Clinical trial NCT01826201: Paired Psoriasis Lesion, Comparative, Study to Evaluate MOL4239 in Psoriasis
Official title: A Phase 2a, Randomized, Blinded, Paired Psoriasis Lesion, Comparative, Placebo-controlled Study to Evaluate the Safety, Preliminary Efficacy and Pharmacokinetics of Epidermal Administrations of MOL4239 in Adults With Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: psoriasis
Lead sponsor: Moleculin, LLC
Sponsor class: INDUSTRY
First posted: 2013-04-08
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean Change From Baseline to Day 28 in PSS (Psoriasis Severity Score) of the Treatment Target Lesions Compared to Placebo Target Lesions
timeFrame: Baseline and Day 28
Secondary outcomes:
measure: Improvement in Lesion Appearance
timeFrame: Baseline and Day 28
measure: Physician's Treatment Preference
timeFrame: Day 7, Day 14, Day 28
measure: Treatment Success
timeFrame: Baseline and Day 28
measure: Change in EIS Area
timeFrame: Baseline and Day 28
measure: Safety Assessment
timeFrame: Baseline and Day 28
Other outcomes:
Locations:
city: Miami
country: United States
facility: International Dermatology Research, Inc.
state: Florida
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
Study officials:
affiliation: Academic Dermatology Associates
name: Eduardo Tschen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Dermatology Research, Inc.
name: Javier Alonso-Llamazares, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Minnesota Clinical Study Center
name: Steven Kempers, MD
role: PRINCIPAL_INVESTIGATOR
References: