A Phase I Study to Assess Novel Ointment in a Psoriasis Plaque Test

This study has been completed.
Sponsor:
Information provided by:
Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00762658
First received: September 26, 2008
Last updated: October 22, 2008
Last verified: October 2008
  Purpose

To investigate dose-response relationship, antipsoriatic efficacy and safety of different concentrations of topical formulations of AN2728 in patients with psoriasis vulgaris


Condition Intervention Phase
Psoriasis
Drug: 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 %
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Anacor Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Efficacy of the active study preparations compared to the corresponding vehicle using differences in infiltrate thickness on study day 12. [ Time Frame: Day 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in infiltrate thickness [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
  • Sonographic measurements of infiltrate thickness [ Time Frame: Day 8, Day 12 ] [ Designated as safety issue: No ]
  • The AUC of the infiltrate thickness [ Time Frame: Day 8, Day 12 ] [ Designated as safety issue: No ]
  • Clinical assessment scores for assessment of efficacy [ Time Frame: Day 8, Day 12 ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: November 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AN2728 Ointment, 5%
Drug: AN2728 Ointment, 5%
Experimental: 2
AN2728 Ointment, 2%
Drug: AN2728 Ointment, 2%
Experimental: 3
AN2728 Ointment, 0.5%
Drug: AN2728 Ointment, 0.5%
Placebo Comparator: 4
AN2728 Ointment Vehicle
Drug: AN2728 Ointment Vehicle
Active Comparator: 5
Betnesol®-V Creme (betamethasone 0.1 %)
Drug: Betnesol®-V Creme, 0.1%
Other Name: betamethasone 0.1%
Active Comparator: 6
Protopic® Ointment (tacrolimus 0.1 %)
Drug: Protopic® Ointment, 0.1 %
Other Name: tacrolimus 0.1 %

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00762658

Locations
Germany
Bioskin GmbH
Hamburg, Germany, 10117
Sponsors and Collaborators
Anacor Pharmaceuticals, Inc.
Investigators
Study Director: Karl Beutner, MD, PhD Anacor Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Karl Beutner, MD, PhD, Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00762658     History of Changes
Other Study ID Numbers: AN2728-PSR-102
Study First Received: September 26, 2008
Last Updated: October 22, 2008
Health Authority: United States: Institutional Review Board
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Anacor Pharmaceuticals, Inc.:
Plaque Type Psoriasis
Topical

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone sodium phosphate
Tacrolimus
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 23, 2014