Status:
COMPLETED
A Study to Evaluate and Compare the Efficacy and Pharmacokinetics of MK-0873 for the Treatment of Plaque Psoriasis (MK-0873-022)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Psoriasis
Plaque Psoriasis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a within-participant comparison study to investigate the efficacy of a 28-day regimen of MK-0873 2% cream twice a day (b.i.d.) compared to MK-0873 vehicle (matching placebo) b.i.d. as well as ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Is a male or female 18 to 65 years of age
- Female subjects of reproductive potential must have a negative serum pregnancy test at screening and agree to use and/or have their partner use two (2) acceptable methods of birth control
- Has a Body Mass Index (BMI) ≤36 kg/m\^2 (up to 40 kg/m\^2 may be enrolled, in consultation with Sponsor)
- Has diagnosis of plaque-type psoriasis at least 6 month prior to administration of study drug (participants with concurrent psoriatic arthritis may be enrolled)
- Has plaque-type psoriasis with at least two pairs of symmetrically located plaque lesions that exhibit similar baseline TLS values (TLS in each plaque ≥6 and
- ± 2 points difference between left and right plaque lesions)
- Has plaque-type psoriasis with lesion severity score ≥4 covering at least 1 to 20% of total body surface area at screening and at baseline.
- Is judged to be in good health based on medical history, physical examination, vital sign measurements, electrocardiogram assessment, and laboratory safety tests
- Exclusion Criteria
- Has nonplaque forms of psoriasis (e.g., Erythrodermic, guttate, or pustular).
- Has current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers or lithium).
- Has received phototherapy or any systemic medications/treatments that could affect psoriasis or TLS evaluation (including but not limited to oral or injectable corticosteroids, retinoids, 1, 25-dihydroxy vitamin D3 and analogues, psoralens, sulfsalazine, hydroxyurea, fumaric acid derivatives, or herbal treatments) within 4 weeks of study drug administration.
- Has used topical medications/treatments that could affect psoriasis or TLS evaluation (e.g., corticosteroids, coal tar, anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, methoxsalen, trimethyl psoralens) within 2 weeks of study drug administration.
- Has used any systemic immunosuppressants (e.g., Methotrexate, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, or tacrolimus) within 4 weeks of study drug administration or biologics (e.g., anti-tumor necrosis factor \[TNF\], anti-interleukins) within 3 months of study drug administration.
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01235728
Start Date
November 1 2010
End Date
April 1 2011
Last Update
February 8 2019
Active Locations (2)
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1
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Fort Myers, Florida, United States, 33901
2
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Miramar, Florida, United States, 33025