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

NCT ID: NCT01914627

Last Updated: 2014-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-01-31

Brief 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).

Conditions

Scalp Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Loion

Group Type: EXPERIMENTAL

Dimethicone

Intervention Type: DRUG

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.

SA-Gel

Group Type: ACTIVE_COMPARATOR

Salicylic Acid

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: collaborator

G. Pohl-Boskamp GmbH & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthias Augustin, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Hamburg-Eppendorf (UKE)

Locations

University Medical Center Hamburg-Eppendorf (UKE)

Hamburg, , Germany

Countries

Germany

Other Identifiers

0741/179

Identifier Type: -

Identifier Source: org_study_id