Status:
COMPLETED
Treatment of Chronic Itch in Atopic Dermatitis (Eczema): Nerve Function
Lead Sponsor:
University of Minnesota
Conditions:
Cutaneous Nerves CNS Itch
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 wit...
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 derm...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02268448
Start Date
July 1 2015
End Date
September 1 2022
Last Update
January 26 2023
Active Locations (1)
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1
University of Minnesota Department of Dermatology
Minneapolis, Minnesota, United States, 55414