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

September 17, 2008
February 9, 2011
September 2008
December 2008   (final data collection date for primary outcome measure)
Overall Target Plaque Severity Assessment (OTPSS) at Day 84 (end of treatment) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00755196 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of A Novel Ointment to Treat Plaque Type Psoriasis
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

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psoriasis
  • Drug: AN2728
    AN2728 Ointment, 5%, twice daily for 12 weeks
    Other Name: AN2728 Ointment, 5%
  • Drug: AN2728
    AN2728 Ointment Vehicle, twice daily for 12 weeks
    Other Name: AN2728 Ointment Vehicle
  • Active Comparator: 1
    AN2728 Ointment, 5%
    Intervention: Drug: AN2728
  • Placebo Comparator: 2
    AN2728 Ointment Vehicle
    Intervention: Drug: AN2728
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT00755196
AN2728-PSR-202
No
Lee Zane, MD, MAS, Anacor Pharmaceuticals, Inc.
Anacor Pharmaceuticals, Inc.
Not Provided
Study Director: Lee Zane, MD, MAS Anacor Pharmaceuticals, Inc.
Anacor Pharmaceuticals, Inc.
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP