Ignite Creation Date:
2024-05-06 @ 1:53 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04154033
Status:
WITHDRAWN
Last Update Posted:
2021-04-20
First Post:
2019-11-04
Brief Title:
Treatment of Chronic Itch in Atopic Dermatitis With Topical Naltrexone
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Treatment of Chronic Itch in Atopic Dermatitis With Topical Naltrexone as Well as the Influence of Circadian Rhythm
Status:
WITHDRAWN
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None