Clinical trial NCT01914627: Parallel Group Trial to Evaluate the Efficacy and Safety of Loion® Compared to 10% Salicylic Acid in Patients With Chronic Psoriasis Capitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Scalp Psoriasis
Keywords: Psoriasis capitis
Scaling
Salicylic acid
Dimethicone
Plaque removal
Lead sponsor: G. Pohl-Boskamp GmbH & Co. KG
Sponsor class: INDUSTRY
Collaborators: name: Universitätsklinikum Hamburg-Eppendorf
First posted: 2013-08-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Change from Baseline in Scaling
timeFrame: at Day 7
Secondary outcomes:
measure: Psoriasis Scalp Severity Index (PSSI)
timeFrame: at Day 0, day 3, day 7, day 14
Other outcomes:
measure: Psoriasis Area Severity Index (PASI)
timeFrame: at Day 0, day 3, day 7, day 14
measure: Body Surface Area (BSA)
timeFrame: at Day 0, day 3, day 7, day 14
measure: Physician Global Assessment (PGA)
timeFrame: at Day 0, day 3, day 7, day 14
measure: Scalp Physician Global Assessment (sPGA)
timeFrame: at Day 0, day 3, day 7, day 14
measure: Dermatology Life Quality Index (DLQI)
timeFrame: at Day 0, day 3, day 7, day 14
measure: Patient Benefit Index (PBI)
timeFrame: at Day 0, day 3, day 7, day 14
measure: EuroQol Questionnaire (EQ-5D)
timeFrame: at Day 0, day 3, day 7, day 14
measure: Adverse and serious adverse events
timeFrame: 14 days
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf (UKE)
Study officials:
affiliation: University Medical Center Hamburg-Eppendorf (UKE)
name: Matthias Augustin, Prof.
role: PRINCIPAL_INVESTIGATOR
References: