A Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis
| Status: | Completed |
|---|---|
| Conditions: | Psoriasis |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 3/28/2019 |
| Start Date: | May 2007 |
| End Date: | April 2009 |
A Double-Blind, Vehicle-Controlled, Rising Dose, Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis
The study is comprised of two parts. The first portion of this study will be a double-blind,
Sponsor-unblinded, vehicle-controlled study with application of ruxolitinib or vehicle to
paired lesions at least 15 cm apart in patients with active but stable plaque psoriasis. Part
2 of the study is a double-blind, sponsor unblinded, comparison of ruxolitinib with two FDA
approved products in patients with active but stable plaque psoriasis.
Sponsor-unblinded, vehicle-controlled study with application of ruxolitinib or vehicle to
paired lesions at least 15 cm apart in patients with active but stable plaque psoriasis. Part
2 of the study is a double-blind, sponsor unblinded, comparison of ruxolitinib with two FDA
approved products in patients with active but stable plaque psoriasis.
Inclusion Criteria:
- Body Mass Index (BMI) of 17 to 40 kg/m2
- Subjects must have two comparable psoriatic lesions measuring between 9 and 100 cm2
and these target lesions must be similar in size to each other, and separated by at
least 15 cm.
Exclusion Criteria:
- Subjects with lesions solely involving the palms of the hands or soles of the feet or
intertriginous areas, the scalp or the face.
- Subjects with pustular psoriasis or erythroderma.
- Subjects currently on other topical agents or UVB therapy within 2 weeks of the first
dose of study medication.
- Subjects receiving PUVA within 4 weeks of the first dose of study medication.
- Subjects receiving systemic retinoids, etanercept, adalimumab or efalizumab or oral
immunosuppressives within 3 months prior to the first dose of study medication.
- Subjects receiving any other biological therapy (infliximab, alefacept, abatacept,
etc) within 3 months of the first dose of study medication.
We found this trial at
6
sites
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