Paired Psoriasis Lesion, Comparative, Study to Evaluate MOL4239 in Psoriasis
Paired Psoriasis Lesion, Comparative, Study to Evaluate MOL4239 in Psoriasis
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.
This is a phase 2a, Randomized, Multi-center, Blinded, Paired Psoriasis Lesion, Comparative
 Placebo-Controlled study to evaluate the safety, preliminary efficacy and pharmacokinetics of
 MOL4239 in 30 adult subjects with mild to moderate plaque psoriasis. Eligible subject will
 have a diagnosis of mild to moderate plaque psoriasis affecting 9.9% body surface area (BSA)
 or less, and two designated similar target lesions with a Psoriasis Severity Score of at
 least 6 or higher. Each subject will apply 10% MOL4239 ointment to one target lesion and
 placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days.
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.