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

NCT01967069 | Completed Phase 3 Results

• 1 other identifier: 1206
• Study Type: interventional
• Target: 277
• Locations: 1 country
• Sites: 28

Brief Summary

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

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Treatment Success According to the Investigator's Global Assessment (IGA)

  IGA of clear or almost clear

  Day 15

Study Arms (2)

DFD01 Spray

ACTIVE COMPARATOR

DFD01 Spray twice daily

Drug: DFD01 Spray

Vehicle Spray

PLACEBO COMPARATOR

Vehicle Spray twice daily

Drug: Vehicle Spray

Interventions

DFD01 Spray DRUG

DFD01 Spray

Vehicle Spray DRUG

Vehicle Spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Primus Pharmaceuticals: lead
• Prosoft Clinical: collaborator

Study Sites (28)

Coastal Clinical Research, Inc.

Mobile, Alabama, 36608, United States

Location

Hudson Dermatology/Clinical Research Advantage

Tempe, Arizona, 85282, United States

Location

Dermatology Specialists, Inc.

Oceanside, California, 92056, United States

Location

University Clinical Trials, Inc

San Diego, California, 92123, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Horizons Clinical Research Center, LLC

Denver, Colorado, 80220, United States

Location

Skin Care Research, Inc.

Boca Raton, Florida, 33486, United States

Location

MOORE Clinical Research, Inc.

Brandon, Florida, 33511, United States

Location

FXM Research Corop.

Miami, Florida, 33175, United States

Location

Dr. Tory P. Sullivan, MD, PA

North Miami Beach, Florida, 33162, United States

Location

Augusta Centre for Dermatology and Skin Renewal, LLC

Augusta, Georgia, 30909, United States

Location

Gwinnett Clinical Research Center, Inc.

Snellville, Georgia, 30078, United States

Location

MLFKnuckles, MD, PSC

Corbin, Kentucky, 40701, United States

Location

Shondra L. Smith, MD Dermatology & Advanced Aesthetics

Lake Charles, Louisiana, 70605, United States

Location

Henry Ford Medical Center, New Center One

Detroit, Michigan, 48202, United States

Location

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059, United States

Location

Grekin Skin Institute

Warren, Michigan, 48088, United States

Location

Skin Specialists P.C.

Omaha, Nebraska, 68144, United States

Location

Bettencourt Skin Center

Henderson, Nevada, 89074, United States

Location

Skin Search of Rochester, Inc.

Rochester, New York, 14623, United States

Location

Radiant Research, Inc.

Cincinnati, Ohio, 45249, United States

Location

Brodell Medical, Inc.

Warren, Ohio, 44483, United States

Location

Paddington Testing Company, Inc.

Philadelphia, Pennsylvania, 19103, United States

Location

Center for Clinical Studies, LTD, LLP

Houston, Texas, 77004, United States

Location

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States

Location

Progressive Clinical Reesearch, PA

San Antonio, Texas, 78229, United States

Location

Charlottesville Medical Research Center, LLC

Charlottesville, Virginia, 22911, United States

Location

Eastern Washington Dermatology

Walla Walla, Washington, 99362, United States

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Promius Pharma

kgulbronson@promiuspharma.com

609-282-1476

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: October 22, 2013
• Study Start: November 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 7, 2024
• Results First Posted: March 13, 2017

Record last verified: 2024-03

Locations

US (28)