Treatment of Chronic Itch in Atopic Dermatitis (Eczema)

• ClinicalTrials.gov Identifier: NCT02268448
• Recruitment Status: Recruiting
• First Posted: October 20, 2014
• Last Update Posted: January 7, 2020
• Sponsor: University of Minnesota
• Information provided by (Responsible Party): University of Minnesota

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

University of Minnesota

Investigators

• Study Chair: Maria Hordinsky, MD; University of Minnesota

More Information

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT02268448
• Other Study ID Numbers: 0610M95566
• First Posted: October 20, 2014
• Last Update Posted: January 7, 2020
• Last Verified: January 2020

Keywords provided by University of Minnesota:

itch atopic dermatitis

Additional relevant MeSH terms:

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