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

NCT02635204 | Completed Phase 3 Results

• 1 other identifier: DFD06-CD-004
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 30

Brief 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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Treatment Success at Day 15

  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. Primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.

  Day 15 Visit

Secondary Outcomes (2)

• Percent Change From Baseline in Body Surface Area at Day 15

  Baseline and Day 15

• Percent of Subjects With Treatment Success at Day 8 Visit

  Baseline and Day 8

Study Arms (2)

DFD-06 Cream

EXPERIMENTAL

DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.

Drug: DFD06 Cream

Vehicle Cream

PLACEBO COMPARATOR

Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.

Drug: Vehicle Cream

Interventions

DFD06 Cream DRUG

Twice daily topical application for 14 days.

Also known as: Clobetasol propionate Cream, 0.025%

DFD-06 Cream

Vehicle Cream DRUG

Twice daily topical application for 14 days.

Vehicle Cream

Eligibility Criteria

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

You may qualify if:

• 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.
• Subject must be at least 18 years of age.
• Subject must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.
• Subject with psoriasis involving 3% or greater BSA, not including the face, scalp, groin, axillae and other intertriginous areas.
• Subject must have an IGA grade of 3 or 4 (moderate to severe) at the Baseline Visit.
• 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.
• 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).

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 biological or 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, secukinumab, 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 if at least 1 year before the Baseline Visit.
• 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).
• 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.
• Subjects who have participated in a study of an investigational drug 60 days prior to the Baseline Visit.

Sponsors & Collaborators

• Promius Pharma, LLC: lead

Study Sites (30)

Site 116

Glendale, Arizona, 85308, United States

Location

Site 111

Rogers, Arkansas, 72758, United States

Location

Site 124

Fountain Valley, California, 92708, United States

Location

Site 120

Laguna Hills, California, 92653, United States

Location

Site 122

San Diego, California, 92108, United States

Location

Site 123

San Diego, California, 92123, United States

Location

Site 113

Denver, Colorado, 80220, United States

Location

Site 117

New Haven, Connecticut, 06511, United States

Location

Site 108

Brandon, Florida, 33511, United States

Location

Site 112

Coral Gables, Florida, 33134, United States

Location

Site 106

Jacksonville, Florida, 32204, United States

Location

Site 110

Pinellas Park, Florida, 33781, United States

Location

130

West Palm Beach, Florida, 33406, United States

Location

Site 103

Arlington Heights, Illinois, 60005, United States

Location

Site 115

Overland Park, Kansas, 66215, United States

Location

Site 127

Beverly, Massachusetts, 01915, United States

Location

Site 119

Quincy, Massachusetts, 02169, United States

Location

129

Henderson, Nevada, 89052, United States

Location

Site 114

New York, New York, 10019, United States

Location

Site 104

Rocky Mount, North Carolina, 27804, United States

Location

Site 105

Wilmington, North Carolina, 28401, United States

Location

Site 126

Cincinnati, Ohio, 45255, United States

Location

Site 121

Warwick, Rhode Island, 02886, United States

Location

Site 107

Nashville, Tennessee, 37215, United States

Location

128

Arlington, Texas, 76014, United States

Location

Site 101

Dallas, Texas, 75234, United States

Location

Site 102

Houston, Texas, 77056, United States

Location

Site 109

San Antonio, Texas, 78229, United States

Location

Site 118

Norfolk, Virginia, 23507, United States

Location

Site 125

Richmond, Virginia, 23294, 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: Srinivas Sidgiddi, MD
• Organization: Dr. Reddy's Lab, Inc

srinivassidgiddi@drreddys.com

609-375-9900

Study Officials

• Srinivas Sidgiddi, MD

  Dr. Reddy's Laboratories, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: December 18, 2015
• Study Start: December 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 15, 2018
• Results First Posted: April 13, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (30)