A Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis

Chronic Stable Plaque Psoriasis Clinical Trial

Official title:

A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Parallel Group Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis for 14 Days

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02445807
• Other study ID #: DFD06-CD-005
• Status: Completed
• Phase: Phase 3
• Start date: December 2015
• Est. completion date: July 2016

Study information

• Verified date: April 2018
• Source: Promius Pharma, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topical treatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of treatment.

Description:

This study will be a multicenter (approximately 30 sites), randomized, vehicle-controlled, double-blind, and parallel group design. Approximately 264 subjects with moderate to severe plaque psoriasis will be randomized to treatment with DFD-06 Cream or Vehicle Cream. Subjects will use study product twice daily for 14 days. Subject visits are scheduled at Screening, Baseline (Day 1) and Days 4, 8, and 15. Clinical determinations of disease severity will be performed using the total sign score (TSS) for the target lesion and Investigator Global Assessment (IGA) for overall severity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject understands the study procedures and agrees to participate by giving written informed consent. Subjects must be willing to authorize use and disclosure of protected health information collected for the study.

2. Subject must be at least 18 years of age.

3. Subject must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.

4. Subject with psoriasis involving 3% or greater BSA, not including the face, scalp, groin, axillae and other intertriginous areas.

5. Subject must have an IGA grade of 3 or 4 (moderate to severe) at the Baseline Visit.

6. Female subjects of childbearing potential must agree to use contraception during the study which can include abstinence with an adequate secondary option should the subject become sexually active. All women of childbearing potential must complete a urine pregnancy test (test must have a sensitivity of at least 25mIU/ml for human chorionic gonadotropin) at the Baseline Visit (Visit 2) and the test result must be negative to be eligible for enrollment.

7. Subject must be in good general health as determined by the investigator and supported by the medical history and normal or not clinically significant abnormal vital signs (blood pressure and pulse).

Exclusion Criteria:

1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.

2. Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).

3. Presence of pigmentation, extensive scarring, or pigmented lesions or sunburn which could interfere with the rating of efficacy parameters.

4. History of psoriasis unresponsive to biological or topical treatments.

5. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.

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

7. 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 if at least 1 year before the Baseline Visit.

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

9. 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.

10. 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.

11. Subjects who have participated in a study of an investigational drug 60 days prior to the Baseline Visit.

Related Conditions & MeSH terms

• Chronic Stable Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• DFD06-Cream
Twice daily topical application for 14 days.
• Vehicle Cream
Twice daily topical application for 14 days.

Locations

Country	Name	City	State
United States	Site 104	Albuquerque	New Mexico
United States	Site 119	Anderson	South Carolina
United States	Site 108	Austin	Texas
United States	Site 101	Birmingham	Alabama
United States	Site 128	Clearwater	Florida
United States	Site 112	Draper	Utah
United States	Site 113	Fridley	Minnesota
United States	Site 105	Glenn Dale	Maryland
United States	Site 102	Greenville	South Carolina
United States	Site 124	High Point	North Carolina
United States	Site 122	Houston	Texas
United States	Site 118	Indianapolis	Indiana
United States	Site 129	Johnston	Rhode Island
United States	Site 110	Louisville	Kentucky
United States	Site 130	Mesa	Arizona
United States	Site 115	Miami	Florida
United States	Site 103	Mobile	Alabama
United States	Site 106	Newington	New Hampshire
United States	Site 120	North Hollywood	California
United States	Site 116	Phoenix	Arizona
United States	Site 107	Plano	Texas
United States	Site 123	Saint Joseph	Missouri
United States	Site 114	San Diego	California
United States	Site 127	Santa Monica	California
United States	Site 126	Spokane	Washington
United States	Site 117	Stony Brook	New York
United States	Site 125	Tucson	Arizona
United States	Site 121	Walla Walla	Washington
United States	Site 111	Warren	Michigan
United States	Site 109	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Promius Pharma, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy (Percentage of Subjects With Treatment Success)	The primary efficacy endpoint is the percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2 grade reduction from Baseline) at the Day 15 visit.; The primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.	Day 15 Visit
Secondary	The Percent Change in Body Surface Area of Psoriasis	The percent change from baseline in Body Surface Area at Day 15. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.	From Baseline to Day 15
Secondary	The Percentage of Subjects With Treatment Success at the Day 8 Visit.	The percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2 grade reduction from Baseline) at Day 8.; The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.	At Day 8 Visit