Purpose

This multi-center, double-blind, vehicle-controlled, randomized crossover design study will evaluate the safety and efficacy of topically applied naloxone lotion, 0.5%, for the treatment of pruritus in patients with the mycosis fungoides (MF) or Sézary syndrome (SS) Forms of Cutaneous T-cell Lymphoma (CTCL). This study will also determine if there is systemic absorption of the drug in a subset of subjects and if so, describe the range and mean plasma levels reached after two weeks of three time daily (TID) dosing. Funding Source - FDA OOPD

Conditions

Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

All subjects must meet the following criteria for admission into the study:

1. Signed informed consent has been obtained.

2. Subject is at least 21 years of age.

3. Diagnosis of mycosis fungoides (MF) or Sézary syndrome (SS) will be based on a combination of histological, clinical, and immunophenotypical criteria. The histological criteria will be based on skin biopsy from the most representative skin area. The diagnostic criteria used for each subject will be specified in the case report forms and the specific classification of MF or SS will be identified. The TNMB system will be used to classify the stage of disease (See Section 8.4 for details).

4. Completion of the mSWAT assessment.

5. A history of pruritus that meets following criteria:

At Screening Day -7:

- present on a daily basis for greater than one month prior to Screening Day -7,

- NRS for Pruritus score ≥5 as rated by the subject at the Day -7 Visit. Note: If the score is <5 and subject is taking or has taken a medication which may be affecting pruritus (e.g. systemic antihistamine or topical steroid), and if Investigator and subject agree, subject may washout or continue washout of medication and return for Day -7 Visit procedures after washout.

At Baseline Period 1 Day 0:

- NRS for Pruritus score of at least 5 recorded in the subject diary on at least 4 of the 7 days preceding Baseline Period 1 Day 0.

6. Pruritic treatment area of 5-95% of the subject's total treatable body surface area.

7. Subject can be expected to reliably follow treatment instructions and visit schedule.

8. Non-pregnant, non-lactating females of childbearing potential who agree to use medically acceptable forms of birth control (abstinence, hormonal contraceptives, diaphragm with spermicide, condom with spermicide, or intrauterine device) throughout the study or females of non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year). A negative urine pregnancy test must be confirmed at Baseline screening for all female subjects who are not post-menopausal > 1 year or surgically sterile.

9. The subject agrees not to begin any new concomitant medications during their participation in the study, with the exception of medications necessary to treat infection, and to continue any concomitant medication throughout the study.

10. Subject has no visual or motor impairments that will make it difficult to complete the Daily Diary or apply the study medication.

11. Subject is able to speak, read, and write English and agrees to participate and comply with the study procedures.

12. Subject has a body mass index (BMI) between 18.5 and 30.5 kglm2 (see Appendix C, Body Mass Index Table) (subjects in PK subset only).

Exclusion Criteria

Subjects meeting any of the following criteria will be excluded from study participation:

1. Pregnant or lactating female.

2. History of clinically significant heart failure.

3. Myocardial infarction within the past six months.

4. A history of ventricular arrhythmia requiring treatment.

5. Any medical condition which would, in the Investigator's opinion, preclude the subject from successfully participating in the study.

6. A known allergy to naloxone hydrochloride or any excipient in the formulation.

7. Previous naloxone use for pruritus.

8. Positive urine drug screen at Day 0 for opiates. Positive urine drug screen for anything other than opiates not explained, e.g., by concomitant medication, would also exclude the subject.

9. Treatment with any of the following during the restricted time period prior to Day -7, and at any time during the study, is not allowed:

Medication/Treatment Restriction:

Systemic narcotic analgesics (e.g. morphine, codeine) 7 days, Topical antihistamines to any skin surface [e.g. Zonalon® (doxepin)] 7 days, Other investigational drugs (excluding any therapies for the treatment of MF or SS) 30 days

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Naloxone Hydrochloride Lotion, 0.5%
Naloxone Hydrochloride Lotion 0.5%
  • Drug: Naloxone Hydrochloride Lotion, 0.5%
    Topical TID for 2 weeks
Placebo Comparator
Placebo Lotion
Placebo Lotion
  • Drug: Placebo Lotion
    Topical TID for 2 weeks

Recruiting Locations

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Chris Golden
501-686-8174
cdgolden@uams.edu

City of Hope
Duarte, California 91010
Contact:
Donna Bui
626-256-4673
dbui@coh.org

Stanford University
Palo Alto, California 94304
Contact:
Sydney Yee
650-721-6118
sydneyy@stanford.edu

