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A Comparison of DFD01 Spray Versus Comp01 Lotion, Vehicle Spray and Vehicle Lotion in Subjects With Moderate Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
DFD01 Spray
Comp01 Lotion
Vehicle Lotion
Vehicle Spray
Sponsored by
Encore Dermatology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Horizon Research Group, Inc.
  • Burke Pharmaceutical Research
  • California Dermatology and Clinical Research Institute
  • Encino Research Center
  • Center for Dematology Clinical Research, Inc.
  • Skin Surgery Medical Group, Inc.
  • Redwood Dermatology Research
  • Cherry Creek Research, Inc.
  • Colorado Medical Research Center Inc.
  • The Savin Center, PC
  • Florida Academic Center Research and Education
  • International Dermatology Research Inc.
  • The Indiana Clinical Trials Center
  • South Bend Clinic, LLP
  • Compliant Clinical Research Inc.
  • Dermatology Specialists Research
  • Lawrence J. Green, MD, LLC
  • David Fivenson, MD, PLC
  • Quality Clinical Research, Inc.
  • Psoriasis Treatment Center of Central NJ
  • Academic Dermatology Associates
  • Fran Cook-Bolden, MD
  • DermResearch Center of New York Stony Brook Medical Park
  • Zoe Diane Draelos, MD, PA
  • Wake Research Associates, LLC
  • PMG Research of Winston-Salem
  • Haber Dermatology & Cosmetic Surgery, Inc.
  • Carolina Dermatology of Greenville, PA
  • Coastal Carolina Research Center
  • Rivergate Dermatology Clinical Research Center, PLLC
  • Tennessee Clinical Research Center
  • DermResearch, Inc.
  • J & S Studies, Inc.
  • The Center for Skin Research
  • Stephen Miller, MD, PA
  • Center for Clinical Studies
  • Dermatology Research Center, Inc.
  • The Education & Research Foundation, Inc.
  • Virginia Clinical Research, Inc.
  • Premier Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

DFD01 Spray

Vehicle Spray

Comp01 Lotion

Vehicle Lotion

Arm Description

DFD01 Spray twice daily for 28 days

Vehicle Spray twice daily for 28 days

Comp01 Lotion twice daily for 14 days

Vehicle Lotion twice daily for 28 days

Outcomes

Primary Outcome Measures

Percentage of Participants With Success According to the Investigator Global Assessment (IGA)
IGA of clear or almost clear

Secondary Outcome Measures

Full Information

First Posted
September 17, 2013
Last Updated
September 10, 2020
Sponsor
Encore Dermatology, Inc.
Collaborators
Prosoft Clinical
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1. Study Identification

Unique Protocol Identification Number
NCT01947491
Brief Title
A Comparison of DFD01 Spray Versus Comp01 Lotion, Vehicle Spray and Vehicle Lotion in Subjects With Moderate Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Encore Dermatology, Inc.
Collaborators
Prosoft Clinical

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objectives of this study are to compare the safety of DFD01 Spray to Comp01 Lotion for topical treatment of moderate plaque psoriasis and to compare the efficacy of DFD01 Spray to Placebo Spray for topical treatment of moderate plaque psoriasis after 28 days of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
394 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DFD01 Spray
Arm Type
Experimental
Arm Description
DFD01 Spray twice daily for 28 days
Arm Title
Vehicle Spray
Arm Type
Placebo Comparator
Arm Description
Vehicle Spray twice daily for 28 days
Arm Title
Comp01 Lotion
Arm Type
Active Comparator
Arm Description
Comp01 Lotion twice daily for 14 days
Arm Title
Vehicle Lotion
Arm Type
Placebo Comparator
Arm Description
Vehicle Lotion twice daily for 28 days
Intervention Type
Drug
Intervention Name(s)
DFD01 Spray
Other Intervention Name(s)
Topical corticosteroid spray
Intervention Type
Drug
Intervention Name(s)
Comp01 Lotion
Other Intervention Name(s)
Topical corticosteroid lotion
Intervention Type
Drug
Intervention Name(s)
Vehicle Lotion
Intervention Type
Drug
Intervention Name(s)
Vehicle Spray
Primary Outcome Measure Information:
Title
Percentage of Participants With Success According to the Investigator Global Assessment (IGA)
Description
IGA of clear or almost clear
Time Frame
Day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Horizon Research Group, Inc.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Burke Pharmaceutical Research
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
California Dermatology and Clinical Research Institute
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Encino Research Center
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Center for Dematology Clinical Research, Inc.
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Skin Surgery Medical Group, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92117
Country
United States
Facility Name
Redwood Dermatology Research
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Cherry Creek Research, Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Colorado Medical Research Center Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
The Savin Center, PC
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Florida Academic Center Research and Education
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
International Dermatology Research Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
The Indiana Clinical Trials Center
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
South Bend Clinic, LLP
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Compliant Clinical Research Inc.
City
Olathe
State/Province
Kansas
ZIP/Postal Code
66061
Country
United States
Facility Name
Dermatology Specialists Research
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Lawrence J. Green, MD, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
David Fivenson, MD, PLC
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Facility Name
Quality Clinical Research, Inc.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Psoriasis Treatment Center of Central NJ
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Fran Cook-Bolden, MD
City
New York
State/Province
New York
ZIP/Postal Code
10155
Country
United States
Facility Name
DermResearch Center of New York Stony Brook Medical Park
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Zoe Diane Draelos, MD, PA
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
PMG Research of Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
Facility Name
Haber Dermatology & Cosmetic Surgery, Inc.
City
South Euclid
State/Province
Ohio
ZIP/Postal Code
44118
Country
United States
Facility Name
Carolina Dermatology of Greenville, PA
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Rivergate Dermatology Clinical Research Center, PLLC
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
J & S Studies, Inc.
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
The Center for Skin Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Stephen Miller, MD, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Center for Clinical Studies
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Dermatology Research Center, Inc.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
The Education & Research Foundation, Inc.
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29657667
Citation
Sidgiddi S, Pakunlu RI, Allenby K. Efficacy, Safety, and Potency of Betamethasone Dipropionate Spray 0.05%: A Treatment for Adults with Mild-to-moderate Plaque Psoriasis. J Clin Aesthet Dermatol. 2018 Apr;11(4):14-22. Epub 2018 Apr 1.
Results Reference
derived

Learn more about this trial

A Comparison of DFD01 Spray Versus Comp01 Lotion, Vehicle Spray and Vehicle Lotion in Subjects With Moderate Psoriasis

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