Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00759161
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00759161
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 23, 2008
First Posted Date  ICMJE September 25, 2008
Results First Submitted Date  ICMJE January 12, 2017
Results First Posted Date  ICMJE March 6, 2017
Last Update Posted Date March 6, 2017
Study Start Date  ICMJE November 2007
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2017)
Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 28 [ Time Frame: Day 28 ]
OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity rating 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 28 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'.
Original Primary Outcome Measures  ICMJE
 (submitted: September 23, 2008)
Overall Target Plaque Severity Assessment (OTPSS) at Day 28 [ Time Frame: Day 28 ]
Change History Complete list of historical versions of study NCT00759161 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2017)
  • Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35 [ Time Frame: Baseline (Day 1), Day 7,14, 21, 28, 35 ]
    OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque.
  • Change From Baseline in Erythema at Day 7,14, 21, 28 and 35 [ Time Frame: Baseline (Day 1), Day 7,14, 21, 28, 35 ]
    Erythema is used to assess plaque severity. Investigator rated the clinical appearance of erythema on a severity scale, ranging from 0 (no color on plaque, no erythema) to 8 (extreme red color on plaque, severe erythema), where higher score indicated more severe condition.
  • Change From Baseline in Scaling at Day 7,14, 21, 28 and 35 [ Time Frame: Baseline (Day 1), Day 7,14, 21, 28, 35 ]
    Scaling is a scale to assess plaque severity. Investigator rated the clinical appearance of scaling on a severity scale, ranging from 0 (no scaling on plaque) to 8 (very thick scales on plaque), where higher score indicated more severe condition.
  • Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35 [ Time Frame: Baseline (Day 1), Day 7,14, 21, 28, 35 ]
    Plaque elevation is a scale to assess plaque severity. Investigator rated presence of plaque elevation on a severity scale ranging, from 0 (no plaque elevation) to 8 (very marked plaque elevation), where higher score indicated more severe condition.
  • Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21 and 35 [ Time Frame: Day 7,14, 21, 35 ]
    OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity rating 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, 21 and 35 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'.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2008)
  • Change of Overall Target Plaque Severity Score and erythema, scaling and plaque elevation assessments from baseline [ Time Frame: Days 7, 14, 21, 28 and 35 ]
  • Overall Target Plaque Severity Assessment (OTPSS) at Days 7, 14, 21 and 35 [ Time Frame: Days 7, 14, 21 and 35 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of A Novel Ointment to Treat Plaque Type Psoriasis
Official Title  ICMJE A Double-Blind, Randomized Bilateral Study of the Safety and Efficacy of AN2728 Ointment, 5%, Versus Ointment Vehicle in the Treatment of Patients With Plaque Type Psoriasis
Brief Summary The purpose of the study is to determine the safety and efficacy of AN2728 Ointment, 5%, compared to Ointment Vehicle in the treatment of plaque type psoriasis.
Detailed Description This is a multi-center, randomized, double-blind bilateral design. Patients will apply the test articles, AN2728 Ointment, 5%, and Ointment Vehicle twice daily. 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: AN2728
    AN2728 Ointment, 5%, twice daily for 4 weeks
    Other Name: AN2728 Ointment, 5%
  • Drug: AN2728 Ointment Vehicle
    AN2728 Ointment Vehicle, twice daily for 4 weeks.
Study Arms  ICMJE
  • Active Comparator: 1
    AN2728 Ointment, 5%
    Intervention: Drug: AN2728
  • Placebo Comparator: 2
    AN2728 Ointment Vehicle
    Intervention: Drug: AN2728 Ointment Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 23, 2008)
35
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

    1. ≥ 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.
    2. Bilaterally located (right/left) plaques on the arms or plaques located on the upper and lower trunk. Plaques located on the trunk were to be separated by at least 10 cm and designated by the Investigator as either left/right or front/back.
    3. Target plaque severity score of 2-4 (mild to moderate).
  4. Normal or not clinically significant screening laboratory results.
  5. Subjects who were willing and able to apply study drug as directed, comply with study instructions, and commit to all follow-up visits.
  6. Subjects who had the 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 (based on FSH levels) or surgically sterile (oophorectomy)
  7. Washout periods of:

    1. Topical drugs that might alter the course of psoriasis: 2 weeks
    2. Oral retinoids: 8 weeks
    3. Non-retinoid systemic drugs that might alter the course of psoriasis: 4 weeks
    4. PUVA: 4 weeks
    5. UVB therapy: 4 weeks
    6. Use of emollients/moisturizers on area(s) to be treated: 2 days prior 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00759161
Other Study ID Numbers  ICMJE AN2728-PSR-201
C3291014 ( Other Identifier: Pfizer )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2017

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