A Phase I Study to Assess Novel Cream in a Psoriasis Plaque Test
Summary
The purpose of this study is to investigate dose-response relationship, antipsoriatic efficacy and safety of different concentrations of topical formulations with AN2728 in subjects with psoriasis vulgaris.
Description
The study will be performed in 12 male subjects with stable psoriatic plaques. The study preparations and the comparator will be tested observer-blind. Treatments will be randomly assigned to the test fields. All subjects will receive all treatments, with intraindividual comparison of the treatments.
Altogether six test fields will be examined per subject (four active AN2728 creams of different concentrations: 2 %, 1 %, 0.3 %, 0.03 %, the active ingredient-free vehicle, and a marketed corticoid preparation). The test fields will be treated occlusively over a study period of 12 days. Topical application of approximately 200 uL of each assigned intervention is administered per treatment, for a total of 10 treatments over a 12-day treatment period.
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Psoriasis
Intervention
AN2728 Cream, 2%, AN2728 Cream, 1%, AN2728 Cream, 0.3%, AN2728 Cream Vehicle, Betnesol®-V Creme, 0.1%
Location
Bioskin GmbH
Hamburg
Germany
10117
Status
Completed
Source
Anacor Pharmaceuticals, Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00763204
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Ice Cream
A frozen dairy food made from cream or butterfat, milk, sugar, and flavorings. Frozen custard and French-type ice creams also contain eggs.
Dienestrol
A synthetic, non-steroidal estrogen structurally related to stilbestrol. It is used, usually as the cream, in the treatment of menopausal and postmenopausal symptoms.
Flurandrenolone
A corticosteroid used topically in the treatment of various skin disorders. It is usually employed as a cream or an ointment, and is also used as a polyethylene tape with an adhesive. (From Martindale, The Extra Pharmacopoeia, 30th ed, p733)
Drimys
A plant genus of the family WINTERACEAE. They have leathery, elliptic-shaped leaves; red-tinged shoots; and jasmine-scented, cream-colored, 8- to 12-petaled, 2.5-centimeter (1-inch) flowers in clusters.
Butter
The fatty portion of milk, separated as a soft yellowish solid when milk or cream is churned. It is processed for cooking and table use. (Random House Unabridged Dictionary, 2d ed)
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