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Phase 2 Completed N=126 Randomized Triple-blind Treatment

Treatment of Chronic Itch in Patients Under Arsenic Exposure With Naloxone

Source: ClinicalTrials.gov NCT03751111 ↗
Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Numeric Rating Scale for Itch — 6.42; 7.8 score on a scale (0~10)

Summary

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Numeric Rating Scale for Itch
6.42; 7.8
SECONDARY
Pittsburgh Sleep Quality Index (PSQI)
9.5; 10.0
SECONDARY
Serological Indicator
SECONDARY
Dermatology Life Quality Index (DLQI)
9.2; 12.1

Eligibility Criteria

Inclusion Criteria

  • Aged 18 years or over and without diseases except arsenic-related pruritus
  • Ability to study protocol and to give informed consent by himself/herself voluntarily
  • The number of male or female subjects is required more than 1/3 of the total number of subjects
  • Numeric Rating Sscale≥3 at the baseline
  • 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 oral anti-inflammatory medications for 2 weeks prior to the study start.
  • Use of 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 basic itchy dermatological diseases before such as eczema wich may influence the judgement of drug efficacy.
  • 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.
  • Lyme disease, porphyria, rheumatoid arthritis, Hansen's disease (leprosy) or use of antineoplastic chemotherapeutic agents.
  • Patients considered by researchers that are not suitable to the study.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03751111). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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