Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

MOL4239

+ Placebo

Drug
Who is being recruted

Skin Diseases+1

+ Skin and Connective Tissue Diseases

+ Skin Diseases, Papulosquamous

From 18 to 72 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorMoleculin, LLC
Last updated: December 24, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01826201
Principal SponsorMoleculin, LLC
Last updated: December 24, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

21 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 72 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Skin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, PapulosquamousPsoriasis

Criteria

11 inclusion criteria required to participate
Adults, males or females, 18 to 72 years of age (both inclusive.)
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
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
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
Show More Criteria
10 exclusion criteria prevent from participating
Any significant uncontrolled medical disease
Current diagnosis of unstable forms of psoriasis in the treatment area, including guttate, erythrodermic, exfoliative or pustular psoriasis
Females who are pregnant, breast feeding, or planning a pregnancy
Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

International Dermatology Research, Inc.

Miami, United StatesOpen International Dermatology Research, Inc. in Google Maps

Minnesota Clinical Study Center

Fridley, United States

Academic Dermatology Associates

Albuquerque, United States
Completed3 Study Centers