Phase 1
N=15
A 12 Day Study To Evaluate A Topical Drug To Treat Plaque Psoriasis
Psoriasis Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT02193815 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcome: Primary: Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12 — 358.9; 353.1; 17.7; 32.9 micrometers — p=0.3465
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PF06263276 (Drug); Vehicle (Other); 2%Tofacitinib Ointment (Drug); Daivonex (Drug); Daivonex Ointment (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12 |
358.9; 353.1; 17.7; 32.9 | 0.3465 |
| SECONDARY Change From Baseline in Psoriatic Skin Thickness/EPB for PF-06263276 4% Solution in Comparison to Daivonex Solution at Day 12 |
17.7; -135.5 | <0.0001 sig |
| SECONDARY Change From Baseline in Psoriatic Skin Thickness/EPB for Tofacitinib 2% Ointment in Comparison to Corresponding Vehicle at Day 12 |
364.1; 357.3; -117.8; 0.1 | <0.0001 sig |
| SECONDARY Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8 |
358.9; 353.1; 364.1; 357.3; 376.1; 364.1 | 0.3349 |
| SECONDARY Area Under the Curve (AUC) of Psoriatic Skin Thickness/EPB |
4082.60; 4161.40; 3271.93; 4013.07; 3322.40; 3165.47 | 0.7529 |
| SECONDARY Global Clinical Assessment at Day 1, 8 and 12 |
0; 0; 0; 0; 0; 0 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02193815). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.