This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00755196
First received: September 17, 2008
Last updated: January 12, 2017
Last verified: January 2017
September 17, 2008
January 12, 2017
September 2008
December 2008   (Final data collection date for primary outcome measure)
Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) at Day 84 [ Time Frame: Day 84 ]
OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 84 were reported and comparison of ointment and vehicle treated plaque was given as 'Ointment treated plaque versus (vs.) vehicle treated plaque' and 'Vehicle treated plaque vs. ointment treated plaque'.
Overall Target Plaque Severity Assessment (OTPSS) at Day 84 (end of treatment) [ Time Frame: Day 84 ]
Complete list of historical versions of study NCT00755196 on ClinicalTrials.gov Archive Site
Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91 [ Time Frame: Day 7, 14, 28, 42, 56, 70, 91 ]
OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 7, 14, 28, 42, 56, 70 and 91 were reported and comparison of ointment and vehicle treated plaque was given as 'Ointment treated plaque vs. vehicle treated plaque' and 'Vehicle treated plaque vs. ointment treated plaque'.
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 ]
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psoriasis
  • Drug: AN2728
    AN2728 Ointment, 5%, twice daily for 12 weeks
    Other Name: AN2728 Ointment, 5%
  • Drug: Ointment vehicle
    Ointment vehicle, twice daily for 12 weeks
  • Active Comparator: 1
    AN2728 Ointment, 5%
    Intervention: Drug: AN2728
  • Placebo Comparator: 2
    AN2728 Ointment vehicle
    Intervention: Drug: Ointment vehicle
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
 
NCT00755196
AN2728-PSR-202
C3291015 ( Other Identifier: Pfizer )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2017

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