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Completed

NCT Number: NCT00678561

Topical CP-690,550 For Chronic Plaque Psoriasis

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Guildford Dermatology Specialists, Surrey, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CP-690,550

Drug

Topical treatment once daily for 28 days

placebo vehicle

Drug

Topical treatment once daily for 28 days

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 15, 2008
Registry last updated
Dec 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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