Psoriasis capitis MedDRA version: 14.1 Level: LLT Classification code 10037157 Term: Psoriasis of scalp System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Diprosalic Lösung
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: BETAMETHASONE DIPROPIONATE
CAS Number: 5593-20-4
Concentration unit: % (W/W) percent weight/weight
Concentrat
Sponsors
Dermapharm AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men or women, 18 years or older. 2) Written consent form. 3) Diagnosis: Psoriasis of the scalp. 4) At least 20% of the scalp affected. 5) Less than 50% of the body surface affected. 6) Less then 30 % of the body surface affected if the dermatosis was progressive within the last 4 weeks. 7) Activity parameter erythema, desquamation, thickening and pruritus (Score 0 to 3): Sum score equal to or more than 6 AND desquamation and erythema equal to or more than 4 AND desquamation equal to or more than 2. 8) Women of child bearing potential: Use of a highly effective method of contraception during the whole course of the study. 9) Negative pregnancy test prior to study start. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 225 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Systemtic psoriasis therapy within 4 weeks prior to screening. 2) Topical treatment or other therapies (e. g. UV exposure) of the psoriasis capitis within 2 weeks prior to screening. 3) Known intolerance or hypersensitivity against betamethasone, salicylic acid or other components of the vehicle. 4) Severe heart failure, severe insufficiency of the circulatory system, severe hepatic or renal insufficiency, severe respiratory insufficiency, neoplasm. 5) Severe acute or chronic concomitant disease seriously affecting the general condition. 6) Concomitant diseases which may - taking the present knowledge into account - influence the parameters evaluated in the study in a way that an objective evaluation would be impossible. 7) Concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data. 8) Well-founded doubt on the co-operation of the patient. 9) Dementia or other severe intellectual problems, that make evaluation of patient history or self-assessment of the patient impossible. 10) Excessive use of alcohol, drugs, medication or nicotine. 11) Participation of the patient in another clinical trial within the last 30 days prior to inclusion or during this study. 12) Former participation of the patient in this clinical trial. 13) Pregnant women or planned pregnancy or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the efficacy and safety of a new 0,05% betamethasone 2% salicylic acid solution vs. the originator Diprosalic (licensed) vs. vehicle in patients with psoriasis of the scalp. ;Secondary Objective: The following parameters are definded as secondary in the study protocol: Course of the single parameters erythema, desquamation, thickening of the skin and pruritus and the sum score between screening (day 0) and final examination or early termination. Percentage of patients without symptoms (sum score = 0) at end of therapy and at the end of the observation phase. Global evaluation of therapeutic success by the investigator and the patient in the course of the study. ;Primary end point(s): The primary efficacy parameter of this study is the difference of the sum score between start of therapy and end of therapy. The sum score consits of the activity parameters erythema, desquamation, thickening of the skin and pruritus. ;Timepoint(s) of evaluation of this end point: Start of therapy (day 0) and end of therapy (day 21). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following parameters are definded as secondary in the study protocol: Course of the single parameters erythema, desquamation, thickening of the skin and pruritus and the sum score between screening (day 0) and final examination or early termination. Percentage of patients without symptoms (sum score = 0) at end of therapy and at the end of the observation phase. Global evaluation of therapeutic success by the investigator and the patient.;Timepoint(s) of evaluation of this end point: Day 0, day 7, day 14, day 21 and day 35. | — |
Countries
Germany
Contacts
Public ContactHead of clinical department
Dermapharm AG
Outcome results
None listed