Mycosis Fungoides of Skin (Diagnosis)NCT05106192
Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System.
A study testing Med-Jet Injector, Triamcinolone Acetonide and Bexarotene 1% Top Gel in people with Mycosis Fungoides of Skin (Diagnosis) and Cutaneous T-cell Lymphoma, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
A study to compare pain differences between using MedJet needle-free drug-delivery system with standard of care treatment for cutaneous T-cell lymphomas and cutaneous B-cell lymphomas in participants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycosis Fungoides of Skin (Diagnosis), Cutaneous T-cell Lymphoma, Non Hodgkin Lymphoma
- What is being tested?
- Med-Jet Injector, Triamcinolone Acetonide and Bexarotene 1% Top Gel
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 1 Jun 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years of age
- Diagnosed with primary cutaneous lymphoma defined by either:
- A board-certified dermatologist, OR
- Dermatology Nurse Practitioner, OR
- Skin punch biopsy
- The presence of plaque-type primary cutaneous lymphoma lesions with at least two plaques that are at least two cm² in areas of the trunk, buttocks, or extremities that are either:
Show all 10Show fewer
- Symmetrically located on contralateral body site OR
- Within the same body site but separated by ≥ 1 cm
- Both plaques must be similar in size as much as possible
- Able to give informed consent under IRB approval procedures
Who cannot join
- Known allergy or hypersensitivity to triamcinolone acetonide
- Known allergy to topical bexarotene or topical nitrogen mustard
- Pregnant, breastfeeding, or planning to get pregnant 4 weeks before, during, and 4 weeks after the study.
- Inability to provide informed consent
- Diagnosis of erythrodermic mycosis fungoides or Sezary syndrome
- Use of topical corticosteroids to target lesions within 1 week prior to baseline visit
- Use of radiation therapy to target lesions within 1 week prior to baseline visit
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
A study to compare pain differences between using MedJet needle-free drug-delivery system with standard of care treatment for cutaneous T-cell lymphomas and cutaneous B-cell lymphomas in participants.
Read the detailed description
Participants will undergo treatments on two morphologically and anatomically matched target lesions, preferably on opposing sides of the body.
The first plaque will be treated using standard of care topical bexarotene or nitrogen mustard for participants with CTCL (cutaneous T-cell lymphomas) or intralesional TAC (triamcinolone acetonide) using a syringe/needle with participants with CBCL (cutaneous B-cell lymphomas).
The second plaque will be treated using a needle-free injector system. After the treatment, the participants will be followed for another three visits over the course of 4 months to see how the treated areas responded.
In order to account for 20% dropout, 11 patients per group (a needle free and a traditional treatment group in CBCL patients and the same two groups in CTCL patients) will be recruited.
- Conditions
- Mycosis Fungoides of Skin (Diagnosis), Cutaneous T-cell Lymphoma, Non Hodgkin Lymphoma, Lymphomatoid Papulosis, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Follicular
- Being tested
- Med-Jet Injector, Triamcinolone Acetonide, Bexarotene 1% Top Gel, Nitrogen Mustard, Conventional syringe
- Medical subject headings
- Disease, Lymphoma, T-Cell, Cutaneous, Lymphoma, Non-Hodgkin, Lymphomatoid Papulosis, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Med-Jet InjectorDevice
The Med-Jet injector is a needle-free injection system that consists of a hand-held firing body/trigger, sterilized barrel, disposable luer lock syringe, disposable nozzle cap, and disposable splash guard. The Med-Jet injector is designed to deliver drugs or biologics into the intradermal, subcutaneous, or intramuscular tissues, by means of a narrow, high-velocity jet of fluid, which penetrates the surface of the skin and delivers the fluid to the target tissue
Triamcinolone AcetonideDrug
The target lesion will be wiped with alcohol and injected with 10mg/ml of TAC directed towards the dermis to create a blanching wheal that is 1 cubic centimeter (total of 0.20 ml of injected fluid).
Bexarotene 1% Top GelDrug
Bexarotene can be applied up to four times daily according to patient tolerance directly to lesions. The gel is 1% bexarotene concentration.
Nitrogen MustardDrug
Nitrogen mustard is applied once daily as patient tolerates. It is sold in a concentration of 0.016% gel.
Conventional syringeDevice
A standard sterile disposable 1 ml syringe and 30-gauge needle will be used to inject TAC.
| Study group | Role | What they receive |
|---|---|---|
| Cutaneous T-cell lymphomas (CTCL) Participants | Experimental | The first plaque will be treated using standard of care topical bexarotene or nitrogen mustard for participants with CTCL (cutaneous T-cell lymphomas)
The second plaque will be treated using a needle-free injector system.
After the treatment, the participants will be followed for another three visits over the course of 4 months to see how the treated areas responded. Receives: Device: Med-Jet Injector; Drug: Triamcinolone Acetonide; Drug: Bexarotene 1% Top Gel; Drug: Nitrogen Mustard |
| Cutaneous B-cell lymphomas (CBCL) Participants | Experimental | The first plaque will be treated using standard of care intralesional TAC (triamcinolone acetonide) using a syringe/needle with participants with CBCL (cutaneous B-cell lymphomas).
The second plaque will be treated using a needle-free injector system.
After the treatment, the participants will be followed for another three visits over the course of 4 months to see how the treated areas responded. Receives: Device: Med-Jet Injector; Drug: Triamcinolone Acetonide; Device: Conventional syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measurement between the Med-Jet and standard of care treatment.
The pain of injections with Medjet vs conventional topical therapies of bexarotene or nitrogen mustard will be measured using a visual standard analog pain scale 0 (no distress) to 10 (unbearable distress) immediately after each injection.
Measured: 1.5 Hour after the treatment
Secondary outcomes (4)
Participants Preference
Number of participants that prefer traditional treatment versus MedJet.
Measured: 3 Months
Tolerability of Pruritus
Tolerability will be measured using Pruritus score assessment in the Medjet and topical therapy cohorts using a visual standard analog itching scale 0 (no itch) to 10 (worst itch imaginable) with the affected plaques at each indicated visit.
Measured: At Baseline, 1 month, 2 months, and 3 months
Quality of life due to skin conditions
The quality of life assessment will be done using the Dermatology Life Quality Index survey (DLQI) which will include a series of topics related to the skin condition including symptoms, feelings, effects on daily life, employment or schooling, personal relationships, and treatment.
Each of the ten (10) questions are scored from 0 to 3, giving a score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). Resulting scores are as follows: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect.
Measured: 3 Months
CAILS assessment of clinical efficacy
Composite Assessment of Index Lesion Severity (CAILS) is an assessment of individual lesions by the investigator of disease severity at the time of evaluation which can be used to monitor and compare lesions over time. CAILS is a 5-criterion scale ranging from 0 (no evidence) to 8 (severe), incorporating an assessment of the size of the lesion and severity of erythema, scaling, plaque elevation, and hypo- or hyperpigmentation. When making the assessment of severity, the Investigator will score the area with most clearance (ie, have scores of 0) within the treated plaque.
Measured: At Baseline, 1 month, 2 months, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Apr 2022
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Why it stopped: Study closed prior to enrollment of first participant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycosis Fungoides of Skin (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Cooper, MD, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106192
- Sponsor's protocol ID
- CASE4621
- Status last verified
- Jun 2025
- First submitted
- 12 Oct 2021
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System.
- ClinicalTrials.gov ID
- NCT05106192
- Acronym / sponsor ID
- CASE4621
- Conditions
- Mycosis Fungoides of Skin (Diagnosis), Cutaneous T-cell Lymphoma, Non Hodgkin Lymphoma, Lymphomatoid Papulosis, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Follicular
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study closed prior to enrollment of first participant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 3 Nov 2021 (actual)
- 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.
A study to compare pain differences between using MedJet needle-free drug-delivery system with standard of care treatment for cutaneous T-cell lymphomas and cutaneous B-cell lymphomas in participants.
Detailed description
Participants will undergo treatments on two morphologically and anatomically matched target lesions, preferably on opposing sides of the body.
The first plaque will be treated using standard of care topical bexarotene or nitrogen mustard for participants with CTCL (cutaneous T-cell lymphomas) or intralesional TAC (triamcinolone acetonide) using a syringe/needle with participants with CBCL (cutaneous B-cell lymphomas).
The second plaque will be treated using a needle-free injector system. After the treatment, the participants will be followed for another three visits over the course of 4 months to see how the treated areas responded.
In order to account for 20% dropout, 11 patients per group (a needle free and a traditional treatment group in CBCL patients and the same two groups in CTCL patients) will be recruited.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cutaneous T-cell lymphomas (CTCL) Participants | Experimental | Device: Med-Jet Injector, Drug: Triamcinolone Acetonide, Drug: Bexarotene 1% Top Gel, Drug: Nitrogen MustardThe first plaque will be treated using standard of care topical bexarotene or nitrogen mustard for participants with CTCL (cutaneous T-cell lymphomas) The second plaque will be treated using a needle-free injector system. After the treatment, the participants will be followed for another three visits over the course of 4 months to see how the treated areas responded. |
| Cutaneous B-cell lymphomas (CBCL) Participants | Experimental | Device: Med-Jet Injector, Drug: Triamcinolone Acetonide, Device: Conventional syringeThe first plaque will be treated using standard of care intralesional TAC (triamcinolone acetonide) using a syringe/needle with participants with CBCL (cutaneous B-cell lymphomas). The second plaque will be treated using a needle-free injector system. After the treatment, the participants will be followed for another three visits over the course of 4 months to see how the treated areas responded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- > 18 years of age
- Diagnosed with primary cutaneous lymphoma defined by either:
- The presence of plaque-type primary cutaneous lymphoma lesions with at least two plaques that are at least two cm² in areas of the trunk, buttocks, or extremities that are either:
- Able to give informed consent under IRB approval procedures
Key exclusion criteria (7 listed)
- Known allergy or hypersensitivity to triamcinolone acetonide
- Known allergy to topical bexarotene or topical nitrogen mustard
- Pregnant, breastfeeding, or planning to get pregnant 4 weeks before, during, and 4 weeks after the study.
- Inability to provide informed consent
- Diagnosis of erythrodermic mycosis fungoides or Sezary syndrome
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 |
|---|---|---|
| Med-Jet InjectorThe Med-Jet injector is a needle-free injection system that consists of a hand-held firing body/trigger, sterilized barrel, disposable luer lock syringe, disposable nozzle cap, and disposable splash guard. The Med-Jet injector is designed to deliver drugs or biologics into the intradermal, subcutaneous, or intramuscular tissues, by means of a narrow, high-velocity jet of fluid, which penetrates the surface of the skin and delivers the fluid to the target tissue | Device | Cutaneous B-cell lymphomas (CBCL) Participants, Cutaneous T-cell lymphomas (CTCL) Participants |
| Triamcinolone AcetonideThe target lesion will be wiped with alcohol and injected with 10mg/ml of TAC directed towards the dermis to create a blanching wheal that is 1 cubic centimeter (total of 0.20 ml of injected fluid). | Drug | Cutaneous B-cell lymphomas (CBCL) Participants, Cutaneous T-cell lymphomas (CTCL) Participants |
| Bexarotene 1% Top GelBexarotene can be applied up to four times daily according to patient tolerance directly to lesions. The gel is 1% bexarotene concentration. | Drug | Cutaneous T-cell lymphomas (CTCL) Participants |
| Nitrogen MustardNitrogen mustard is applied once daily as patient tolerates. It is sold in a concentration of 0.016% gel. | Drug | Cutaneous T-cell lymphomas (CTCL) Participants |
| Conventional syringeA standard sterile disposable 1 ml syringe and 30-gauge needle will be used to inject TAC. | Device | Cutaneous B-cell lymphomas (CBCL) Participants |
Primary outcome
Pain measurement between the Med-Jet and standard of care treatment.
Time frame: 1.5 Hour after the treatment
The pain of injections with Medjet vs conventional topical therapies of bexarotene or nitrogen mustard will be measured using a visual standard analog pain scale 0 (no distress) to 10 (unbearable distress) immediately after each injection.
4 secondary outcomes
Participants Preference
Time frame: 3 Months
Tolerability of Pruritus
Time frame: At Baseline, 1 month, 2 months, and 3 months
Quality of life due to skin conditions
Time frame: 3 Months
CAILS assessment of clinical efficacy
Time frame: At Baseline, 1 month, 2 months, and 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: Yes
Related trials for Mycosis Fungoides of Skin (Diagnosis)
Not yet recruitingPhase 1/2
A Study of MDSY-1240, a STAT3 Degrader, for the Treatment of Hematologic Malignancies and Advanced Solid Tumors
Triple-Negative Breast Cancer (TNBC), Gastric Cancer (GC)
Active, not recruitingPhase 2
Ultra Low Dose Radiation Therapy in Treating Patients With Mycosis Fungoides
Localized Skin Lesion, Mycosis Fungoides
Not yet recruitingObservational study
AI in MF Diagnosis
Mycosis Fungoides of Skin (Diagnosis), Artificial Intelligence (AI) in Diagnosis
Active, not recruitingPhase 2
Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers
Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive
RecruitingPhase 2
Effectiveness of Concurrent Ultra-Low-Dose Total-Skin Electron Beam Therapy and Brentuximab Vedotin Given Quarterly Over 12 Months for Patients With Mycosis Fungoides
Mycosis Fungoides
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.
Kevin Cooper, MD principal investigator
Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Med-Jet Injector, Triamcinolone Acetonide and Bexarotene 1% Top Gel in people with Mycosis Fungoides of Skin (Diagnosis) and Cutaneous T-cell Lymphoma, run by Case Comprehensive Cancer Center at 1 site 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 10 inclusion and 7 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: withdrawn, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Pain measurement between the Med-Jet and standard of care treatment. (time frame: 1.5 Hour after the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2025.