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A Safety and Efficacy of DRM02 in Subjects With Atopic Dermatitis

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. Identifier: NCT01993420
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : April 15, 2014
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 atopic dermatitis when applied twice daily for 6 weeks.

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

Detailed Description:

This is a double-blind, randomized, within-subject control, study enrolling 20 subjects with atopic dermatitis 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 Eczema Area and Severity Index (EASI) from only the two lesions identified at the baseline visit.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 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 Atopic Dermatitis
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: Eczema

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 analyzed for treatment effect [ Time Frame: From baseline to weeks 1, 2, 3, 4 and 6 ]

Other Outcome Measures:
  1. Physician's Lesion Assessment dichotomized into "success" and "failure" [ Time Frame: Week 6 ]
  2. Severity of Target Lesion EASI 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

Inclusion Criteria:

  • Male or female 18 to 70 years of age.
  • Clinical diagnosis of stable atopic dermatitis (AD) and with two lesions of similar size and have an identical score of at least 5 but no more than 9 on the sum of the individual components of the Eczema Area and Severity Index (EASI) at the Target Lesion scale.
  • Male or non-pregnant, non-lactating females.
  • Signed informed consent.

Exclusion Criteria:

  • Subjects who have unstable atopic dermatitis (AD).
  • Significant infection at the target lesion site.
  • Prior or concomitant use of systemic therapies for AD within the past 4 weeks. - Prior or concomitant use of topical treatments for AD, to within 10 cm of the target lesion within the past 4 weeks.
  • Prior or concomitant use of oral retinoids for AD within the last 6 months.
  • Use of biologics for AD within the past 3 months, or 5 half-lives (whichever is longer).
  • 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 identifier (NCT number): NCT01993420

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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.
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Study Director: Beth Zib Dermira, Inc.
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Responsible Party: Dermira, Inc. Identifier: NCT01993420    
Other Study ID Numbers: DRM02-ADM02
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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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases