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

NCT02268448 | Completed Phase 1 DMC

• 1 other identifier: DERM-2006-15390
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Nerves CNS Itch

Keywords

itch atopic dermatitis

Outcome Measures

Primary Outcomes (1)

• Reduction in Itch

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

  3 month

Study Arms (2)

Clonidine

EXPERIMENTAL

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

Naltrexone

EXPERIMENTAL

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

Interventions

Clonidine DRUG

Clonidine

Naltrexone DRUG

Naltrexone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Department of Dermatology

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Interventions

Clonidine; Naltrexone

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Maria Hordinsky, MD

  University of Minnesota

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: October 20, 2014
• Study Start: July 1, 2015
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

US (1)