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The purpose of this study is to assess the safety and efficacy of oral clonidine in subjects with symptomatic atopic dermatitis and to assess the safety and efficacy of oral naltrexone in subjects with symptomatic atopic dermatitis.
This study will serve as a pilot study to determine the efficacy and safety of two novel oral agents (clonidine, naltrexone) in the treatment of chronic, non-experimentally induced itch in atopic dermatitis. In this study, eight subjects with symptomatic atopic dermatitis will be recruited and treated with either oral clonidine (four subjects) or oral naltrexone (four subjects) . Disease burden will be evaluated before and after 4 weeks of treatment through reporting of subjective symptomatology via surveys/questionnaire, neurometer study, and clinical assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clonidine | Experimental | Clonidine will be given orally as a starting dose of 0.1 mg daily. The drug will be administered orally by the subject at bedtime daily for four weeks. |
|
| Naltrexone | Experimental | Naltrexone will be given to each subject at an oral dose of 50 mg daily. Subjects will self-administer the drug at bedtime. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clonidine | Drug |
| ||
| Naltrexone |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Itch | Participants will take personal surveys regarding the reduction in itching after 3 months | 3 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Hordinsky, MD | University of Minnesota | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Department of Dermatology | Minneapolis | Minnesota | 55414 | United States |
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| ID | Term |
|---|---|
| D003000 | Clonidine |
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| D006571 |
| Heterocyclic Compounds |
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |