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

Primary Purpose

Cutaneous Nerves CNS Itch

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Clonidine
Naltrexone
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Nerves CNS Itch focused on measuring itch atopic dermatitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Clonidine

Naltrexone

Arm Description

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 will be given to each subject at an oral dose of 50 mg daily. Subjects will self-administer the drug at bedtime.

Outcomes

Primary Outcome Measures

Reduction in Itch
Participants will take personal surveys regarding the reduction in itching after 3 months

Secondary Outcome Measures

Full Information

First Posted
October 9, 2014
Last Updated
January 23, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02268448
Brief Title
Treatment of Chronic Itch in Atopic Dermatitis (Eczema): Nerve Function
Official Title
Treatment of Chronic Itch in Atopic Dermatitis With Oral Clonidine and Oral Naltrexone: Nerve Function
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
September 2022 (Actual)
Study Completion Date
September 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Nerves CNS Itch
Keywords
itch atopic dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clonidine
Arm Type
Experimental
Arm Description
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.
Arm Title
Naltrexone
Arm Type
Experimental
Arm Description
Naltrexone will be given to each subject at an oral dose of 50 mg daily. Subjects will self-administer the drug at bedtime.
Intervention Type
Drug
Intervention Name(s)
Clonidine
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Primary Outcome Measure Information:
Title
Reduction in Itch
Description
Participants will take personal surveys regarding the reduction in itching after 3 months
Time Frame
3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Hordinsky, MD
Organizational Affiliation
University of Minnesota
Official's Role
Study Chair
Facility Information:
Facility Name
University of Minnesota Department of Dermatology
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States

12. IPD Sharing Statement

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

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