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Opioid Antagonist

Naloxone Hydrochloride Lotion, 0.5% for Cutaneous T-Cell Lymphoma

Phase 3
Waitlist Available
Research Sponsored by Elorac, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and day 14 of each treatment period
Awards & highlights

Study Summary

This trial will study the safety and effectiveness of a naloxone lotion for treating itchiness in patients with mycosis fungoides or Sézary syndrome, both forms of cutaneous T-cell lymphoma. The study will also see if the drug is absorbed into the bloodstream and, if so, measure the plasma levels reached after two weeks of use.

Eligible Conditions
  • Cutaneous T-Cell Lymphoma
  • Mycosis Fungoides
  • Sézary Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and day 14 of each treatment period
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and day 14 of each treatment period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Numeric Rating Scale (NRS) for Pruritus
Secondary outcome measures
Categorical Rating Scale (CRS) for Skin Integrity
Numeric Rating Scale for Pruritus
Numeric Rating Scale for Sleep
+2 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Naloxone Hydrochloride Lotion, 0.5%Active Control1 Intervention
Naloxone Hydrochloride Lotion 0.5%
Group II: Placebo LotionPlacebo Group1 Intervention
Placebo Lotion

Find a Location

Who is running the clinical trial?

Elorac, Inc.Lead Sponsor
2 Previous Clinical Trials
127 Total Patients Enrolled
Scott B Phillips, MDStudy DirectorElorac, Inc.
2 Previous Clinical Trials
33 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL
2017. "Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02811783.
~7 spots leftby Apr 2025
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