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| Name | Class |
|---|---|
| Universitätsklinikum Hamburg-Eppendorf | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loion | Experimental |
| |
| SA-Gel | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dimethicone | Drug | 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Augustin, Prof. | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf (UKE) | Hamburg | 20246 | Germany |
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| Salicylic Acid | Drug | 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. |
|
| 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 |
| ID | Term |
|---|---|
| C501844 | dimethicone |
| D020156 | Salicylic Acid |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
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