Chronic Pruritus Clinical Trial
Official title:
Treatment of Chronic Itch in Patients Under Arsenic Exposure With Sublingual Naloxone: A Single-blind Randomized Trial
Verified date | April 2019 |
Source | Xiangya Hospital of Central South University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess the efficacy and safety of sublingual naloxone in the treatment of chronic itch in patients under arsenic exposure.
Status | Completed |
Enrollment | 100 |
Est. completion date | March 30, 2019 |
Est. primary completion date | March 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Aged 18 years or over and without diseases except arsenic-related pruritus 2. Ability to study protocol and to give informed consent by himself/herself voluntarily 3. The number of male or female subjects is required more than 1/3 of the total number of subjects 4. Hair arsenic concentration=1 µg/g 5. Numeric Rating Sscale=3 at the baseline 6. 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: 1. Use of oral anti-inflammatory medications for 2 weeks prior to the study start. 2. Use of oral anti-histamines for 2 weeks prior to the study start. 3. Use of topical or oral anti-pruritic agents for 2 weeks prior to the study start. 4. Use of oral neuromodulatory agents for 2 months prior to study start. 5. Current use of chronic pain medications (including opioids, antidepressants and anti-epileptic drugs). 6. Use of nicotine-containing products for the past 6 months prior to study start. 7. History of basic itchy dermatological diseases before such as eczema wich may influence the judgement of drug efficacy. 8. Unstable thyroid function within the past 6 months prior to study start to exclude thyroid-related neuropathy. 9. Known history of central or peripheral nervous system dysfunction. 10. History of acute hepatitis, chronic liver disease or end stage liver disease. 11. History of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome. 12. History of neuropathy associated with chronic obstructive pulmonary disease, diabetes mellitus, documented exposure to organophosphates or heavy metals or polychlorinated biphenyls. 13. Known nutritional deficiency (vitamin B12, vitamin D, iron or zinc) within 3 months prior to the study start. 14. Use of illicit drugs within the past 6 months prior to study start. 15. Lyme disease, porphyria, rheumatoid arthritis, Hansen's disease (leprosy) or use of antineoplastic chemotherapeutic agents. 16. Patients considered by researchers that are not suitable to the study. |
Country | Name | City | State |
---|---|---|---|
China | Xiangya Hospital | Changsha | Hunan |
Lead Sponsor | Collaborator |
---|---|
Xiangya Hospital of Central South University |
China,
Xiao Y, Huang X, Jing D, Huang Y, Zhang X, Shu Z, Huang Z, Su J, Li J, Zhang J, Chen M, Chen X, Shen M. Assessment of the Dermatology Life Quality Index (DLQI) in a homogeneous population under lifetime arsenic exposure. Qual Life Res. 2018 Dec;27(12):3209-3215. doi: 10.1007/s11136-018-1969-2. Epub 2018 Sep 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in symptom of itch | Participants will be asked to report the severity of itch using a numeric rating scale (NRS) at the baseline and week 1 of the trial | 1 week | |
Secondary | Sleeping quality | Measured by the Pittsburgh Sleep Quality Index at baseline and week 1 of the trial | 1 week | |
Secondary | Serological indicator | Level of serum beta-endorphin will be tested at baseline and week 1 of the trial | 1 week | |
Secondary | Health-related quality of life | Dermatology Life Quality Index (DLQI) at baseline and week 1 of the trial | 1 week |
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