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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
Pivotal Trial

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

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

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

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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
~7 spots leftby Nov 2025
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