Status:
COMPLETED
Parallel Group Trial to Evaluate the Efficacy and Safety of Loion® Compared to 10% Salicylic Acid in Patients With Chronic Psoriasis Capitis
Lead Sponsor:
G. Pohl-Boskamp GmbH & Co. KG
Collaborating Sponsors:
Universitätsklinikum Hamburg-Eppendorf
Conditions:
Scalp Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 r...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01914627
Start Date
August 1 2013
End Date
January 1 2014
Last Update
November 5 2014
Active Locations (1)
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1
University Medical Center Hamburg-Eppendorf (UKE)
Hamburg, Germany, 20246