Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT04325802
Eligibility Criteria:
Inclusion Criteria:
* 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
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 (as rescue medication allowed).
* 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
* 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 and/or opioid use disorder.
* Regular use of opioids for chronic pain
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04325802
Study Brief:
Protocol Section:
NCT04325802