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CP-690-550 Ointment For Chronic Plaque 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: NCT01246583
Recruitment Status : Completed
First Posted : November 23, 2010
Results First Posted : January 11, 2021
Last Update Posted : January 11, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The study is being conducted to see whether CP-690,550 ointment has potential as a safe and effective treatment for adult patients with mild to moderate chronic plaque psoriasis.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: CP-690,550 Ointment 1 Drug: Vehicle 1 Drug: CP-690,550 Ointment 2 Drug: Vehicle 2 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A PHASE 2A, MULTI-SITE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF THE PILOT EFFICACY, SAFETY, AND PHARMACOKINETICS OF 2 OINTMENT FORMULATIONS OF CP-690,550 IN SUBJECTS WITH MILD TO MODERATE CHRONIC PLAQUE PSORIASIS
Actual Study Start Date : February 16, 2011
Actual Primary Completion Date : November 29, 2011
Actual Study Completion Date : November 29, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Treatment Group A Drug: CP-690,550 Ointment 1
2% CP-690,550 Ointment 1 twice daily for 4 weeks

Placebo Comparator: Treatment Group B Drug: Vehicle 1
Vehicle 1 twice daily for 4 weeks

Experimental: Treatment Group C Drug: CP-690,550 Ointment 2
2% CP-690,550 Ointment 2 twice daily for 4 weeks

Placebo Comparator: Treatment Group D Drug: Vehicle 2
Vehicle 2 twice daily for 4 weeks




Primary Outcome Measures :
  1. Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 [ Time Frame: Baseline, Week 4 ]
    Target plaque was evaluated individually for signs of induration, scaling and erythema. Each of the 3 signs was rated on 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The individual signs severity sub scores were summed to calculate TPSS. The total score varied in increments of 1 and ranged from 1 to 12, with higher scores representing greater severity of psoriasis.


Secondary Outcome Measures :
  1. Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Weeks 1, 2 and 3 [ Time Frame: Baseline, Weeks 1, 2, 3 ]
    Target plaque was evaluated individually for signs of induration, scaling and erythema. Each of the 3 signs was rated on 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The individual signs severity sub scores were summed to calculate TPSS. The total score varied in increments of 1 and ranged from 1 to 12, with higher scores representing greater severity of psoriasis.

  2. Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 [ Time Frame: Baseline, Weeks 1, 2, 3, 4 ]
    Target plaque severity was evaluated individually for signs of induration, scaling and erythema. Each of the 3 signs was rated on 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked.

  3. Percentage of Participants With Treatment Area Overall Severity of Psoriasis Response of "Clear" (0) or "Almost Clear" (1) [ Time Frame: Week 1, 2, 3, 4 ]
    Treatment area overall severity of psoriasis is global consideration of the erythema, induration and scaling across all psoriatic lesions, rated separately over the treatment area according to a 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the treatment area overall severity of psoriasis score and category. Total possible score range: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.

  4. Percentage of Participants Achieving Decrease From Baseline of Greater Than or Equal to 2 Points in Treatment Area Overall Severity of Psoriasis Score [ Time Frame: Week 1, 2, 3, 4 ]
    Treatment area overall severity of psoriasis is global consideration of the erythema, induration and scaling across all psoriatic lesions, rated separately over the treatment area according to a 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the treatment area overall severity of psoriasis score and category. Total possible score: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.

  5. Percent Change From Baseline in Target Plaque Area at Week 1, 2, 3 and 4 [ Time Frame: Baseline, Week 1, 2, 3, 4 ]
    A tracing of the target plaque on transparent film was used to quantify the target plaque area. The target plaque area was calculated by image analysis (planimetry). At baseline, target plaque area was determined prior to randomization to confirm the target plaque size of at least 9 cm^2.

  6. Itch Severity Item (ISI) [ Time Frame: Baseline, Week 1, 2, 3, 4 ]
    The severity of itch was assessed using a single-item Patient Reported Outcome (PRO). Participants were asked to assess their worst itching due to psoriasis at the treatment area over the past 24 hours on a numeric rating scale ranging from of 0-10 where, 0=no itching and 10=worst possible itching.

  7. Change From Baseline in the Treatment Area Itch Severity Item (ISI) at Week 1, 2, 3 and 4 [ Time Frame: Baseline, Week 1, 2, 3, 4 ]
    The severity of itch was assessed using a single-item PRO. Participants were asked to assess their worst itching due to psoriasis at the treatment area over the past 24 hours on a numeric rating scale ranging from of 0-10 where, 0=no itching and 10=worst possible itching.

  8. Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category [ Time Frame: Week 4 ]
    The PSSM evaluates overall participants satisfaction with the study treatment. Participants response evaluation was based on single 7-point item: 1=very satisfied, 2=somewhat satisfied, 3=slightly satisfied, 4=neither satisfied nor dissatisfied, 5=slightly dissatisfied, 6=somewhat dissatisfied, and 7=very dissatisfied.

  9. Number of Participants With Administration Site Adverse Events [ Time Frame: Baseline up to follow up visit (Day 36-39 after last dose of study treatment) (up to maximum of 9.5 weeks) ]
    An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug. Application site adverse event included documentation of any clinically significant local reaction, e.g erosion, vesicles or scabbing.

  10. Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area [ Time Frame: Baseline, Week 1, 2, 3, 4 ]
    Burning/stinging symptoms at the treatment area including target plaque, additional plaque/s within the treatment area (if any) and treated perilesional skin (if any) were queried from the participants and scored by the investigator using a 4-point scale: 0=none; 1=Mild; 2=Moderate; 3=Severe. Except at baseline pre-dosing, burning/stinging was assessed for 2 time periods based on the maximum burning or stinging that the participant has experienced: Immediate (within 5 minutes after application); Persistent (beyond 5 minutes after application).

