Psoriasis Vulgaris Clinical Trial
Official title:
A Phase 1, Single- Center, Randomized, Double-blind, Vehicle And Active Comparator-controlled Trial To Evaluate The Antipsoriatic Activity And Safety Of A Topically Applied Pf-06263276 Formulation In A Psoriasis Plaque Test
Verified date | March 2015 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This is a vehicle and comparator controlled Proof of Mechanism (PoM) trial to evaluate the effect on psoriasis disease activity and safety of topically applied PF 06263276 in subjects with psoriasis vulgaris.
Status | Completed |
Enrollment | 15 |
Est. completion date | February 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Healthy male and/or female subjects age 18 years and older, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests. - Subjects with psoriasis vulgaris in a chronic stable phase and with a plaque area of mild to moderate severity sufficient for six treatment fields located in up to three plaque areas. - The target lesion(s) should be on the trunk or extremities (excluding palms/soles). Psoriatic lesions on the knees or elbows are not to be used as a target lesion. Exclusion Criteria: - Subjects with psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, psoriasis arthropathica and pustular psoriasis. - Treatment with any systemic medications which in the opinion of the investigator might counter or influence the trial aim (including anti psoriasis medications, eg, corticosteroids, cytostatics or retinoids) or medications which are known to provoke or aggravate psoriasis (eg, beta blocker, anti malarial drugs, lithium) or phototherapy/psoralen+UVA (PUVA) within 4 weeks preceding the treatment phase of the trial and during the trial. - Treatment with any locally acting medications (including anti-psoriasis medications like vitamin D analogues, dithranol) within 4 weeks of the treatment phase. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Bioskin GmbH | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in psoriatic skin thickness using 4% solution of PF-06263276 in comparison to vehicle. | Assessed using 20 MHz sonographic measurement | 11 days of treatment | No |
Secondary | Change from baseline in psoriatic skin thickness using 4% solution of PF-06263276 in comparison to Daivonex solution (50 ug/ml). | Assessed using 20 MHz sonographic measurement | 11 days of treatment | No |
Secondary | Change from baseline in psoriatic skin thickness using 2% ointment of Tofacitinib in comparison to vehicle. | Assessed using 20 MHz sonographic measurement | 11 days of treatment | No |
Secondary | Change from baseline in psoriatic skin thickness | Assessed using 20 MHz sonographic measurement | 7 days of treatment | No |
Secondary | Area Under the Curve from Time Zero to end of dosing interval (AUCtau) | Assessed using 20 MHz sonographic measurement | 11 days of treatment | No |
Secondary | Global Clinical Assessment | Visual examination using a 5 point score | Study Days 1, 8 and 12 | No |
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