Trial | NCT01914627  Report issue

Title

Parallel Group Trial to Evaluate the Efficacy and Safety of Loion® Compared to 10% Salicylic Acid in Patients With Chronic Psoriasis Capitis
A Single-centre Randomised, Active-controlled, Observer-blinded, Parallel Group Trial to Evaluate the Efficacy and Safety of a Topical Dimeticone Formulation (Loion®) Compared to 10% Salicylic Acid in the Removal of Scaling in Patients With Chronic Psoriasis Capitis

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    90
The study will be conducted to evaluate the efficacy and safety of a topical dimeticone formulation (Loion®) compared to 10% salicylic acid in octyl-dodecanol with 15% Macrogol-4-laurylether for the removal of scaling in patients with chronic psoriasis capitis (scalp psoriasis).
Study Started
Aug 31
2013
Primary Completion
Jan 31
2014
Study Completion
Jan 31
2014
Last Update
Nov 05
2014
Estimate

Drug Dimethicone

The treatment will be carried out once daily (in the evening) onto all scaling areas of the scalp over a period of 2 weeks, with the last application of investigational products being applied one day prior to the final visit.

Drug Salicylic Acid

The treatment will be carried out once daily (in the evening) onto all scaling areas of the scalp over a period of 2 weeks, with the last application of investigational products being applied one day prior to the final visit.

Loion Experimental

SA-Gel Active Comparator

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 established oral, injected or implanted hormonal method of contraception, intrauterine device (IUD) or intrauterine system (IUS)
Negative pregnancy test at inclusion
Patients with no concomitant systemic psoriasis medication.
Willingness and adherence to the prohibitions and restrictions specified in the study protocol.
Willingness to self-administer the drug.
Signed 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.

Exclusion Criteria:

Patients having a solely non- plaque form of psoriasis (e.g. erythrodermic, guttate, pustular).
Patients with uncontrolled psoriasis under the current treatment.
Patients having received topical keratolytic agents for the scalp within the past 2 weeks and topical steroids for the scalp within the past week (prior to inclusion).
Patients receiving systemic antipsoriatic drugs, immunosuppressants or systemic corticosteroids (within 4 weeks prior to inclusion).
Women who are pregnant or breastfeeding or planning to become pregnant during the observational period.
Patients participating in another study using an investigational agent or procedure 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 participation 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.
No Results Posted