Conditions: Psoriasis
Keywords: psoriasis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 21
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: 10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days

Interventions: intervention 1: MOL4239 intervention 2: Placebo
Intervention descriptions: intervention 1: 10% MOL4239 ointment to one target lesion twice a day for 28.5 consecutive days intervention 2: placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days

Protocol document: