Health TrialsbyHealthPanel

Therapy for Scabies With Two Differently Concentrated Permethrin Creams

ConditionScabies
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-85
SponsorInfectopharm Arzneimittel GmbH

About this trial

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%.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: 5% Permethrin CremeActive comparator 1 intervention
Group B: 10% Permethrin CremeExperimental treatment 1 intervention

Trial outcomes

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).

Time frame
day 14 - day 28

Secondary outcomes

1

effectiveness at Visit 1

therapy success at Visit 1

Time frame
day 14
2

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)

Time frame
day 0 - day 28
3

itching

itching (Numerical Rating Scale (NRS) from 0-10) and change in itching vs. baseline (scale differences) for all visits

Time frame
day 0 - day 28
4

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

Time frame
day 0 - day 28

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Infectopharm Arzneimittel GmbH

Lead sponsor

Winicker Norimed GmbH

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: