Atopic DermatitisPhase 2NCT04154033
Treatment of Chronic Itch in Atopic Dermatitis With Topical Naltrexone
A Phase 2 study testing Naltrexone in people with Atopic Dermatitis and Pruritus, run by University of Minnesota at 1 site in United States.
Trial summary
To study the etiology and the epigenetic pathways leading to and regulating chronic itch. Similarly, to examine the mechanisms underlying skin changes, including epigenetic alterations while also testing the efficacy of medications, especially topical intervention. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atopic Dermatitis, Pruritus, Dermatitis
- What is being tested?
- Naltrexone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 31 Mar 2024
- Phase
- Phase 2
- 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
- Diagnosis of AD via simplified UK Working Group Criteria and a baseline PSGA score of 2 or greater
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Treatment of Chronic Itch in Atopic Dermatitis With Topical Naltrexone as Well as the Influence of Circadian Rhythm
To study the etiology and the epigenetic pathways leading to and regulating chronic itch. Similarly, to examine the mechanisms underlying skin changes, including epigenetic alterations while also testing the efficacy of medications, especially topical intervention. In this study, the investigators aim to examine chronic sensory disorder mechanisms related to chronic itch.
Read the detailed description
Itch was recently identified as one of the top three priority topics in dermatology at a Research Agenda Conference sponsored by the American Academy of Dermatology in 2012. Chronic itch is a complex phenomenon, involving the skin, immune and nervous systems to various degrees. Therefore, focusing on a particular pruritic disease will enable us to work out the underlying pathophysiological mechanisms that occur between the skin and the brain to establish a rational treatment approach.
Atopic Dermatitis (AD) is defined as a chronic inflammatory dermatological disease characterized by immunological and neurological cutaneous hyperreactivity with ongoing itch and inflammation. It is linked to an atopic predisposition with skin barrier abnormalities, recurrent delayed-type inflammations; frequently the development of IgE-mediated inhalant and gastrointestinal-related immediate type reactions. It is estimated that the prevalence for AD is at least 17% of the population lifetime worldwide with some reports of increasing prevalence in the last decades. It is also increasingly being observed in the aging population with dry, itchy skin.
Various topical and systemic therapies are available and choices are based on disease extent, presence of acute flare, and age of the patient. Unfortunately, itch in AD can be challenging to control; although multiple topical and systemic treatments are available, to date no universally accepted treatment exists.
The investigators have previously shown that opioid receptors play an important role in pruritus. Therefore, the investigators plan on expanding on previous and ongoing experiences with opioid antagonists and study the epigenetic and molecular mechanisms behind. Moreover, the investigators have recently discovered that the endogenous opioid ligand Met-Enkephalin influences circadian rhythm by binding directly to CLOCK gene promoters in the nucleus, which then change the amplitude and phase-shift these genes in keratinocytes.
Ultimately, the investigators would like to evaluate the effectiveness of topical application of Naltrexone in an effort to potentially help to treat chronic, untreatable itch and learn more about peripheral disorders of sensation (itch and pain).
- Conditions
- Atopic Dermatitis, Pruritus, Dermatitis
- Being tested
- Naltrexone, Placebo Cream
- Medical subject headings
- Dermatitis, Atopic, Pruritus, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
Topical naltrexone cream (1%)
Placebo CreamOther
Topical placebo cream
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Circadian Rhythm of Itch | No intervention | For the study arm A, to evaluate circadian rhythm of itching, patients will record for 7 days 6 times daily in a booklet the itch intensity on a visual analog scale (VAS) scale. These time points for itch intensity recording will be hours after time of awakening (AW), so they will be AW+2h, AW+4h, AW+6h, AW+8h, AW+10h, AW+12h. Patients are to document all their pruritus attacks at these time points. On day 8 the investigators will collect suction blisters (4-5 10mm blisters) at these 6 time points from unaffected skin on the trunk. For this purpose, the investigators will use the commercially available 47mm orifice plate (Electronic Diversities, Finksburg MD, USA) with 4-5 x10mm openings for each time point and use the 4-5 1mm blister roofs for harvesting. |
| Arm B: Topical Naltrexone Cream | Experimental | Patients will start with placebo in week 2 and move on to naltrexone treatment in week 3. There will be a wash-in phase during week 1. Following week 2 and week 3, at visits 3 and 4, patients will be asked for the area where they are experiencing most intense itch and the investigators will take suction blisters from that area before any treatment. They will be told to bring the medication they have been using and they will apply this topically. After an hour, another suction blister will be taken from the same area. This will ensure the study is still blinded as neither the physician or the participant will know whether the medication was a placebo or not. Participants may apply their topical treatment as often as he wishes. Receives: Drug: Naltrexone |
| Arm C: Placebo Cream | Placebo comparator | Patients will start with naltrexone treatment in week 2 and move on to placebo treatment in week 3. Other than this, all procedures will be the same as in study arm B. Receives: Other: Placebo Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale for Itching: Circadian 2 Hours AW
To assess the effects of circadian rhythm on pruritus, participants will record itch intensity using a visual analog scale (VAS) at the following time points after waking (AW): AW+2h for 7 days. VAS ranges from 0mm (no itch) to 100mm (unbearable itch). The mean (in millimeters) of 7 daily measurements will be reported.
Measured: 7 days
Visual Analog Scale for Itching: Circadian 4 Hours AW
To assess the effects of circadian rhythm on pruritus, participants will record itch intensity using a visual analog scale (VAS) at the following time points after waking (AW): AW+4h for 7 days. VAS ranges from 0mm (no itch) to 100mm (unbearable itch). The mean (in millimeters) of 7 daily measurements will be reported.
Measured: 7 days
Visual Analog Scale for Itching: Circadian 6 Hours AW
To assess the effects of circadian rhythm on pruritus, participants will record itch intensity using a visual analog scale (VAS) at the following time points after waking (AW): AW+6h for 7 days. VAS ranges from 0mm (no itch) to 100mm (unbearable itch). The mean (in millimeters) of 7 daily measurements will be reported.
Measured: 7 days
Visual Analog Scale for Itching: Circadian 8 Hours AW
To assess the effects of circadian rhythm on pruritus, participants will record itch intensity using a visual analog scale (VAS) at the following time points after waking (AW): AW+8h for 7 days. VAS ranges from 0mm (no itch) to 100mm (unbearable itch). The mean (in millimeters) of 7 daily measurements will be reported.
Measured: 7 days
Visual Analog Scale for Itching: Circadian 10 Hours AW
To assess the effects of circadian rhythm on pruritus, participants will record itch intensity using a visual analog scale (VAS) at the following time points after waking (AW): AW+10h for 7 days. VAS ranges from 0mm (no itch) to 100mm (unbearable itch). The mean (in millimeters) of 7 daily measurements will be reported.
Measured: 7 days
Visual Analog Scale for Itching: Circadian 12 Hours AW
To assess the effects of circadian rhythm on pruritus, participants will record itch intensity using a visual analog scale (VAS) at the following time points after waking (AW): AW+12h for 7 days. VAS ranges from 0mm (no itch) to 100mm (unbearable itch). The mean (in millimeters) of 7 daily measurements will be reported.
Measured: 7 days
Visual Analog Scale for Itching: Treatment 0 min
To assess the effects of naltrexone 1% or placebo cream on pruritus, participants will record itch intensity using a visual analog scale (VAS) at 0 minutes after applying cream for 3 pruritis attacks in 1 week. VAS ranges from 0mm (no itch) to 100mm (unbearable itch). The mean (in millimeters) over 3 pruritis attacks will be reported.
Measured: 0 minutes after applying topical cream
Visual Analog Scale for Itching: Treatment 20 min
To assess the effects of naltrexone 1% or placebo cream on pruritus, participants will record itch intensity using a visual analog scale (VAS) at 20 minutes after applying cream for 3 pruritis attacks in 1 week. VAS ranges from 0mm (no itch) to 100mm (unbearable itch). The mean (in millimeters) over 3 pruritis attacks will be reported.
Measured: 20 minutes after applying topical cream
Visual Analog Scale for Itching: Treatment 40 min
To assess the effects of naltrexone 1% or placebo cream on pruritus, participants will record itch intensity using a visual analog scale (VAS) at 40 minutes after applying cream for 3 pruritis attacks in 1 week. VAS ranges from 0mm (no itch) to 100mm (unbearable itch). The mean (in millimeters) over 3 pruritis attacks will be reported.
Measured: 40 minutes after applying topical cream
Visual Analog Scale for Itching: Treatment 1 Hour
To assess the effects of naltrexone 1% or placebo cream on pruritus, participants will record itch intensity using a visual analog scale (VAS) at 1 hour after applying cream for 3 pruritis attacks in 1 week. VAS ranges from 0mm (no itch) to 100mm (unbearable itch). The mean (in millimeters) over 3 pruritis attacks will be reported.
Measured: 1 hour after applying topical cream
Visual Analog Scale for Itching: Treatment 2 Hours
To assess the effects of naltrexone 1% or placebo cream on pruritus, participants will record itch intensity using a visual analog scale (VAS) at 2 hours after applying cream for 3 pruritis attacks in 1 week. VAS ranges from 0mm (no itch) to 100mm (unbearable itch). The mean (in millimeters) over 3 pruritis attacks will be reported.
Measured: 2 hours after applying topical cream
Visual Analog Scale for Itching: Treatment 3 Hours
To assess the effects of naltrexone 1% or placebo cream on pruritus, participants will record itch intensity using a visual analog scale (VAS) at 3 hours after applying cream for 3 pruritis attacks in 1 week. VAS ranges from 0mm (no itch) to 100mm (unbearable itch). The mean (in millimeters) over 3 pruritis attacks will be reported.
Measured: 3 hours after applying topical cream
Visual Analog Scale for Itching: Treatment 4 Hours
To assess the effects of naltrexone 1% or placebo cream on pruritus, participants will record itch intensity using a visual analog scale (VAS) at 4 hours after applying cream for 3 pruritis attacks in 1 week. VAS ranges from 0mm (no itch) to 100mm (unbearable itch). The mean (in millimeters) over 3 pruritis attacks will be reported.
Measured: 4 hours after applying topical cream
Secondary outcomes (2)
Time to Itching Intensity Decrease by 50%
Time to itching intensity decrease by 50% using visual analog scale (VAS) after applying topical cream (either naltrexone or placebo) for 3 pruritis attacks in 1 week. VAS ranges from 0mm (no itch) to 100mm (unbearable itch). VAS will be recorded at 6 time points after application (AA) of cream: 0minAA, 20minAA, 40minAA, 60minAA, 120minAA, 180minAA, and 240minAA. The mean value (in min AA) across 3 pruritis attacks in 1 week will be reported.
Measured: 4 hours
Total Reduction in Itch Intensity
The total reduction of itch intensity as measured by visual analog scale (VAS) after applying topical cream (either naltrexone or placebo). VAS ranges from 0mm (no itch) to 100mm (unbearable itch). Participants will measure itching via VAS at 0min after cream application and 4hr after cream application. Total reduction in itch will be measured in millimeters on VAS. The mean value (across 3 pruritis attacks in 1 week) will be reported.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start1 Oct 2020 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Bigliardi, MD, Principal investigator, University of Minenesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154033
- Sponsor's protocol ID
- DERM-2019-27870
- Status last verified
- Apr 2021
- First submitted
- 4 Nov 2019
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Itch in Atopic Dermatitis With Topical Naltrexone as Well as the Influence of Circadian Rhythm
- ClinicalTrials.gov ID
- NCT04154033
- Acronym / sponsor ID
- DERM-2019-27870
- Conditions
- Atopic Dermatitis, Pruritus, Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 6 Nov 2019 (actual)
- 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.
To study the etiology and the epigenetic pathways leading to and regulating chronic itch. Similarly, to examine the mechanisms underlying skin changes, including epigenetic alterations while also testing the efficacy of medications, especially topical intervention. In this study, the investigators aim to examine chronic sensory disorder mechanisms related to chronic itch.
Detailed description
Itch was recently identified as one of the top three priority topics in dermatology at a Research Agenda Conference sponsored by the American Academy of Dermatology in 2012. Chronic itch is a complex phenomenon, involving the skin, immune and nervous systems to various degrees. Therefore, focusing on a particular pruritic disease will enable us to work out the underlying pathophysiological mechanisms that occur between the skin and the brain to establish a rational treatment approach.
Atopic Dermatitis (AD) is defined as a chronic inflammatory dermatological disease characterized by immunological and neurological cutaneous hyperreactivity with ongoing itch and inflammation. It is linked to an atopic predisposition with skin barrier abnormalities, recurrent delayed-type inflammations; frequently the development of IgE-mediated inhalant and gastrointestinal-related immediate type reactions. It is estimated that the prevalence for AD is at least 17% of the population lifetime worldwide with some reports of increasing prevalence in the last decades. It is also increasingly being observed in the aging population with dry, itchy skin.
Various topical and systemic therapies are available and choices are based on disease extent, presence of acute flare, and age of the patient. Unfortunately, itch in AD can be challenging to control; although multiple topical and systemic treatments are available, to date no universally accepted treatment exists.
The investigators have previously shown that opioid receptors play an important role in pruritus. Therefore, the investigators plan on expanding on previous and ongoing experiences with opioid antagonists and study the epigenetic and molecular mechanisms behind. Moreover, the investigators have recently discovered that the endogenous opioid ligand Met-Enkephalin influences circadian rhythm by binding directly to CLOCK gene promoters in the nucleus, which then change the amplitude and phase-shift these genes in keratinocytes.
Ultimately, the investigators would like to evaluate the effectiveness of topical application of Naltrexone in an effort to potentially help to treat chronic, untreatable itch and learn more about peripheral disorders of sensation (itch and pain).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Circadian Rhythm of Itch | No intervention | –For the study arm A, to evaluate circadian rhythm of itching, patients will record for 7 days 6 times daily in a booklet the itch intensity on a visual analog scale (VAS) scale. These time points for itch intensity recording will be hours after time of awakening (AW), so they will be AW+2h, AW+4h, AW+6h, AW+8h, AW+10h, AW+12h. Patients are to document all their pruritus attacks at these time points. On day 8 the investigators will collect suction blisters (4-5 10mm blisters) at these 6 time points from unaffected skin on the trunk. For this purpose, the investigators will use the commercially available 47mm orifice plate (Electronic Diversities, Finksburg MD, USA) with 4-5 x10mm openings for each time point and use the 4-5 1mm blister roofs for harvesting. |
| Arm B: Topical Naltrexone Cream | Experimental | Drug: NaltrexonePatients will start with placebo in week 2 and move on to naltrexone treatment in week 3. There will be a wash-in phase during week 1. Following week 2 and week 3, at visits 3 and 4, patients will be asked for the area where they are experiencing most intense itch and the investigators will take suction blisters from that area before any treatment. They will be told to bring the medication they have been using and they will apply this topically. After an hour, another suction blister will be taken from the same area. This will ensure the study is still blinded as neither the physician or the participant will know whether the medication was a placebo or not. Participants may apply their topical treatment as often as he wishes. |
| Arm C: Placebo Cream | Placebo comparator | Other: Placebo CreamPatients will start with naltrexone treatment in week 2 and move on to placebo treatment in week 3. Other than this, all procedures will be the same as in study arm B. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of AD via simplified UK Working Group Criteria and a baseline PSGA score of 2 or greater
- 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 (18 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 |
|---|---|---|
| NaltrexoneTopical naltrexone cream (1%) | Drug | Arm B: Topical Naltrexone Cream |
| Placebo CreamTopical placebo cream | Other | Arm C: Placebo Cream |
Primary outcome
Visual Analog Scale for Itching: Circadian 2 Hours AW
Time frame: 7 days
To assess the effects of circadian rhythm on pruritus, participants will record itch intensity using a visual analog scale (VAS) at the following time points after waking (AW): AW+2h for 7 days. VAS ranges from 0mm (no itch) to 100mm (unbearable itch). The mean (in millimeters) of 7 daily measurements will be reported.
Visual Analog Scale for Itching: Circadian 4 Hours AW
Time frame: 7 days
To assess the effects of circadian rhythm on pruritus, participants will record itch intensity using a visual analog scale (VAS) at the following time points after waking (AW): AW+4h for 7 days. VAS ranges from 0mm (no itch) to 100mm (unbearable itch). The mean (in millimeters) of 7 daily measurements will be reported.
Visual Analog Scale for Itching: Circadian 6 Hours AW
Time frame: 7 days
To assess the effects of circadian rhythm on pruritus, participants will record itch intensity using a visual analog scale (VAS) at the following time points after waking (AW): AW+6h for 7 days. VAS ranges from 0mm (no itch) to 100mm (unbearable itch). The mean (in millimeters) of 7 daily measurements will be reported.
Visual Analog Scale for Itching: Circadian 8 Hours AW
Time frame: 7 days
To assess the effects of circadian rhythm on pruritus, participants will record itch intensity using a visual analog scale (VAS) at the following time points after waking (AW): AW+8h for 7 days. VAS ranges from 0mm (no itch) to 100mm (unbearable itch). The mean (in millimeters) of 7 daily measurements will be reported.
Visual Analog Scale for Itching: Circadian 10 Hours AW
Time frame: 7 days
To assess the effects of circadian rhythm on pruritus, participants will record itch intensity using a visual analog scale (VAS) at the following time points after waking (AW): AW+10h for 7 days. VAS ranges from 0mm (no itch) to 100mm (unbearable itch). The mean (in millimeters) of 7 daily measurements will be reported.
Visual Analog Scale for Itching: Circadian 12 Hours AW
Time frame: 7 days
To assess the effects of circadian rhythm on pruritus, participants will record itch intensity using a visual analog scale (VAS) at the following time points after waking (AW): AW+12h for 7 days. VAS ranges from 0mm (no itch) to 100mm (unbearable itch). The mean (in millimeters) of 7 daily measurements will be reported.
Visual Analog Scale for Itching: Treatment 0 min
Time frame: 0 minutes after applying topical cream
To assess the effects of naltrexone 1% or placebo cream on pruritus, participants will record itch intensity using a visual analog scale (VAS) at 0 minutes after applying cream for 3 pruritis attacks in 1 week. VAS ranges from 0mm (no itch) to 100mm (unbearable itch). The mean (in millimeters) over 3 pruritis attacks will be reported.
Visual Analog Scale for Itching: Treatment 20 min
Time frame: 20 minutes after applying topical cream
To assess the effects of naltrexone 1% or placebo cream on pruritus, participants will record itch intensity using a visual analog scale (VAS) at 20 minutes after applying cream for 3 pruritis attacks in 1 week. VAS ranges from 0mm (no itch) to 100mm (unbearable itch). The mean (in millimeters) over 3 pruritis attacks will be reported.
Visual Analog Scale for Itching: Treatment 40 min
Time frame: 40 minutes after applying topical cream
To assess the effects of naltrexone 1% or placebo cream on pruritus, participants will record itch intensity using a visual analog scale (VAS) at 40 minutes after applying cream for 3 pruritis attacks in 1 week. VAS ranges from 0mm (no itch) to 100mm (unbearable itch). The mean (in millimeters) over 3 pruritis attacks will be reported.
Visual Analog Scale for Itching: Treatment 1 Hour
Time frame: 1 hour after applying topical cream
To assess the effects of naltrexone 1% or placebo cream on pruritus, participants will record itch intensity using a visual analog scale (VAS) at 1 hour after applying cream for 3 pruritis attacks in 1 week. VAS ranges from 0mm (no itch) to 100mm (unbearable itch). The mean (in millimeters) over 3 pruritis attacks will be reported.
Visual Analog Scale for Itching: Treatment 2 Hours
Time frame: 2 hours after applying topical cream
To assess the effects of naltrexone 1% or placebo cream on pruritus, participants will record itch intensity using a visual analog scale (VAS) at 2 hours after applying cream for 3 pruritis attacks in 1 week. VAS ranges from 0mm (no itch) to 100mm (unbearable itch). The mean (in millimeters) over 3 pruritis attacks will be reported.
Visual Analog Scale for Itching: Treatment 3 Hours
Time frame: 3 hours after applying topical cream
To assess the effects of naltrexone 1% or placebo cream on pruritus, participants will record itch intensity using a visual analog scale (VAS) at 3 hours after applying cream for 3 pruritis attacks in 1 week. VAS ranges from 0mm (no itch) to 100mm (unbearable itch). The mean (in millimeters) over 3 pruritis attacks will be reported.
Visual Analog Scale for Itching: Treatment 4 Hours
Time frame: 4 hours after applying topical cream
To assess the effects of naltrexone 1% or placebo cream on pruritus, participants will record itch intensity using a visual analog scale (VAS) at 4 hours after applying cream for 3 pruritis attacks in 1 week. VAS ranges from 0mm (no itch) to 100mm (unbearable itch). The mean (in millimeters) over 3 pruritis attacks will be reported.
2 secondary outcomes
Time to Itching Intensity Decrease by 50%
Time frame: 4 hours
Total Reduction in Itch Intensity
Time frame: 4 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Paul Bigliardi, MD principal investigator
University of Minenesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Naltrexone in people with Atopic Dermatitis and Pruritus, 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 2 inclusion and 18 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: withdrawn, as of the sponsor's last update on 20 Apr 2021. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Visual Analog Scale for Itching: Circadian 2 Hours AW (time frame: 7 days). The study lists 13 primary outcomes in all. 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 20 Apr 2021.