Atopic Dermatitis Clinical Trial
Official title:
Treatment of Chronic Itch in Atopic Dermatitis With Topical Naltrexone as Well as the Influence of Circadian Rhythm
Verified date | April 2021 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 31, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 7 days | |
Primary | 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. | 7 days | |
Primary | 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. | 7 days | |
Primary | 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. | 7 days | |
Primary | 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. | 7 days | |
Primary | 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. | 7 days | |
Primary | 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. | 0 minutes after applying topical cream | |
Primary | 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. | 20 minutes after applying topical cream | |
Primary | 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. | 40 minutes after applying topical cream | |
Primary | 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. | 1 hour after applying topical cream | |
Primary | 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. | 2 hours after applying topical cream | |
Primary | 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. | 3 hours after applying topical cream | |
Primary | 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. | 4 hours after applying topical cream | |
Secondary | 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. | 4 hours | |
Secondary | 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. | 4 hours |
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