Scalp Psoriasis
Conditions
Keywords
Psoriasis capitis, Scaling, Salicylic acid, Dimethicone, Plaque removal
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).
Interventions
DRUGDimethicone
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.
DRUGSalicylic 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.
Sponsors
Universitätsklinikum Hamburg-Eppendorf
G. Pohl-Boskamp GmbH & Co. KG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Physician Global Assessment (PGA) | at Day 0, day 3, day 7, day 14 | To evaluate global severity of skin of patients exposed to Loion or standard therapy for psoriasis capitis |
| Scalp Physician Global Assessment (sPGA) | at Day 0, day 3, day 7, day 14 | To evaluate global severity of scalp skin of patients exposed to Loion or standard therapy for psoriasis capitis |
| Dermatology Life Quality Index (DLQI) | at Day 0, day 3, day 7, day 14 | To evaluate disease related quality of life of patients exposed to Loion or standard therapy for psoriasis capitis |
| Psoriasis Area Severity Index (PASI) | at Day 0, day 3, day 7, day 14 | To evaluate clinical outcome of patients exposed to Loion or standard therapy for psoriasis capitis |
| EuroQol Questionnaire (EQ-5D) | at Day 0, day 3, day 7, day 14 | To evaluate general state of health of patients exposed to Loion or standard therapy for psoriasis capitis |
| Adverse and serious adverse events | 14 days | Risk for adverse events and serious adverse events for patients exposed to Loion or standard therapy for psoriasis capitis |
| Patient Benefit Index (PBI) | at Day 0, day 3, day 7, day 14 | To evaluate the patient benefit of Loion or standard therapy for psoriasis capitis |
| Body Surface Area (BSA) | at Day 0, day 3, day 7, day 14 | To evaluate clinical outcome of patients exposed to Loion or standard therapy for psoriasis capitis |
Countries
Germany
Outcome results
None listed