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

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 Overview

• Status: Completed
• Conditions: Scalp Psoriasis
• Intervention / Treatment: Drug: Dimethicone; Drug: Salicylic Acid

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • University Medical Center Hamburg-Eppendorf (UKE)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Loion	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.
Active Comparator: SA-Gel	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psoriasis Area Severity Index (PASI)	To evaluate clinical outcome of patients exposed to Loion or standard therapy for psoriasis capitis	at Day 0, day 3, day 7, day 14
Body Surface Area (BSA)	To evaluate clinical outcome of patients exposed to Loion or standard therapy for psoriasis capitis	at Day 0, day 3, day 7, day 14
Physician Global Assessment (PGA)	To evaluate global severity of skin of patients exposed to Loion or standard therapy for psoriasis capitis	at Day 0, day 3, day 7, day 14
Scalp Physician Global Assessment (sPGA)	To evaluate global severity of scalp skin of patients exposed to Loion or standard therapy for psoriasis capitis	at Day 0, day 3, day 7, day 14
Dermatology Life Quality Index (DLQI)	To evaluate disease related quality of life of patients exposed to Loion or standard therapy for psoriasis capitis	at Day 0, day 3, day 7, day 14
Patient Benefit Index (PBI)	To evaluate the patient benefit of Loion or standard therapy for psoriasis capitis	at Day 0, day 3, day 7, day 14
EuroQol Questionnaire (EQ-5D)	To evaluate general state of health of patients exposed to Loion or standard therapy for psoriasis capitis	at Day 0, day 3, day 7, day 14
Adverse and serious adverse events	Risk for adverse events and serious adverse events for patients exposed to Loion or standard therapy for psoriasis capitis	14 days

Collaborators and Investigators

• Sponsor: G. Pohl-Boskamp GmbH & Co. KG
• Collaborators: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Matthias Augustin, Prof., University Medical Center Hamburg-Eppendorf (UKE)

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: July 17, 2013
• First Submitted That Met QC Criteria: July 30, 2013
• First Posted (Estimate): August 2, 2013

Study Record Updates

• Last Update Posted (Estimate): November 5, 2014
• Last Update Submitted That Met QC Criteria: November 4, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Salicylic acid; Psoriasis capitis; Scaling; Dimethicone; Plaque removal
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Dermatologic Agents; Antifungal Agents; Keratolytic Agents; Salicylic Acid; Salicylates
• Other Study ID Numbers: 0741/179