NCT01914627CompletedPhase 2
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
G. Pohl-Boskamp GmbH & Co. KG1 site in 1 country90 target enrollmentStarted: August 2013Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Change from Baseline in Scaling
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Loion
Experimental
Intervention: Dimethicone (Drug)
SA-Gel
Active Comparator
Intervention: Salicylic Acid (Drug)
Outcomes
Primary Outcomes
Change from Baseline in Scaling
Time Frame: at Day 7
To evaluate improvement of scaling of patients exposed to Loion or standard therapy for psoriasis capitis
Secondary Outcomes
- Psoriasis Scalp Severity Index (PSSI)(at Day 0, day 3, day 7, day 14)
Investigators
Study Sites (1)
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