Paired Psoriasis Lesion, Comparative, Study to Evaluate MOL4239 in Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: MOL4239; Placebo
Intervention description: 10% MOL4239 ointment to one target lesion twice a day for 28.5 consecutive days; placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 72 Years
Healthy volunteers: No
Keywords: psoriasis

Summary:

      The purpose of this study is to determine whether MOL4239 is effective in adult subjects with
      mild to moderate plaque psoriasis by comparing two target lesions in which each subject will
      apply MOL4239 ointment to one target lesion and placebo ointment to the contralateral target
      lesion twice a day for 28.5 consecutive days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults, males or females, 18 to 72 years of age (both inclusive.)

          -  Mild to moderate plaque psoriasis with lesions that in total are no more than 9.9% BSA
             and with a baseline Psoriasis Severity Score (PSS) of 6 or more.

          -  Identification of bilaterally symmetrical or approximately equivalent target lesions
             of at least 2.5 x 2.5 cm (~6 cm2) on the trunk, arms or legs to mid calf with a
             Psoriasis Severity Score (PSS) of 6 or greater.

          -  Willing to avoid tanning devices or exposure of the treated skin to the sun.

          -  Willing to not use cosmetics, including lotions, creams, and moisturizers on the
             treated lesions.

          -  Use of Eucerin® is allowed on all non-test site areas.

          -  Willing to forgo systemic and other topical treatments for psoriasis during the course
             of the study.

          -  Willing to avoid bathing or swimming for two hours after study drug treatment.

          -  Negative urine pregnancy test at Screening and baseline for women of childbearing
             potential (WOCP).

          -  Sexually active WOCP participating in the study must agree to use a medically
             acceptable method of contraception while on study.

          -  Must have recovered from the effects of any surgery, other than minor office surgical
             procedures, and a minimum of 3 months must have elapsed from the day of surgery to the
             day of screening.

        Exclusion Criteria:

          -  Presence of significant abnormalities of liver or renal functions.

          -  Presence of any clinically significant lab abnormalities at screening.

          -  Any significant uncontrolled medical disease.

          -  Use of the anti-tumor necrosis factor (TNF) biologic agents 4 months prior to
             randomization or use of Stelara 6 months prior to randomization.

          -  Use, within one month prior to baseline or during the study, of: 1) systemic
             immunosuppressive drugs (e.g., tacrolimus), or 2) oral meds (e.g. methotrexate,
             retinoids, etc.).

          -  Use within one month prior to baseline or during the study of: 1) Systemic
             corticosteroids, 2) Systemic antibiotics, 3) other systemic antipsoriatic treatment,
             4) oral psoralen with ultraviolet A (PUVA) therapy, or 5) ultraviolet B (UVB) therapy.

          -  Use within two weeks prior to baseline or during the study of: 1) topical
             anti-psoriatic drugs, 2) topical corticosteroids, 3) other topical retinoids, or 4)
             topical immunosuppressive agents.

          -  Current diagnosis of unstable forms of psoriasis in the treatment area, including
             guttate, erythrodermic, exfoliative or pustular psoriasis.

          -  Other inflammatory skin disease in the treatment area that may confound the evaluation
             of the psoriasis vulgaris.

          -  Females who are pregnant, breast feeding, or planning a pregnancy.