Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL
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|ClinicalTrials.gov Identifier: NCT02811783|
Recruitment Status : Terminated (Sponsor decision)
First Posted : June 23, 2016
Last Update Posted : October 28, 2022
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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
|Condition or disease||Intervention/treatment||Phase|
|Mycosis Fungoides Lymphoma, T-Cell, Cutaneous Sézary Syndrome||Drug: Naloxone Hydrochloride Lotion, 0.5% Drug: Placebo Lotion||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Double Blind Randomized Vehicle Controlled Crossover Study to Evaluate the Safety and Efficacy of Topical Naloxone Hydrochloride Lotion 0.5% for the Relief of Pruritus in Patients With the MF or SS Forms of Cutaneous T-Cell Lymphoma|
|Actual Study Start Date :||January 2017|
|Actual Primary Completion Date :||September 2022|
|Actual Study Completion Date :||September 2022|
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
Drug: Placebo Lotion
Topical TID for 2 weeks
- Numeric Rating Scale (NRS) for Pruritus [ Time Frame: Baseline and 2 Weeks ]Change from Baseline to Day 14 in average NRS for Pruritus for each Treatment Period
- Responder Analysis - The difference in the proportion of subjects with a meaningful clinically significant improvement at the end of the two periods. [ Time Frame: Baseline and 2 Weeks ]The difference in the proportion of subjects with a meaningful clinically significant improvement at the end of the two periods. A clinically significant improvement is defined as an improvement of at least one category on the 4-point (none, mild, moderate, severe) Likert Scale verbal rating scale (VRS) and at least two points on the 11-point NRS for Pruritus. The NRS for Pruritus scores will be converted to VRS scores as follows for the analysis: 0=none, 1-3=mild, 4-6=moderate, and 7-10=severe.
- Numeric Rating Scale for Sleep [ Time Frame: Baseline and 1 and 2 weeks ]The change from Baseline at each week of the NRS for Sleep average score for each Treatment Period.
- Numeric Rating Scale for Pruritus [ Time Frame: Baseline and 1 week ]The change from Baseline at Week 1 of the NRS for Pruritus average score for each Treatment Period.
- Categorical Rating Scale (CRS) for Skin Integrity [ Time Frame: Baseline and 2 weeks ]The change from Baseline at Week 2 of the CRS for Skin Integrity for each Treatment Period.
- Pruritus Quality of Life Score (PQOL) [ Time Frame: Baseline and Day 14 of each Treatment period ]The change from Baseline in the final categorization of the PQOL at Day 14 of each Treatment Period
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||21 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
All subjects must meet the following criteria for admission into the study:
- Signed informed consent has been obtained.
- Subject is at least 21 years of age.
- 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).
- Completion of the mSWAT assessment.
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.
- Pruritic treatment area of 5-95% of the subject's total treatable body surface area.
- Subject can be expected to reliably follow treatment instructions and visit schedule.
- 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.
- 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.
- Subject has no visual or motor impairments that will make it difficult to complete the Daily Diary or apply the study medication.
- Subject is able to speak, read, and write English and agrees to participate and comply with the study procedures.
- 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).
Subjects meeting any of the following criteria will be excluded from study participation:
- Pregnant or lactating female.
- History of clinically significant heart failure.
- Myocardial infarction within the past six months.
- A history of ventricular arrhythmia requiring treatment.
- Any medical condition which would, in the Investigator's opinion, preclude the subject from successfully participating in the study.
- A known allergy to naloxone hydrochloride or any excipient in the formulation.
- Previous naloxone use for pruritus.
- 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.
- 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:
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811783
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|Palo Alto, California, United States, 94304|
|United States, Florida|
|USSF Health Morsani Center for Advanced Healthcare|
|Tampa, Florida, United States, 33612|
|Cleveland Clinic Indian River Hospital|
|Vero Beach, Florida, United States, 32960|
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60611|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|United States, Indiana|
|Dawes Fretzin Clinical Research Group, LLC|
|Indianapolis, Indiana, United States, 46250|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|United States, Missouri|
|St. Louis University Dermatology|
|Saint Louis, Missouri, United States, 63104|
|Washington University School of Medicine St. Louis|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|Stony Brook Dermatology|
|Stony Brook, New York, United States, 11790|
|United States, Ohio|
|University Hospitals Cleveland Medical Center|
|Cleveland, Ohio, United States, 44106|
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|United States, Virginia|
|Inova Schar Cancer Institute|
|Fairfax, Virginia, United States, 22031|
|United States, Washington|
|University of Washington / Seattle Cancer Care Alliance (SCCA)|
|Seattle, Washington, United States, 98109|
|Study Director:||Scott B Phillips, MD||Elorac, Inc.|
|Responsible Party:||Elorac, Inc.|
|Other Study ID Numbers:||
1R01FD005396-01A1 ( U.S. FDA Grant/Contract )
|First Posted:||June 23, 2016 Key Record Dates|
|Last Update Posted:||October 28, 2022|
|Last Verified:||October 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Immune System Diseases
Bacterial Infections and Mycoses
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents