Cutaneous Nerves CNS ItchPhase 1NCT02268448
Treatment of Chronic Itch in Atopic Dermatitis (Eczema): Nerve Function
A Phase 1 study testing Clonidine and Naltrexone in people with Cutaneous Nerves CNS Itch, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cutaneous Nerves CNS Itch
- What is being tested?
- Clonidine and Naltrexone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Department of Dermatology
Minneapolis, Minnesota, 55414
About this study
Official title: 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.
Read the 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.
- Conditions
- Cutaneous Nerves CNS Itch
- Being tested
- Clonidine, Naltrexone
- Keywords
- itch atopic dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonidineDrug
NaltrexoneDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Itch
Participants will take personal surveys regarding the reduction in itching after 3 months
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startJul 2015
- Primary completionSep 2022
- Study completionSep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Nerves CNS ItchStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Hordinsky, MD, Study chair, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268448
- Sponsor's protocol ID
- DERM-2006-15390
- Status last verified
- Jan 2023
- First submitted
- 9 Oct 2014
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Itch in Atopic Dermatitis With Oral Clonidine and Oral Naltrexone: Nerve Function
- ClinicalTrials.gov ID
- NCT02268448
- Acronym / sponsor ID
- DERM-2006-15390
- Conditions
- Cutaneous Nerves CNS Itch
- Keywords
- itch atopic dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Sep 2022 (actual)
- Study completion
- Sep 2022 (actual)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clonidine | Experimental | Drug: ClonidineClonidine 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 | Experimental | Drug: NaltrexoneNaltrexone will be given to each subject at an oral dose of 50 mg daily. Subjects will self-administer the drug at bedtime. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clonidine | Drug | Clonidine |
| Naltrexone | Drug | Naltrexone |
Primary outcome
Reduction in Itch
Time frame: 3 month
Participants will take personal surveys regarding the reduction in itching after 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Hordinsky, MD study chair
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Clonidine and Naltrexone in people with Cutaneous Nerves CNS Itch, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Itch (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.