Parallel Group Trial to Evaluate the Efficacy and Safety of Loion® Compared to 10% Salicylic Acid in Patients With Chronic Psoriasis Capitis

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: G. Pohl-Boskamp GmbH & Co. KG
• Collaborator: Universitätsklinikum Hamburg-Eppendorf
• Treatments: Salicylates; Salicylic Acid

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.