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Clinical Trial Details for Treatment of Chronic Itch in Atopic Dermatitis (Eczema)


University of Minnesota - Clinical and Translational Science Institute
NCT ID: NCT02268448
Last Updated: May 31, 2019

The Study at a Glance

  • Status: Recruiting
  • Phase: Phase 1
  • Gender: All
  • Age: 18 Years - 70 Years
  • Condition: Cutaneous Nerves CNS Itch
  • Study Type: Interventional
  • Intervention:
  • Lead Sponsor: University of Minnesota - Clinical and Translational Science Institute
  • Location: Not Provided

Official Title

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

Purpose

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.

Eligibility

Ages Eligible for Study

18 Years to 70 Years

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

Additional Information, Locations & Contacts

Sponsors & Collaborators

University of Minnesota - Clinical and Translational Science Institute

Investigators

Study Chair: Maria Hordinsky, MD

University of Minnesota - Clinical and Translational Science Institute

Please refer to this study by its ClinicalTrials.gov identifier: NCT02268448

Location

Contacts

University of Minnesota Department of Dermatology

Minneapolis, Minnesota 55414

United States

Irmina Wallander

derm@umn.edu