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Treatment of Chronic Itch in Atopic Dermatitis (Eczema)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02268448
Recruitment Status : Recruiting
First Posted : October 20, 2014
Last Update Posted : March 18, 2022
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cutaneous Nerves CNS Itch Drug: Clonidine Drug: Naltrexone Phase 1

Detailed Description:
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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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 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Itching

Arm Intervention/treatment
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.
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.
Drug: Naltrexone

Primary Outcome Measures :
  1. Reduction in Itch [ Time Frame: 3 month ]
    Participants will take personal surveys regarding the reduction in itching after 3 months

Information from the National Library of Medicine

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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:

  1. Age range 18-70 years old and ability to give informed consent and HIPAA authorization.
  2. 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).
  3. Diagnosis of AD via simplified UK Working Group Criteria and a baseline PSGA score of 2 or greater
  4. Willingness to adhere to study protocol
  5. 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:

  1. Use of topical or oral anti-inflammatory medications for 2 weeks prior to the study start.
  2. Use of topical or oral anti-histamines for 2 weeks prior to the study start.
  3. Use of topical or oral anti-pruritic agents for 2 weeks prior to the study start.
  4. Use of oral neuromodulatory agents for 2 months prior to study start.
  5. Current use of chronic pain medications (including opioids, antidepressants and anti-epileptic drugs).
  6. Use of nicotine-containing products for the past 6 months prior to study start.
  7. History of radiation or chemotherapy.
  8. History of traumatic injury on prospective test sites.
  9. Unstable thyroid function within the past 6 months prior to study start to exclude thyroid-related neuropathy (Duyff et al, 2000).
  10. Known history of central or peripheral nervous system dysfunction.
  11. History of acute hepatitis, chronic liver disease or end stage liver disease.
  12. History of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome.
  13. History of neuropathy associated with chronic obstructive pulmonary disease, diabetes mellitus, documented exposure to organophosphates or heavy metals or polychlorinated biphenyls.
  14. Known nutritional deficiency (vitamin B12, vitamin D, iron or zinc) within 3 months prior to the study start.
  15. Use of illicit drugs within the past 6 months prior to study start.
  16. History of daily use of power tools.
  17. Lyme disease, porphyria, rheumatoid arthritis, Hansen's disease (leprosy) or use of antineoplastic chemotherapeutic agents.
  18. Subject has any medical condition that, in the judgment of the Investigator, would jeopardize the subject's safety following exposure to the administered medications.
  19. Adults lacking capacity to consent

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): NCT02268448

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United States, Minnesota
University of Minnesota Department of Dermatology Recruiting
Minneapolis, Minnesota, United States, 55414
Contact: Irmina Wallander    612-624-5721   
Principal Investigator: Maria Hordinsky, MD         
Sub-Investigator: George Wilcox, PhD         
Sub-Investigator: Elizabeth Hurliman, MD         
Sponsors and Collaborators
University of Minnesota
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Study Chair: Maria Hordinsky, MD University of Minnesota
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Responsible Party: University of Minnesota Identifier: NCT02268448    
Other Study ID Numbers: DERM-2006-15390
First Posted: October 20, 2014    Key Record Dates
Last Update Posted: March 18, 2022
Last Verified: March 2022
Keywords provided by University of Minnesota:
itch atopic dermatitis
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
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antihypertensive Agents
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action