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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01947491
Recruitment Status : Completed
First Posted : September 20, 2013
Results First Posted : October 6, 2016
Last Update Posted : September 11, 2020
Sponsor:
Collaborator:
Prosoft Clinical
Information provided by (Responsible Party):
Encore Dermatology, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: DFD01 Spray Drug: Comp01 Lotion Drug: Vehicle Lotion Drug: Vehicle Spray Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 394 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : November 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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Arm Intervention/treatment
Experimental: DFD01 Spray
DFD01 Spray twice daily for 28 days
 Drug: DFD01 Spray
Other Name: Topical corticosteroid spray
Placebo Comparator: Vehicle Spray
Vehicle Spray twice daily for 28 days
 Drug: Vehicle Spray
Active Comparator: Comp01 Lotion
Comp01 Lotion twice daily for 14 days
 Drug: Comp01 Lotion
Other Name: Topical corticosteroid lotion
Placebo Comparator: Vehicle Lotion
Vehicle Lotion twice daily for 28 days
 Drug: Vehicle Lotion


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Success According to the Investigator Global Assessment (IGA) [ Time Frame: Day 15 ]
    IGA of clear or almost clear


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01947491


Locations
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Sponsors and Collaborators
Encore Dermatology, Inc.
Prosoft Clinical
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Encore Dermatology, Inc.
ClinicalTrials.gov Identifier: NCT01947491    
Other Study ID Numbers: 1205
First Posted: September 20, 2013    Key Record Dates
Results First Posted: October 6, 2016
Last Update Posted: September 11, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases