- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05106192
Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amy Johnson, MD
- Phone Number: 216-286-7369
- Email: Amy.Johnson@UHhospitals.org
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- > 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:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cutaneous T-cell lymphomas (CTCL) Participants
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. |
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
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 can be applied up to four times daily according to patient tolerance directly to lesions.
The gel is 1% bexarotene concentration.
Nitrogen mustard is applied once daily as patient tolerates.
It is sold in a concentration of 0.016% gel.
|
Experimental: Cutaneous B-cell lymphomas (CBCL) Participants
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. |
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
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).
A standard sterile disposable 1 ml syringe and 30-gauge needle will be used to inject TAC.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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1.5 Hour after the treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participants Preference
Time Frame: 3 Months
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Number of participants that prefer traditional treatment versus MedJet.
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3 Months
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Tolerability of Pruritus
Time Frame: At Baseline, 1 month, 2 months, and 3 months
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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.
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At Baseline, 1 month, 2 months, and 3 months
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Quality of life due to skin conditions
Time Frame: 3 Months
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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. |
3 Months
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CAILS assessment of clinical efficacy
Time Frame: At Baseline, 1 month, 2 months, and 3 months
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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.
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At Baseline, 1 month, 2 months, and 3 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kevin Cooper, MD, Case Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Bacterial Infections and Mycoses
- Lymphoma, T-Cell
- Lymphoma
- Lymphoma, Follicular
- Mycoses
- Lymphoma, T-Cell, Cutaneous
- Mycosis Fungoides
- Lymphoma, Large-Cell, Anaplastic
- Lymphomatoid Papulosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
- Bexarotene
- Mechlorethamine
- Nitrogen Mustard Compounds
Other Study ID Numbers
- CASE4621
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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