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A Safety and Efficacy Study of DRM02 in Subjects With Plaque 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: NCT01993433
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : April 15, 2014
Sponsor:
Information provided by (Responsible Party):
Dermira, Inc.

Brief Summary:
The purpose of this study is to determine whether DRM02 is safe and effective in the treatment of plaque psoriasis when applied twice daily for 6 weeks.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: DRM02 Other: Vehicle Phase 2

Detailed Description:

This is a double-blind, randomized, within-subject control, study enrolling 20 subjects with plaque psoriasis and designed to assess the safety, tolerability, and preliminary efficacy of DRM02.

Safety will be assessed during the study, through adverse events, local skin responses, urinalysis, serum chemistry and hematology laboratory testing, physical examination and vital signs.

Preliminary efficacy will be assessed through the Physician's Lesion Assessment (PLA) and the Severity of Psoriasis Area Severity Index (PASI) from only the two plaques identified at the baseline visit.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Vehicle Controlled Study of the Safety and Efficacy of Topical DRM02 in Subjects With Plaque Psoriasis
Study Start Date : October 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: DRM02
DRM02 Topical Gel, 0.25%
Drug: DRM02
Placebo Comparator: Vehicle
DRM02 Topical Gel, Vehicle
Other: Vehicle



Primary Outcome Measures :
  1. Change in Physician's Lesion Assessment [ Time Frame: Week 6 ]

Secondary Outcome Measures :
  1. Physician's Lesion Assessment [ Time Frame: From baseline to weeks 0, 1, 2, 3, 4 and 6 ]
  2. PLA dichotomized into "success" and "failure" [ Time Frame: Week 6 ]

Other Outcome Measures:
  1. Severity of Target Lesion PASI scores [ Time Frame: Week 6 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female 18 to 70 years of age.
  • Plaque-type psoriasis with two lesions of similar size and have an identical score of at least 6 but no more than 8 on the sum of the individual components of the Severity of Psoriasis Area Severity Index (PASI) at the Target Lesion scale.
  • Male or non-pregnant, non-lactating females.
  • Signed informed consent.

Exclusion Criteria:

  • Subjects who have extensive, and/or 'inverse', and/or exfoliative psoriasis.
  • Subjects who have taken any systemic treatment for psoriasis within the 4 weeks prior to baseline.
  • Prior or concomitant use of topical treatments for psoriasis to within 10 cm of the target lesion within the 4 weeks prior to baseline.
  • Use of Enbrel within the 4 weeks prior to baseline.
  • Psoralen & ultraviolet A therapy (PUVA) or the use of ultraviolet B (UVB) therapy and/or excessive or prolonged exposure to ultraviolet light within the 4 weeks prior to baseline.
  • Use of Humira or Remicade within the 3 months prior to baseline.
  • Use of Stelara within the 6 months prior to baseline.
  • Subjects who have taken oral retinoids for psoriasis within the 6 months prior to baseline.
  • Subjects who have poor skin condition within 5 cm of the target lesion.
  • Subjects who are current drug or alcohol abusers; have a history of immunodeficiency disease or are a poor medical risk because of other systemic diseases or active uncontrolled infections.
  • Subjects with an unstable medical condition or a medical condition not adequately controlled with standard medical therapy.
  • Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days
  • Subjects who have a clinically significant laboratory value at screening.

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): NCT01993433


Locations
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Canada, Quebec
Clinique Médicale Dr Isabelle Delorme
Drummondville, Quebec, Canada, J2B5L4
Innovaderm Research, Inc
Montreal, Quebec, Canada, H2K 4L5
Sponsors and Collaborators
Dermira, Inc.
Investigators
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Study Director: Beth Zib Dermira, Inc.
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Responsible Party: Dermira, Inc.
ClinicalTrials.gov Identifier: NCT01993433    
Other Study ID Numbers: DRM02-PSO02
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: April 15, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases