Mycosis FungoidesPhase 3NCT02811783
Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL
A Phase 3 study testing Naloxone Hydrochloride Lotion, 0.5% in people with Mycosis Fungoides and Lymphoma, T-Cell, Cutaneous, run by Elorac, Inc. at 16 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Mycosis Fungoides, Lymphoma, T-Cell, Cutaneous, Sézary Syndrome
- What is being tested?
- Naloxone Hydrochloride Lotion, 0.5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 16 sitesUnited States
- Study dates
- Jan 2017to Sep 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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).
Who cannot join
- 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.
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- 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:
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
City of Hope
Duarte, California, 91010
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
University of Minnesota
Minneapolis, Minnesota, 55455
Stanford University
Palo Alto, California, 94304
University of Washington / Seattle Cancer Care Alliance (SCCA)
Seattle, Washington, 98109
St. Louis University Dermatology
St Louis, Missouri, 63104
Washington University School of Medicine St. Louis
St Louis, Missouri, 63110
Stony Brook Dermatology
Stony Brook, New York, 11790
USSF Health Morsani Center for Advanced Healthcare
Tampa, Florida, 33612
Cleveland Clinic Indian River Hospital
Vero Beach, Florida, 32960
About this study
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
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
Read the 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. Subjects will then have the option to enter a 26 Week Open Label Treatment Period 3 during which the same procedures as Treatment Period 1 and 2 will be performed except subjects will return only at Week 13 and Week 26 and all subjects will be treated with Naloxone Lotion 0.5%.
- Being tested
- Naloxone Hydrochloride Lotion, 0.5%, Placebo Lotion
- Keywords
- Pruritus, Mycosis Fungoides, CTCL, naloxone, opiate antagonist, Sézary Syndrome
- Medical subject headings
- Mycosis Fungoides, Lymphoma, T-Cell, Cutaneous, Sezary Syndrome, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naloxone Hydrochloride Lotion, 0.5%Drug
Topical TID for 2 weeks
Placebo LotionDrug
Topical TID for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Naloxone Hydrochloride Lotion, 0.5% | Active comparator | Naloxone Hydrochloride Lotion 0.5% Receives: Drug: Naloxone Hydrochloride Lotion, 0.5% |
| Placebo Lotion | Placebo comparator | Placebo Lotion Receives: Drug: Placebo Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS) for Pruritus
Change from Baseline to Day 14 in average NRS for Pruritus for each Treatment Period
Measured: Baseline and 2 Weeks
Secondary outcomes (5)
Responder Analysis - The difference in the proportion of subjects with a meaningful clinically significant improvement at the end of the two periods.
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.
Measured: Baseline and 2 Weeks
Numeric Rating Scale for Sleep
The change from Baseline at each week of the NRS for Sleep average score for each Treatment Period.
Measured: Baseline and 1 and 2 weeks
Numeric Rating Scale for Pruritus
The change from Baseline at Week 1 of the NRS for Pruritus average score for each Treatment Period.
Measured: Baseline and 1 week
Categorical Rating Scale (CRS) for Skin Integrity
The change from Baseline at Week 2 of the CRS for Skin Integrity for each Treatment Period.
Measured: Baseline and 2 weeks
Pruritus Quality of Life Score (PQOL)
The change from Baseline in the final categorization of the PQOL at Day 14 of each Treatment Period
Measured: Baseline and Day 14 of each Treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJan 2017
- Primary completionSep 2022
- Study completionSep 2022
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mycosis FungoidesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elorac, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott B Phillips, MD, Study director, Elorac, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811783
- Sponsor's protocol ID
- EL-1007-01-01
- Other IDs
- 1R01FD005396-01A1
- Status last verified
- Oct 2022
- First submitted
- 15 Jun 2016
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.
PubMed 32632956
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02811783
- Acronym / sponsor ID
- EL-1007-01-01
- Keywords
- Pruritus, Mycosis Fungoides, CTCL, naloxone, opiate antagonist, Sézary Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Elorac, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2017 (actual)
- Primary completion
- Sep 2022 (actual)
- Study completion
- Sep 2022 (actual)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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. Subjects will then have the option to enter a 26 Week Open Label Treatment Period 3 during which the same procedures as Treatment Period 1 and 2 will be performed except subjects will return only at Week 13 and Week 26 and all subjects will be treated with Naloxone Lotion 0.5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naloxone Hydrochloride Lotion, 0.5% | Active comparator | Drug: Naloxone Hydrochloride Lotion, 0.5%Naloxone Hydrochloride Lotion 0.5% |
| Placebo Lotion | Placebo comparator | Drug: Placebo LotionPlacebo Lotion |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naloxone Hydrochloride Lotion, 0.5%Topical TID for 2 weeks | Drug | Naloxone Hydrochloride Lotion, 0.5% |
| Placebo LotionTopical TID for 2 weeks | Drug | Placebo Lotion |
Primary outcome
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
5 secondary outcomes
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
Numeric Rating Scale for Sleep
Time frame: Baseline and 1 and 2 weeks
Numeric Rating Scale for Pruritus
Time frame: Baseline and 1 week
Categorical Rating Scale (CRS) for Skin Integrity
Time frame: Baseline and 2 weeks
Pruritus Quality of Life Score (PQOL)
Time frame: Baseline and Day 14 of each Treatment period
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Derived from this study: PubMed 32632956Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott B Phillips, MD study director
Elorac, Inc.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Naloxone Hydrochloride Lotion, 0.5% in people with Mycosis Fungoides and Lymphoma, T-Cell, Cutaneous, run by Elorac, Inc. at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (NRS) for Pruritus (time frame: Baseline and 2 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02811783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.