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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DRM02 | Experimental | DRM02 Topical Gel, 0.25% |
|
| Vehicle | Placebo Comparator | DRM02 Topical Gel, Vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DRM02 | Drug |
| ||
| Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physician's Lesion Assessment | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Physician's Lesion Assessment analyzed for treatment effect | From baseline to weeks 1, 2, 3, 4 and 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Physician's Lesion Assessment dichotomized into "success" and "failure" | Week 6 | |
| Severity of Target Lesion EASI scores | Week 6 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beth Zib | Dermira, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Médicale Dr Isabelle Delorme | Drummondville | Quebec | J2B5L4 | Canada | ||
| Innovaderm Research, Inc |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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|
| Montreal |
| Quebec |
| H2K 4L5 |
| Canada |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |