A Comparison of DFD01 Spray Versus Comp01 Lotion, Vehicle Spray and Vehicle Lotion in Subjects With Moderate Psoriasis

March 5, 2024 updated by: Primus Pharmaceuticals
The objectives of this study are to compare the safety of DFD01 Spray to Comp01 Lotion for topical treatment of moderate plaque psoriasis and to compare the efficacy of DFD01 Spray to Placebo Spray for topical treatment of moderate plaque psoriasis after 28 days of treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

394

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Horizon Research Group, Inc.
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Burke Pharmaceutical Research
    • California
      • Encinitas, California, United States, 92024
        • California Dermatology and Clinical Research Institute
      • Encino, California, United States, 91436
        • Encino Research Center
      • Fremont, California, United States, 94538
        • Center for Dematology Clinical Research, Inc.
      • San Diego, California, United States, 92117
        • Skin Surgery Medical Group, Inc.
      • Santa Rosa, California, United States, 95403
        • Redwood Dermatology Research
    • Colorado
      • Denver, Colorado, United States, 80209
        • Cherry Creek Research, Inc.
      • Denver, Colorado, United States, 80210
        • Colorado Medical Research Center Inc.
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • The Savin Center, PC
    • Florida
      • Miami, Florida, United States, 33136
        • Florida Academic Center Research and Education
      • Miami, Florida, United States, 33144
        • International Dermatology Research Inc.
    • Indiana
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center
      • South Bend, Indiana, United States, 46617
        • South Bend Clinic, LLP
    • Kansas
      • Olathe, Kansas, United States, 66061
        • Compliant Clinical Research Inc.
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Dermatology Specialists Research
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Lawrence J. Green, MD, LLC
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • David Fivenson, MD, PLC
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Quality Clinical Research, Inc.
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
        • Psoriasis Treatment Center of Central NJ
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Academic Dermatology Associates
    • New York
      • New York, New York, United States, 10155
        • Fran Cook-Bolden, MD
      • Stony Brook, New York, United States, 11790
        • DermResearch Center of New York Stony Brook Medical Park
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Zoe Diane Draelos, MD, PA
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
      • Winston-Salem, North Carolina, United States, 27101
        • PMG Research of Winston-Salem
    • Ohio
      • South Euclid, Ohio, United States, 44118
        • Haber Dermatology & Cosmetic Surgery, Inc.
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Carolina Dermatology of Greenville, PA
      • Mount Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072
        • Rivergate Dermatology Clinical Research Center, PLLC
      • Nashville, Tennessee, United States, 37215
        • Tennessee Clinical Research Center
    • Texas
      • Austin, Texas, United States, 78759
        • Dermresearch, Inc.
      • College Station, Texas, United States, 77845
        • J & S Studies, Inc.
      • Houston, Texas, United States, 77056
        • The Center for Skin Research
      • San Antonio, Texas, United States, 78249
        • Stephen Miller, MD, PA
      • Webster, Texas, United States, 77598
        • Center for Clinical Studies
    • Utah
      • Salt Lake City, Utah, United States, 84117
        • Dermatology Research Center, Inc.
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • The Education & Research Foundation, Inc.
      • Norfolk, Virginia, United States, 23507
        • Virginia Clinical Research, Inc.
    • Washington
      • Spokane, Washington, United States, 99204
        • Premier Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.
  • Subjects with psoriasis involving 10 to 20% BSA, not including the face, scalp, groin, axillae and other intertriginous areas.
  • Subjects must have an IGA grade of 3 (moderate) at the Baseline Visit

Exclusion Criteria:

  • Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
  • Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).
  • Presence of pigmentation, extensive scarring, or pigmented lesions or sunburn which could interfere with the rating of efficacy parameters.
  • History of psoriasis unresponsive to topical treatments.
  • History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DFD01 Spray
DFD01 Spray twice daily for 28 days
Drug: DFD01 Spray
Other Names:
  • Topical corticosteroid spray
Placebo Comparator: Vehicle Spray
Vehicle Spray twice daily for 28 days
Drug: Vehicle Spray
Active Comparator: Comp01 Lotion
Comp01 Lotion twice daily for 14 days
Drug: Comp01 Lotion
Other Names:
  • Topical corticosteroid lotion
Placebo Comparator: Vehicle Lotion
Vehicle Lotion twice daily for 28 days
Drug: Vehicle Lotion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Success According to the Investigator Global Assessment (IGA)
Time Frame: Day 15
IGA of clear or almost clear
Day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Primus Pharmaceuticals

Collaborators

Prosoft Clinical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

September 17, 2013

First Submitted That Met QC Criteria

September 17, 2013

First Posted (Estimated)

September 20, 2013

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1205

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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