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

Phase 2

Completed

• Conditions: Scalp Psoriasis
• Interventions: Drug: Salicylic Acid; Drug: Dimethicone

• Registration Number: NCT01914627
• Lead Sponsor: G. Pohl-Boskamp GmbH & Co. KG

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-17
• Study First Submitted QC: 2013-07-30
• Study Start: 2013-08
• Study First Posted: 2013-08-02
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-02
• Last Update Submitted: 2014-11-04
• Last Update Posted: 2014-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SA-Gel	Salicylic Acid	-
Loion	Dimethicone	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Scaling	at Day 7	To evaluate improvement of scaling of patients exposed to Loion or standard therapy for psoriasis capitis

Secondary Outcome Measures

Name	Time	Method
Psoriasis Scalp Severity Index (PSSI)	at Day 0, day 3, day 7, day 14	To evaluate clinical outcome of patients exposed to Loion or standard therapy for psoriasis capitis

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf (UKE); 🇩🇪 Hamburg, Germany