Treatment of Chronic Itch in Atopic Dermatitis (Eczema): Nerve Function

January 23, 2023 updated by: University of Minnesota

Treatment of Chronic Itch in Atopic Dermatitis With Oral Clonidine and Oral Naltrexone: Nerve Function

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • University of Minnesota Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Itch
Time Frame: 3 month
Participants will take personal surveys regarding the reduction in itching after 3 months
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

October 9, 2014

First Submitted That Met QC Criteria

October 15, 2014

First Posted (Estimate)

October 20, 2014

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DERM-2006-15390

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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