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

Psoriasis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01967069
• Other study ID #: 1206
• Status: Completed
• Phase: Phase 3
• Start date: November 2013
• Est. completion date: July 2014

Study information

• Verified date: March 2024
• Source: Primus Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• DFD01 Spray

• Vehicle Spray

Locations

Country	Name	City	State
United States	Augusta Centre for Dermatology and Skin Renewal, LLC	Augusta	Georgia
United States	Skin Care Research, Inc.	Boca Raton	Florida
United States	MOORE Clinical Research, Inc.	Brandon	Florida
United States	Charlottesville Medical Research Center, LLC	Charlottesville	Virginia
United States	Radiant Research, Inc.	Cincinnati	Ohio
United States	MLFKnuckles, MD, PSC	Corbin	Kentucky
United States	Horizons Clinical Research Center, LLC	Denver	Colorado
United States	Henry Ford Medical Center, New Center One	Detroit	Michigan
United States	Hamzavi Dermatology	Fort Gratiot	Michigan
United States	Bettencourt Skin Center	Henderson	Nevada
United States	Center for Clinical Studies, LTD, LLP	Houston	Texas
United States	Shondra L. Smith, MD Dermatology & Advanced Aesthetics	Lake Charles	Louisiana
United States	FXM Research Corop.	Miami	Florida
United States	Coastal Clinical Research, Inc.	Mobile	Alabama
United States	Dr. Tory P. Sullivan, MD, PA	North Miami Beach	Florida
United States	Dermatology Specialists, Inc.	Oceanside	California
United States	Skin Specialists P.C.	Omaha	Nebraska
United States	Paddington Testing Company, Inc.	Philadelphia	Pennsylvania
United States	Skin Search of Rochester, Inc.	Rochester	New York
United States	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas
United States	Progressive Clinical Reesearch, PA	San Antonio	Texas
United States	University Clinical Trials, Inc	San Diego	California
United States	Clinical Science Institute	Santa Monica	California
United States	Gwinnett Clinical Research Center, Inc.	Snellville	Georgia
United States	Hudson Dermatology/Clinical Research Advantage	Tempe	Arizona
United States	Eastern Washington Dermatology	Walla Walla	Washington
United States	Brodell Medical, Inc.	Warren	Ohio
United States	Grekin Skin Institute	Warren	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Primus Pharmaceuticals	Prosoft Clinical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Treatment Success According to the Investigator's Global Assessment (IGA)	IGA of clear or almost clear	Day 15