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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Stable Plaque Psoriasis
• Intervention / Treatment: Drug: Vehicle Cream; Drug: DFD06-Cream

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 265
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Site 101
    • Mobile, Alabama, United States, 36608
      • Site 103
  • Arizona
    • Mesa, Arizona, United States, 85202
      • Site 130
    • Phoenix, Arizona, United States, 85251
      • Site 116
    • Tucson, Arizona, United States, 85712
      • Site 125
  • California
    • North Hollywood, California, United States, 91606
      • Site 120
    • San Diego, California, United States, 92117
      • Site 114
    • Santa Monica, California, United States, 90404
      • Site 127
  • Florida
    • Clearwater, Florida, United States, 33756
      • Site 128
    • Miami, Florida, United States, 33144
      • Site 115
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Site 118
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Site 110
  • Maryland
    • Glenn Dale, Maryland, United States, 20769
      • Site 105
  • Michigan
    • Warren, Michigan, United States, 48088
      • Site 111
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Site 113
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Site 123
  • New Hampshire
    • Newington, New Hampshire, United States, 03801
      • Site 106
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Site 104
  • New York
    • Stony Brook, New York, United States, 11790
      • Site 117
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Site 124
    • Winston-Salem, North Carolina, United States, 27157
      • Site 109
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Site 129
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Site 119
    • Greenville, South Carolina, United States, 29607
      • Site 102
  • Texas
    • Austin, Texas, United States, 78759
      • Site 108
    • Houston, Texas, United States, 77030
      • Site 122
    • Plano, Texas, United States, 75024
      • Site 107
  • Utah
    • Draper, Utah, United States, 84020
      • Site 112
  • Washington
    • Spokane, Washington, United States, 99202
      • Site 126
    • Walla Walla, Washington, United States, 99362
      • Site 121

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle Cream; Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.	Drug: Vehicle Cream; Twice daily topical application for 14 days.
Experimental: DFD-06 cream; DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.	Drug: DFD06-Cream; Twice daily topical application for 14 days.; Other Names: Clobetasol propionate Cream, 0.025%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Promius Pharma, LLC
• Investigators: Study Director: Srinivas Sidgiddi, MD, Dr Reddy's Laboratories Inc

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: May 13, 2015
• First Submitted That Met QC Criteria: May 14, 2015
• First Posted (Estimate): May 15, 2015

Study Record Updates

• Last Update Posted (Actual): May 15, 2018
• Last Update Submitted That Met QC Criteria: April 13, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Clobetasol
• Other Study ID Numbers: DFD06-CD-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No