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A Comparison of DFD01 Spray Versus Vehicle Spray in Subjects With Moderate Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT01967069•Primus Pharmaceuticals

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (28)

Coastal Clinical Research, Inc.

Mobile, Alabama, United States

Hudson Dermatology/Clinical Research Advantage

Tempe, Arizona, United States

Dermatology Specialists, Inc.

Oceanside, California, United States

University Clinical Trials, Inc

San Diego, California, United States

Clinical Science Institute

Santa Monica, California, United States

Horizons Clinical Research Center, LLC

Denver, Colorado, United States

Skin Care Research, Inc.

Boca Raton, Florida, United States

MOORE Clinical Research, Inc.

Brandon, Florida, United States

FXM Research Corop.

Miami, Florida, United States

Dr. Tory P. Sullivan, MD, PA

North Miami Beach, Florida, United States

Key Dates

Start Date

November 1, 2013

Primary Completion Date

July 1, 2014

Completion Date

July 1, 2014

Last Updated

March 7, 2024

Enrollment

277

ACTUAL participants

Conditions

Psoriasis

Interventions

DFD01 Spray

DRUG

Vehicle Spray

DRUG

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Psoriasis

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NCT07116967

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments