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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
394

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Primus Pharmaceuticals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 20, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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