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Topical CP-690,550 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: NCT00678561
Recruitment Status : Completed
First Posted : May 15, 2008
Results First Posted : December 31, 2020
Last Update Posted : December 31, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
Study will test effectiveness of an experimental drug applied once or twice daily to two psoriasis plaques. Requires 1 clinic visit each week for 5 weeks.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: PHASE 2A RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, INTRA-INDIVIDUAL COMPARISON TRIAL ASSESSING SAFETY, TOLERATION, PHARMACOKINETICS AND PILOT EFFICACY OF 4 WEEKS TREATMENT WITH TOPICAL CP-690,550 IN CHRONIC PLAQUE PSORIASIS
Actual Study Start Date : October 13, 2008
Actual Primary Completion Date : July 9, 2009
Actual Study Completion Date : July 24, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: 2% CP-690,550 QD Drug: CP-690,550
Topical treatment once daily for 28 days

Experimental: 0.2% CP-690,550 QD Drug: CP-690,550
Topical treatment once daily for 28 days

Experimental: 0.02% CP-690,550 QD Drug: CP-690,550
Topical treatment once daily for 28 days

Experimental: 2% CP-690,550 BID Drug: CP-690,550
Topical treatment twice daily for 28 days

Experimental: 0.2% CP-690,550 BID Drug: CP-690,550
Topical treatment twice daily for 28 days

Experimental: 0.02% CP-690,550 BID Drug: CP-690,550
Topical treatment twice daily for 28 days

Placebo Comparator: Placebo Vehicle QD Drug: Placebo Vehicle
Topical treatment once daily for 28 days

Placebo Comparator: Placebo Vehicle BID Drug: Placebo Vehicle
Topical treatment twice daily for 28 days




Primary Outcome Measures :
  1. Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 [ Time Frame: Baseline, Week 4 ]
    TPSS: all target lesions were scored individually by the investigator for signs of induration, scaling, and erythema. For large target lesions only a portion of the lesion was treated and only the treated portion was rated. Each of the 3 signs was rated on a 5-point severity scale: 0 = none; 1 = slight; 2 = moderate; 3 = marked; 4 = very marked. Total score range for TPSS was 0 to 12, higher score indicated greater severity of disease.


Secondary Outcome Measures :
  1. Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions [ Time Frame: Week 4 ]
    PGA of Psoriasis: The investigator scored each target lesion on a 5-point scale, reflecting the erythema, induration and scaling separately for each target lesions. Each parameter was scored from 0 to 4, with appropriate morphologic descriptors. The 5-point scale for PGA was: 0, "clear"; 1, "almost clear"; 2, "mild"; 3, "moderate"; 4 "severe". The sum of the 3 scores was divided by 3 to obtain a final PGA score. Total score range: 0 to 4, higher score indicated greater severity of disease. Success was considered as PGA response of "clear" and "almost clear".

  2. Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 [ Time Frame: Baseline, Week 1, 2, 3 ]
    TPSS: all target lesions were scored individually by the investigator for signs of induration, scaling, and erythema. For large target lesions only a portion of the lesion was treated and only the treated portion was rated. Each of the 3 signs was rated on a 5-point scale: 0 = none; 1 = slight; 2 = moderate; 3 = marked; 4 = very marked. Total score range for TPSS was 0 to 12, higher score indicated greater severity of disease.

  3. Number of Participants With Administration Site Adverse Events [ Time Frame: Baseline up to 7 to 10 days after last dose of study treatment (maximum up to 38 days) ]
    An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug. Administration site adverse event included documentation of any clinically significant local reaction, such as erosion, vesicles or scabbing.

  4. Drug Plasma Concentrations of CP-690,555 [ Time Frame: 0 hour (pre-dose) on Day 14 and 0 hour (pre-dose), 1, 2, 9 hours post-dose on Day 28 ]
    Concentrations below the limit of quantification (LOQ) were not estimable. The LOQ was 0.1 ng/mL.

  5. Skin Biopsy Drug Concentrations [ Time Frame: Day 28 ]
    Skin biopsy drug concentrations was measured via drug levels in dermis and expressed as nanogram of drug per milligram (mg) of dermis weight. Tissue concentration (ng/mg) = (ng drug/mL extraction solvent multiplied by mL extraction solvent) divided by mg tissue weight; 1 mL of extraction solvent was used.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having chronic plaque psoriasis for at least 6 months
  • Able to withdraw all prior psoriasis treatments
  • Must agree to avoid prolonged exposure to the sun and avoid use of tanning booths or other ultraviolet light sources during the study

Exclusion Criteria:

  • Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis
  • Pregnant or lactating women
  • Unwilling to use appropriate contraceptive methods

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): NCT00678561


Locations
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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: NCT00678561    
Other Study ID Numbers: A3921038
First Posted: May 15, 2008    Key Record Dates
Results First Posted: December 31, 2020
Last Update Posted: December 31, 2020
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:
chronic plaque psoriasis
topical treatment
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