  11. Number of Participants With Draize Score of Perilesional Skin in The Treatment Area [ Time Frame: Baseline, Week 1, 2, 3, 4 ]
    Draize scoring evaluated perilesional skin within treatment area for erythema and presence/absence of other signs and symptoms. Erythema score ranged from 0 to 4 as: 0(no reaction visible), 1(trace reactions- barely perceptible pinkness), 2(mild reaction- readily visible pinkness), 3(moderate reaction- definite redness), 4 (Strong to severe reaction- very intense redness). Letter grade defined as: J(Burning, stinging, itching), E(Edema), P(Papules), V(Vesicles), B(Bulla reaction), S(Spreading), W(Weeping), I(Induration), XC(Additional comments). Superficial observations defined as: G(Glazing), Y(Peeling), C(Scab), D(Hyperpigmentation), H(Hypopigmentation), F(Fissuring), R(Erosion), U(Ulceration), K(Scaling). Erythema and other signs/symptoms with at least 1 participant with Draize Score of Perilesional Skin in the treatment area were reported in this outcome measure.

  12. Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 [ Time Frame: Baseline, Week 1, 2, 3, 4 ]
    Blood pressure (BP) was measured in duplicate (approximately 5 minutes apart) using a standard calibrated BP measuring device. BP defined as pressure exerted by circulating blood upon walls of blood vessels. Diastolic BP is minimum pressure in arteries, near beginning of cardiac cycle when ventricles are filled with blood. Systolic BP is peak pressure in arteries, near end of the cardiac cycle when ventricles are contracting. Normal blood pressure is less than 120 millimeters of mercury (mmHg) systolic and less than 80 mmHg diastolic. Change=value at week 1, 2, 3, 4 minus value at baseline.

  13. Change From Baseline in Heart Rate at Week 1, 2, 3, 4 [ Time Frame: Baseline, Week 1, 2, 3, 4 ]
    Heart (pulse) rate was measured in duplicate (approximately 5 minutes apart) for a minimum of 30 seconds. Heart rate is the number of heartbeats per unit of time, usually per minute. The heart rate is based on the number of contractions of the ventricles (the lower chambers of the heart). Change=value at week 1, 2, 3, 4 minus value at baseline.

  14. Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 [ Time Frame: Baseline, Week 4 ]
    A single standard supine 12-lead Electrocardiogram (ECG) was performed after the participant had rested quietly for at least 10 minutes. ECG parameters included RR interval, PR interval, QRS complex, QT interval, QTcB (corrected for heart rate using Bazett's formula) interval, and QTcF (corrected for heart rate using Fridericia's formula) interval.

  15. Change From Baseline in Hemoglobin Level at Week 2, 4 [ Time Frame: Baseline, Week 2, 4 ]
  16. Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 [ Time Frame: Baseline, Week 2, 4 ]
  17. Change From Baseline in Creatinine Level at Week 2, 4 [ Time Frame: Baseline, Week 2, 4 ]
  18. Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 [ Time Frame: Baseline, Week 2, 4 ]
  19. Plasma Concentration of CP-690,550 [ Time Frame: 0 (predose), 1, 2 and 4-9 hours postdose on Day 29 or early termination ]
    Summary statistics were calculated by setting concentration values below the lower limit of quantification (lower limit of quantification=0.1 nanogram per milliliter [ng/mL]) to zero. Summary statistics were not presented if number of observations above lower limit of quantification (NALQ) = 0.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild to moderate chronic plaque psoriasis (psoriasis vulgaris), with the duration of at least 6 months;
  • A target plaque of at least 9 sq. cm.

Exclusion Criteria:

  • Demonstrates "rebound" or "flare" of chronic plaque psoriasis;
  • Non plaque form of psoriasis;
  • Currently have or history of psoriatic arthritis;
  • Current drug induced psoriasis;
  • Currently on systemic therapy or was on systemic therapy for psoriasis within the previous 6 months;
  • Currently on phototherapy for psoriasis or was on phototherapy within the previous 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01246583


Locations
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United States, Alabama
Horizon Research Group, Inc.
Mobile, Alabama, United States, 36608
United States, California
Dermatology Research Associates
Los Angeles, California, United States, 90045
Expresscare Medical
Los Angeles, California, United States, 90045
United States, Florida
Park Avenue Dermatology, PA
Orange Park, Florida, United States, 32073
United States, Nebraska
Skin Specialists, PC
Omaha, Nebraska, United States, 68144
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
United States, South Dakota
Health Concepts
Rapid City, South Dakota, United States, 57702
United States, Texas
Modern Research Associates, PLLC
Dallas, Texas, United States, 75231
Canada, Ontario
K.Papp Clinical Research Inc.
Waterloo, Ontario, Canada, N2J 1C4
Canada, Quebec
Innovaderm Research Inc
Montreal, Quebec, Canada, H2K 4L5
Siena Medical Research
Montreal, Quebec, Canada, H3Z 2S6
Canada
Centre de Recherche Dermatologique du Quebec metropolitain
Quebec, Canada, G1V 4X7
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01246583    
Other Study ID Numbers: A3921116
First Posted: November 23, 2010    Key Record Dates
Results First Posted: January 11, 2021
Last Update Posted: January 11, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Keywords provided by Pfizer:
Multi Site
Randomized
Placebo Controlled
Double Blind
Parallel Group
chronic plaque psoriasis
topical treatment
skin diseases
papulosquamous
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action