psoriatic plaques in patients with chronic psoriasis capitis MedDRA version: 14.1 Level: LLT Classification code 10037157 Term: Psoriasis of scalp System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Loion®
Product Name: Loion
Pharmaceutical Form: Cutaneous solution
Other descriptive name: DIMETICONE 100 CST
Product Name: Abwaschbares Salicylsäure-Öl 10 % (NRF 11.85.)
Pharmaceutical F
Sponsors
G. Pohl-Boskamp GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients = 18 years of age. - Having a diagnosis of chronic psoriasis capitis (scalp psoriasis) with or without the involvement of other body areas and with or without psoriatic arthritis. - PSSI =5 (range 0-72) - Scaling =2 (on an scale from 0 to 4) - At least 10% of scalp area affected - If a women: - Postmenopausal - Premenopausal and using an effective contraceptive device (e.g. oral contra-ceptives). - Negative pregnancy test at inclusion. - Patients with no concomitant systemic psoriasis medication. - Be willing and adhere to the prohibitions and restrictions specified in the study protocol. - Be willing to self-administer the drug. - Sign an informed consent document indicating that the patient to be included understands the purpose of and the procedures for the study and is willing to participate. 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: - Patients having a solely non- plaque form of psoriasis (e.g. erythrodermic, gut-tate, pustular). - Patients with uncontrolled psoriasis under the current treatment. - Patients having received topical keratolytic agents for the scalp in the past 2 weeks and topical steroids for the scalp in the past week prior to inclusion. - Patients receiving systemic antipsoriatic drugs, immunosuppresants or systemic corticosteroids (within 4 weeks prior to inclusion) - Women who are pregnant or breastfeeding or planning to become pregnant dur-ing the observational period - Patients participating in another study using an investigational agent or proce-dure during participation in the study observation period. - Known hypersensitivity to any ingredient in the investigational products’ formulations. - Having any condition that in the opinion of the investigator makes the participa-tion not be in the best interest of the subject - Employees and staff of the investigator or study site with direct involvement in the study as well as family members of the employee or the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy and safety of a topical dimeticone formulation (Loion®) compared 10% saliclylic acid in octyldodecanol with 15% Macrogol-4-laurylether for the removal of psoriatic plaques in patients with chronic psoriasis capitis (scalp psoriasis). ;Secondary Objective: ;Primary end point(s): - Proportion of treatment responders in scaling (= = 0.5 points im-provement) ;Timepoint(s) of evaluation of this end point: After 3±1, 7 and 14 days in comparison to baseline (determined directly before start of treatment). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Improvement of scaling by > 50% -sPGA -Mean value comparison of scaling after treatment -Comparison of the efficacy and safety of Loion® to SA-Gel (non-inferiority) -Amount of Loion® applied per application: in total and per representative defined target area -Time to treatment response;Timepoint(s) of evaluation of this end point: After 3±1, 7 and 14 days in comparison to baseline (determined directly before start of treatment). | — |
Countries
Germany
Contacts
Public ContactSaskia Borregaard
Clinical Trial Center North, MediGate GmbH
Outcome results
None listed