Patients with stable plaque-type psoriasis with plaques of sufficient size of at least 2 cm in diameter for five comparable treatment areas MedDRA version: 9.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris
Conditions
Interventions
Product Name: Riluzol 4 % Cream
Product Code: N07XX02
Pharmaceutical Form: Cream
INN or Proposed INN: Riluzole
CAS Number: 1744-22-5
Concentration unit: % percent
Concentration type: equal
Concentrati
Sponsors
Biofrontera Bioscience GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Ability to understand the nature of the study and the study-related procedures; • Willingness and ability to sign the Informed Consent Form and comply with any study-relevant regulations; • At least 18 years of age; • Stable plaque-type psoriasis with plaques of at least 2 cm in diameter at five comparable treatment areas, which are separated from each other by at least 2 cm for occluded and by at least 5 cm for non-occluded treatment areas; • Symptom sum score of at least 6 for each treatment area, i.e. a minimum score of 2 for each of the three clinical symptoms erythema, induration and scaling; • Stable general health condition in discretion of the investigator. Are the trial subjects under 18? no 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 allergy or hypersensitivity to the active pharmaceutical ingredient riluzole, to any of the excipients used in the vehicle or to the active pharmaceutical ingredient and/or excipients used in the positive control Betnesol®-V cream 0.1%; • Liver disease or transaminase values > 2 times upper normal limit (UNL); • Total bilirubin above the upper normal limit; • Renal impairment, characterized by a glomerular filtration rate (GFR) < 60 ml/min (calculated by using the modification of diet in renal disease (MDRD) formula.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective for efficacy of this study is to assess the antipsoriatic efficacy of a topical riluzole formulation (BF-37 cream 4%) in patients with stable psoriatic plaques in an intraindividual comparison vs. vehicle and an active control. The efficacy will be assessed by clinical scoring of the symptoms erythema, induration, and scaling in a Psoriasis Plaque Test. ;Secondary Objective: The secondary objective for efficacy of this study is to measure the skin redness at the treatment areas with a colormeter. In addition, the skin condition will be documented photographically. These photographs are for documentation only and will not be included in any trial-specific data analysis. A further secondary objective is to evaluate the safety/tolerability of the topical riluzole formulation by documenting local skin reactions, adverse events and safety laboratory assessments. ;Primary end point(s): Clinical score of the psoriatic lesions for the symptoms erythema, induration, and scaling | — |
Countries
Germany
Outcome results
None listed