A Phase I Study to Assess Novel Ointment in a Psoriasis Plaque Test
Information source: Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psoriasis
Intervention: AN2728 Ointment, 5% (Drug); AN2728 Ointment, 2% (Drug); AN2728 Ointment, 0.5% (Drug); AN2728 Ointment Vehicle (Drug); Betnesol®-V Creme, 0.1% (Drug); Protopic® Ointment, 0.1 % (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Anacor Pharmaceuticals, Inc. Official(s) and/or principal investigator(s): Karl Beutner, MD, PhD, Study Director, Affiliation: Anacor Pharmaceuticals, Inc.
Summary
To investigate dose-response relationship, antipsoriatic efficacy and safety of different
concentrations of topical formulations of AN2728 in patients with psoriasis vulgaris
Clinical Details
Official title: A Phase I, Randomized, Observer-Blind, Single-Center, Vehicle- and Comparator-Controlled, Initial Dose-Ranging Study to Assess the Antipsoriatic Efficacy of Different Concentrations of AN2728 Ointment in a Psoriasis Plaque Test
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Efficacy of the active study preparations compared to the corresponding vehicle using differences in infiltrate thickness on study day 12.
Secondary outcome: Change in infiltrate thicknessSonographic measurements of infiltrate thickness The AUC of the infiltrate thickness Clinical assessment scores for assessment of efficacy
Detailed description:
The study will be performed in 12 male subjects with stable psoriatic plaques. The study
preparations and the comparators 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 (three active AN2728 ointments of
different concentrations: 5 %, 2 % and 0. 5 %, the active ingredient-free vehicle, a marketed
corticoid preparation and a marketed topical immunomodulator). The test fields will be
treated occlusively over a study period of 12 days. A topical application of approximately
200 uL of each assigned intervention will be administered per treatment, for a total of 10
treatments over a 12-day treatment period.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- male subjects aged 18 years or older;
- subjects with psoriasis vulgaris in a chronic stable phase and stable plaques with an
area sufficient for six treatment fields;
- the physical examination must be without disease findings unless the investigator
considers an abnormality to be irrelevant to the outcome of the study;
- written informed consent obtained.
Exclusion Criteria:
- subjects who require systemically acting medications for the treatment of psoriasis,
which might counter or influence the study objectives, e. g. corticosteroids,
cytostatics;
- local treatment with antipsoriatics (except for salicylic acid in vaseline) in the 4
weeks preceding and during the study (corticosteroids 8 weeks);
- systemic treatment with antipsoriatics in the three months preceding and during the
study;
- treatment with systemic or locally acting medications which might counter or
influence the study aim (e. g. glucocorticosteroids, MAO inhibitors, anti-epileptic
drugs, anti-psychotic drugs) or medications which are known to provoke or aggravate
psoriasis, e. g. β-blocker, antimalarial drugs within two weeks before the beginning
of the study and during the study;
- known allergic reactions to the active ingredients or other components of the study
preparations or comparators;
- evidence of drug abuse;
- UV-therapy within four weeks before beginning and during the study;
- symptoms of a clinically significant illness that may influence the outcome of the
study in the four weeks before and during the study;
- participation in another clinical trial involving pharmaceutical products in the four
weeks preceding and during the study;
- in the opinion of the investigator or physician performing the initial examination
the patient should not participate in the study, e. g. due to probable noncompliance
or inability to understand the study and give adequately informed consent.
- subject is institutionalized because of legal or regulatory order.
Locations and Contacts
Bioskin GmbH, Hamburg 10117, Germany
Additional Information
Starting date: November 2007
Last updated: October 22, 2008
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