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing InfectoScab 5 % Creme, Permethrin 10 % Creme and Driponin 3 mg Tabletten in people with Scabies, run by Infectopharm Arzneimittel GmbH at 8 sites in Germany.
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 3 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Linke, Dr. (studien@infectopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (Yes/No) (time frame: day 0 - 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 26 Aug 2021.