A Comparison of DFD01 Spray Versus Vehicle Spray in Subjects With Moderate Psoriasis

The objectives of this study are to compare the efficacy and safety of DFD01 Spray to Vehicle Spray for topical treatment of moderate plaque psoriasis

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: DFD01 Spray; Drug: Vehicle Spray

• Study Type: Interventional
• Enrollment (Actual): 277
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Coastal Clinical Research, Inc.
  • Arizona
    • Tempe, Arizona, United States, 85282
      • Hudson Dermatology/Clinical Research Advantage
  • California
    • Oceanside, California, United States, 92056
      • Dermatology Specialists, Inc.
    • San Diego, California, United States, 92123
      • University Clinical Trials, Inc
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
  • Colorado
    • Denver, Colorado, United States, 80220
      • Horizons Clinical Research Center, LLC
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Skin Care Research, Inc.
    • Brandon, Florida, United States, 33511
      • MOORE Clinical Research, Inc.
    • Miami, Florida, United States, 33175
      • FXM Research Corop.
    • North Miami Beach, Florida, United States, 33162
      • Dr. Tory P. Sullivan, MD, PA
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Augusta Centre for Dermatology and Skin Renewal, LLC
    • Snellville, Georgia, United States, 30078
      • Gwinnett Clinical Research Center, Inc.
  • Kentucky
    • Corbin, Kentucky, United States, 40701
      • MLFKnuckles, MD, PSC
  • Louisiana
    • Lake Charles, Louisiana, United States, 70605
      • Shondra L. Smith, MD Dermatology & Advanced Aesthetics
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Medical Center, New Center One
    • Fort Gratiot, Michigan, United States, 48059
      • Hamzavi Dermatology
    • Warren, Michigan, United States, 48088
      • Grekin Skin Institute
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists P.C.
  • Nevada
    • Henderson, Nevada, United States, 89074
      • Bettencourt Skin Center
  • New York
    • Rochester, New York, United States, 14623
      • Skin Search of Rochester, Inc.
  • Ohio
    • Cincinnati, Ohio, United States, 45249
      • Radiant Research, Inc.
    • Warren, Ohio, United States, 44483
      • Brodell Medical, Inc.
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Testing Company, Inc.
  • Texas
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies, Ltd, LLP
    • San Antonio, Texas, United States, 78229
      • Dermatology Clinical Research Center of San Antonio
    • San Antonio, Texas, United States, 78229
      • Progressive Clinical Reesearch, PA
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research Center, LLC
  • Washington
    • Walla Walla, Washington, United States, 99362
      • Eastern Washington Dermatology

Participation Criteria

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.

Use within 180 days prior to Baseline Visit of biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, or alefacept).

Have received treatment for any type of cancer within 5 years of the Baseline Visit except skin cancer and cervical cancer (in situ) are allowed within 1 year of the Baseline Visit.

Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea) or 3) oral retinoids (e.g., acitretin, isotretinoin).

Use within 30 days prior to the Baseline Visit of: 1) systemic steroids, 2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy. Inhaled, intraocular, and intranasal steroids are allowed.

Use within 14 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriene), 2) topical retinoids (e.g., tazarotene, tretinoin) or 3) topical corticosteroids.

Require use of beta blockers, lithium, ACE inhibitors, and/or NSAIDs (indomethacin, ibuprofen, aspirin, naproxen) with a medical history that these medications affect the subject's psoriasis, except if the subject has been using the medication routinely during the 180 days prior to the Baseline Visit, these medications are allowed.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DFD01 Spray; DFD01 Spray twice daily	Drug: DFD01 Spray
Placebo Comparator: Vehicle Spray; Vehicle Spray twice daily	Drug: Vehicle Spray

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Primus Pharmaceuticals
• Collaborators: Prosoft Clinical

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: October 17, 2013
• First Submitted That Met QC Criteria: October 17, 2013
• First Posted (Estimated): October 22, 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: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 1206