Treatment of Chronic Itch in Atopic Dermatitis (Eczema)
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ClinicalTrials.gov Identifier: NCT02268448 |
Recruitment Status :
Recruiting
First Posted : October 20, 2014
Last Update Posted : August 27, 2020
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Condition or disease | Intervention/treatment | Phase |
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Cutaneous Nerves CNS Itch | Drug: Clonidine Drug: Naltrexone | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 8 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Treatment of Chronic Itch in Atopic Dermatitis With Oral Clonidine and Oral Naltrexone |
Study Start Date : | July 2015 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | December 2022 |

Arm | Intervention/treatment |
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Experimental: Clonidine
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.
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Drug: Clonidine |
Experimental: Naltrexone
Naltrexone will be given to each subject at an oral dose of 50 mg daily. Subjects will self-administer the drug at bedtime.
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Drug: Naltrexone |
- Reduction in Itch [ Time Frame: 3 month ]Participants will take personal surveys regarding the reduction in itching after 3 months

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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:
- Age range 18-70 years old and ability to give informed consent and HIPAA authorization.
- Female subjects of childbearing potential must have a negative pregnancy test, and must agree to practice two methods of effective birth control during the study period as clonidine is an FDA pregnancy category C drug (including abstinence, oral or implant contraceptives or condoms).
- Diagnosis of AD via simplified UK Working Group Criteria and a baseline PSGA score of 2 or greater
- Willingness to adhere to study protocol
- Subjects taking hormone-containing medications must be on a stable dose for 6 months prior to study start to avoid any confounding influence on sensory and pain perception
Exclusion Criteria:
- Use of topical or oral anti-inflammatory medications for 2 weeks prior to the study start.
- Use of topical or oral anti-histamines for 2 weeks prior to the study start.
- Use of topical or oral anti-pruritic agents for 2 weeks prior to the study start.
- Use of oral neuromodulatory agents for 2 months prior to study start.
- Current use of chronic pain medications (including opioids, antidepressants and anti-epileptic drugs).
- Use of nicotine-containing products for the past 6 months prior to study start.
- History of radiation or chemotherapy.
- History of traumatic injury on prospective test sites.
- Unstable thyroid function within the past 6 months prior to study start to exclude thyroid-related neuropathy (Duyff et al, 2000).
- Known history of central or peripheral nervous system dysfunction.
- History of acute hepatitis, chronic liver disease or end stage liver disease.
- History of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome.
- History of neuropathy associated with chronic obstructive pulmonary disease, diabetes mellitus, documented exposure to organophosphates or heavy metals or polychlorinated biphenyls.
- Known nutritional deficiency (vitamin B12, vitamin D, iron or zinc) within 3 months prior to the study start.
- Use of illicit drugs within the past 6 months prior to study start.
- History of daily use of power tools.
- Lyme disease, porphyria, rheumatoid arthritis, Hansen's disease (leprosy) or use of antineoplastic chemotherapeutic agents.
- Subject has any medical condition that, in the judgment of the Investigator, would jeopardize the subject's safety following exposure to the administered medications.
- Adults lacking capacity to consent

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): NCT02268448
United States, Minnesota | |
University of Minnesota Department of Dermatology | Recruiting |
Minneapolis, Minnesota, United States, 55414 | |
Contact: Irmina Wallander 612-624-5721 derm@umn.edu | |
Principal Investigator: Maria Hordinsky, MD | |
Sub-Investigator: George Wilcox, PhD | |
Sub-Investigator: Elizabeth Hurliman, MD |
Study Chair: | Maria Hordinsky, MD | University of Minnesota |
Responsible Party: | University of Minnesota |
ClinicalTrials.gov Identifier: | NCT02268448 |
Other Study ID Numbers: |
DERM-2006-15390 |
First Posted: | October 20, 2014 Key Record Dates |
Last Update Posted: | August 27, 2020 |
Last Verified: | August 2020 |
itch atopic dermatitis |
Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Clonidine Naltrexone Alcohol Deterrents Narcotic Antagonists |
Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Analgesics Antihypertensive Agents Sympatholytics Autonomic Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |