A Safety and Efficacy of DRM02 in Subjects With Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT01993420|
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : April 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: DRM02 Other: Vehicle||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
DRM02 Topical Gel, 0.25%
Placebo Comparator: Vehicle
DRM02 Topical Gel, Vehicle
- Change in Physician's Lesion Assessment [ Time Frame: Week 6 ]
- Physician's Lesion Assessment analyzed for treatment effect [ Time Frame: From baseline to weeks 1, 2, 3, 4 and 6 ]
- Physician's Lesion Assessment dichotomized into "success" and "failure" [ Time Frame: Week 6 ]
- Severity of Target Lesion EASI scores [ Time Frame: Week 6 ]
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): NCT01993420
|Clinique Médicale Dr Isabelle Delorme|
|Drummondville, Quebec, Canada, J2B5L4|
|Innovaderm Research, Inc|
|Montreal, Quebec, Canada, H2K 4L5|
|Study Director:||Beth Zib||Dermira, Inc.|