USSF Health Morsani Center for Advanced Healthcare
Tampa, Florida 33612
Contact:
Rachel Karlnoski
813-396-9172
crc@health.usf.edu

Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois 60611
Contact:
Olga Lipiszko
312-503-6568
olga.lipiszko@northwestern.edu

Rush University Medical Center
Chicago, Illinois 60612
Contact:
Carmen Petrizzo
312-563-4001
carmen_m_petrizzo@rush.edu

Tulane University Health Sciences Center
New Orleans, Louisiana 70112
Contact:
Edward Coleman
504-988-5135
ecoleman@tulane.edu

Massachusetts General Hospital CURTIS
Boston, Massachusetts 02114
Contact:
Mary Cueva
617-726-5066
harvardskinstudies@partners.org

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Elizabeth Pottier
617-638-8260
elizabeth.pottier@bmc.org

University of Minnesota
Minneapolis, Minnesota 55455
Contact:
Jill Bengtson
612-626-8681
jeronco@umn.edu

St. Louis University Dermatology
Saint Louis, Missouri 63104
Contact:
Kristen Polito
314-256-3404
kristen.polito@health.slu.edu

Washington University School of Medicine St. Louis
Saint Louis, Missouri 63110
Contact:
Mary Tabacchi
mtabacchi@wustl.edu

Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756
Contact:
Debra J Rodgers
603-650-3693
debra.j.rodgers@hitchcock.org

Duke University Medical Center
Durham, North Carolina 27710
Contact:
Olivia Kohrman
919-668-5610
olivia.kohrman@duke.edu

University of Pennsylvania
Philadelphia, Pennsylvania 19104
Contact:
Deborah Leahy
deborah.leahy@upenn.edu

Jefferson Dermatology Associates
Philadelphia, Pennsylvania 19107
Contact:
Nish Vadalia
215-955-9295
nish.vadalia@jefferson.edu

UPMC Department of Dermatology
Pittsburgh, Pennsylvania 15213
Contact:
Sue A. McCann
412-864-3681

Vanderbilt Dermatology
Nashville, Tennessee 37204
Contact:
Ellie Dahms
615-875-1725
ellie.m.dahms@vumc.org

University of Texas South Western Medical Center
Dallas, Texas 75390
Contact:
Seli Gyau
seli.gyau@utsouthwestern.edu

University of Texas MD Anderson Cancer Center
Houston, Texas 77030
Contact:
Auris Huen, MD
713-745-1113
aohuen@mdanderson.org

Inova Schar Cancer Institute
Fairfax, Virginia 22031
Contact:
Kelly Jerffords
703-970-6548
kelly.jeffords@inova.org

University of Washington / Seattle Cancer Care Alliance (SCCA)
Seattle, Washington 98109
Contact:
Niall Curley
206-606-1231
ncurley8@seattlecca.org

More Details

NCT ID
NCT02811783
Status
Recruiting
Sponsor
Elorac, Inc.

Study Contact

Scott B Phillips, MD
8473628200
scott@eloracpharma.com

Detailed Description

There will be 160 subjects enrolled in the study. The study consists of a Screening Period of up to 7 days during which inclusion / exclusion criteria will be reviewed. Subjects meeting inclusion / exclusion criteria including the diagnostic criteria for MF or SS and a score of at least 5 on the 11-Point Numeric Rating Scale (NRS) for Pruritus will complete the one week Screening Period. Subjects will complete a daily diary for NRS for Pruritus scores and Sleep scores. At the end of the Screening Period, subjects who have a NRS for Pruritus score of at least 5 recorded in the diary on at least 4 of the 7 days preceding Day 0 will be eligible to continue. Baseline assessments will be recorded for vital signs, pruritic body surface area, skin integrity, PQOL, and laboratory results. The Baseline period will be followed by a 2 week Treatment Period 1 in which subjects will be randomized to Naloxone Lotion 0.5% or Placebo Lotion to be applied TID for 14 days. During the 2 week Treatment Period subjects will complete daily diaries of NRS for Pruritis scores and Sleep scores. On Day 14 subjects will return to the clinic to review diaries, adverse events (AEs), concomitant medications, and to record body surface area for pruritus, skin integrity, PQOL, and laboratory results. Subjects will then enter a Washout Period for up to 56 days until the subject again scores at least 5 on the NRS for Pruritus on 4 consecutive or 4 of the past 7 days or 56 days pass. Subjects will then enter a 2 week Treatment Period 2 during which the same procedures as Treatment Period 1 will be performed except subjects will receive the alternate treatment to that assigned in Treatment Period 1.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.