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Safety and Efficacy Study of A Novel Ointment to Treat Plaque Type Psoriasis

This study has been completed.
Sponsor:
Information provided by:
Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00755196
First received: September 17, 2008
Last updated: February 9, 2011
Last verified: February 2011
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and efficacy of AN2728 Ointment, 5%, compared to Ointment Vehicle, applied twice daily for 12 weeks, in the treatment of plaque type psoriasis


Condition Intervention Phase
Psoriasis
 Drug: AN2728
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, 12 Week, Bilateral Study of the Safety and Efficacy of AN2728 Ointment, 5%, Versus Ointment Vehicle in the Treatment of Patients With Plaque Type Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

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

Primary Outcome Measures:
  • Overall Target Plaque Severity Assessment (OTPSS) at Day 84 (end of treatment) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Target Plaque Severity Assessment (OTPSS) at Days 7, 14, 28, 42, 56, 70 and 91. [ Time Frame: Days 7, 14, 28, 42, 56, 70 and 91 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
AN2728 Ointment, 5%
 Drug: AN2728
AN2728 Ointment, 5%, twice daily for 12 weeks
Other Name: AN2728 Ointment, 5%
Placebo Comparator: 2
AN2728 Ointment Vehicle
 Drug: AN2728
AN2728 Ointment Vehicle, twice daily for 12 weeks
Other Name: AN2728 Ointment Vehicle

Detailed Description:

This is a single center, randomized, double-blind, vehicle-controlled, bilateral design. Patients will apply both test articles, AN2728 Ointment, 5%, and Ointment Vehicle twice daily for 12 weeks. The assigned study medication will be applied to two comparable treatment targeted plaques identified at baseline. One test article will be applied to one plaque and the other test article to an anatomically distinct plaque. All efficacy evaluations will be measured from only the two plaques identified at the baseline visit.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female >18 years of age at time of enrollment
  2. The clinical diagnosis of stable plaque psoriasis

  3. Two target plaques of similar severity

    • ≥ 5 cm2 but ≤ 100 cm2 computed by multiplying the greatest diameter of the plaque by the diameter of the plaque perpendicular to the greatest diameter
    • Bilaterally located (right/left) plaques on the arms or distinct plaques located on the trunk. Plaques located on the trunk must be separated by at least 10 cm and will be designated by the Investigator as either left/right or front/back or upper/lower
    • Overall target plaque severity score (OTPSS) of 2-4 (mild to moderate) with no more than a 1 point difference in the scores of the individual plaques
  4. Normal or not clinically significant screening laboratory results
  5. Willing and able to apply study drug as directed, comply with study instructions and commit to all follow-up visits
  6. Ability to understand, agree to and sign the study Informed Consent Form (ICF) prior to initiation of any protocol related procedures

Exclusion Criteria:

  1. Any dermatological conditions that could interfere with clinical evaluations or any disease state or physical condition which might expose the patient to an unacceptable risk by study participation
  2. Any underlying disease(s) or other dermatological conditions that require the use of exclusionary topical or systemic therapy (see below).
  3. Known sensitivity to any of the components of the study medication
  4. Spontaneously improving or rapidly deteriorating psoriatic plaques or pustular/exfoliative, guttate, erythrodermic or other non-plaque form of psoriasis
  5. Concomitant use of topical or systemic therapies that might alter the course of psoriasis
  6. Females of child bearing potential. Females must be post-menopausal or surgically sterile (oophorectomy).

  7. Washout periods of:

    • Topical drugs that might alter the course of psoriasis: 2 weeks
    • Oral retinoids: 8 weeks
    • Non-retinoid systemic drugs that might alter the course of psoriasis: 4 weeks
    • PUVA: 4 weeks
    • UVB therapy: 4 weeks
    • Use of emollients/moisturizers on area(s) to be treated: 2 days to baseline visit
  8. AIDS or AIDS related illness
  9. Concurrent participation in another drug research study or within 30 days of enrollment
  10. Use of lithium or hydroxychloroquine containing products (i.e. Plaquenil)
  11. Use of a beta-blocking medication (i.e. propranolol) if the dose has not been stabilized for at least 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00755196

Locations
Mexico
IMIC
Mexico City, Distrito Federal, Mexico, 06700
Sponsors and Collaborators
Anacor Pharmaceuticals, Inc.
Investigators
Study Director: Lee Zane, MD, MAS Anacor Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Lee Zane, MD, MAS, Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00755196     History of Changes
Other Study ID Numbers: AN2728-PSR-202
Study First Received: September 17, 2008
Last Updated: February 9, 2011
Health Authority: United States: Food and Drug Administration
Mexico: Ministry of Health

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

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013