A Study to Determine the Efficacy and Safety of 122-0551 in Subjects With Plaque Psoriasis

NCT ID: NCT01700985

Last Updated: 2018-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-03-31

Brief Summary

Corticosteroids are one of the mainstays of treatment for subjects with corticosteroid-responsive dermatoses such as psoriasis. This study has been designed to determine and compare the efficacy and safety of a formulation of 122-0551 versus the corresponding Vehicle in subjects with stable plaque psoriasis after twice daily dosing for 14 consecutive days.

Conditions

Psoriasis; Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

122-0551

Group Type: EXPERIMENTAL

122-0551

Intervention Type: DRUG

Applied twice daily for two weeks

Vehicle

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

Applied twice daily for two weeks

Interventions

122-0551

Applied twice daily for two weeks

Intervention Type: DRUG

Vehicle

Applied twice daily for two weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subject has a clinical diagnosis of stable plaque psoriasis
• Subject has an ODS score for the Treatment Area of 3 or 4 at study start

Exclusion Criteria

• Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
• Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.
• Subject has used any phototherapy, photo-chemotherapy or systemic corticosteroid therapy within 30 days prior to study start
• Subject has used any systemic methotrexate, retinoids, cyclosporine or analogous products within 90 days prior to study start
• Subject has used any systemic biologic therapy for the treatment of psoriasis within 5 half-lives of the biologic prior to study start
• Subject had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to study start
• Subject has used topical body (excluding the scalp) psoriasis therapy including coal tar, anthralin, steroids, retinoids, vitamin D analogs (e.g., Dovonex®) within 14 days prior to study start
• Subject has used emollients/moisturizers on areas to be treated within four hours prior to clinical evaluation at study start
• Subject is currently using lithium or Plaquenil (hydroxychloroquine)
• Subject is currently using a beta-blocking medication (e.g., propranolol) or ACE (e.g., lisinopril) inhibitor at a dose that has not been stabilized
• Subject is pregnant, lactating, or is planning to become pregnant during the study
• Subject is currently enrolled in an investigational drug or device study
• Subject has used an investigational drug or investigational device treatment within 30 days prior to study start
• Subject has been previously enrolled in this study and treated with a test article

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Syd Dromgoole, PhD

Role: STUDY_DIRECTOR

Therapeutics, Inc.

Locations

Therapeutics Clinical Research

San Diego, California, United States

DermResearch, Inc.

Austin, Texas, United States

Countries

United States

Other Identifiers

122-0551-203

Identifier Type: -

Identifier Source: org_study_id