The product is intended to be used by patients suffering from scabies infestation MedDRA version: 9.1 Level: LLT Classification code 10039512 Term: Scabies infestation
Conditions
Interventions
Product Name: pedimitex creme 5%
Pharmaceutical Form: Cream
INN or Proposed INN: Permethrin
CAS Number: 52645-53-1
Concentration unit: % (W/W) percent weight/weight
Concentration number: 5-
Sponsors
gepepharm GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · gender: male/female · age: = 2 months of age · acute case of scabies · the patient or his/her legal representative must give written informed consent, after having been oral and written informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the subjects participating in the study Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · known allergic reactions to the active ingredient used or to constituents of the pharmaceutical preparation, as well as chrysanthemum and other composite plants · crusted (Norwegian) scabies · subjects with known skin allergies or multiple drug allergies · patient underwent treatment with any permethrin-containing scabicidal agent within the last 4 weeks · patients with chronic skin disorder · pregnant or breast feeding women · female patients who do not agree to apply adequate contraceptive methods as defined in Note for Guidance on Non-Clinical Safety Studies for the Conduct of Human Clincal Trials for Pharmaceuticals (CPMP/ICH/286/95, modification), November 2000 (e.g. uterine tube sterilisation, sexual abstinence or vasectomised partner or combination of anti-conceptive medication with condom and spermicidal products, diaphragm, temperature method, and some IUDs)· patients suspected or known not to follow instructions · patients or his/her legal representative who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study · previous participation in this study or participation in any other drug investigational trial within the preceding 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of local tolerability;Secondary Objective: Assessment of global tolerability (by the investigator and by the patient), Assessment of skin itching using a visual analogue scale score, Assessment of systemic exposure (concentration of permethrin metabolite CVA in urine, descriptive evaluation), Characterisation of safety and tolerability by assessment of Adverse Events, Assessment of efficacy according to the cure rate;Primary end point(s): Assessment of local tolerability (subjective symptoms, descriptive evaluation) | — |
Countries
Bulgaria
Outcome results
None listed