A single-center randomized, active-controlled, observer-blinded, parallel group trial to evaluate the efficacy and safety of a topical dimeticone formulation (Loion®) compared to 10% saliclylic acid in octyldodecanol with 15% Macrogol-4-laurylether in the removal of psoriatic plaques in patients with chronic psoriasis capitis (scalp psoriasis).

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2013
INTERVENTION: 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 Form: Cutaneous solution Other descriptive name: SALICYLIC ACID Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 100‐ CONDITION: 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 Therapeutic area: Diseases [C] ‐ Skin and Connective Tissue Diseases [C17] PRIMARY OUTCOME: 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).; Primary end point(s): ‐ Proportion of treatment responders in scaling (= = 0.5 points im‐provement); ; ; Secondary Objective: 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 OUTCOME: 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). 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
Epistemonikos ID: 4901d3bea29655c3e2ca9ee6331d503f02d8f589
First added on: Feb 15, 2022