Needle-free Triamcinolone Acetonide Injection for Cutaneous Lymphoma

Overseen By Amy Johnson, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Must not be taking: Topical corticosteroids

Disqualifiers: Pregnancy, Erythrodermic mycosis fungoides, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1.5 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the pain experienced with a needle-free injector compared to regular shots for treating skin lymphomas, a type of cancer affecting the skin. The study uses Triamcinolone Acetonide, a medication that reduces swelling and discomfort in these conditions. Participants with cutaneous T-cell or B-cell lymphomas, who have at least two similar-sized plaques on their body, may be suitable candidates. The trial aims to determine if the new needle-free method can enhance the treatment experience. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve treatment experiences for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot use topical corticosteroids or have radiation therapy on target lesions within 1 week before starting the trial.

What prior data suggests that the MedJet needle-free drug-delivery system is safe for treating cutaneous lymphomas?

Research has shown that triamcinolone acetonide injections are generally safe when administered without a needle. Studies have found that this steroid medication is well-tolerated when delivered using the MedJet system. Some individuals might experience side effects like weight gain, but these are uncommon. The needle-free system has proven effective and comfortable for treating conditions like keloids, suggesting it may also be suitable for patients with skin lymphomas. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the needle-free injection of triamcinolone acetonide for cutaneous lymphomas because it offers a novel delivery method. Unlike traditional treatments that require needles, this approach uses a needle-free injector, which could reduce discomfort and anxiety for patients. Additionally, this method might provide more consistent delivery of the medication directly into the affected skin areas. This innovative technique could improve patient comfort and treatment adherence, making it a promising option for managing cutaneous lymphomas.

What evidence suggests that the Med-Jet Injector is effective for cutaneous lymphomas?

Research has shown that triamcinolone acetonide effectively treats skin conditions like cutaneous lymphomas. In this trial, participants with cutaneous B-cell lymphomas (CBCL) will receive triamcinolone acetonide injections directly into the skin using both a standard syringe and a needle-free injector system. This method has successfully shrunk lesions. Participants with cutaneous T-cell lymphomas (CTCL) will receive standard topical treatments, such as bexarotene or nitrogen mustard, along with the needle-free injector system. The needle-free system aims to make the treatment process less painful while maintaining effectiveness. ^{2 3 4 6 7}

Who Is on the Research Team?

Kevin Cooper, MD

Principal Investigator

Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

Adults diagnosed with primary cutaneous lymphoma by a dermatologist, nurse practitioner, or biopsy can join. They must have similar-sized skin plaques suitable for treatment and be able to consent. Excluded are those allergic to trial drugs, pregnant or breastfeeding women, patients with certain severe lymphomas, or recent users of corticosteroids/radiation on lesions.

Inclusion Criteria

I have skin lymphoma with two large, similar-sized patches on my body.

I am older than 18 years.

Able to give informed consent under IRB approval procedures

Exclusion Criteria

I have been diagnosed with erythrodermic mycosis fungoides or Sezary syndrome.

Known allergy to topical bexarotene or topical nitrogen mustard

Inability to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment on two target lesions using standard of care and a needle-free injector system

1.5 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Med-Jet Injector
• Triamcinolone Acetonide

Trial Overview The study is testing the pain levels when using MedJet needle-free system versus conventional syringes for delivering Triamcinolone Acetonide into skin lymphoma plaques. It also looks at how well these methods work compared to standard treatments like Bexarotene gel and Nitrogen Mustard.

How Is the Trial Designed?

Group I: Cutaneous T-cell lymphomas (CTCL) Participants Experimental Treatment 4 Interventions

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.

Group II: Cutaneous B-cell lymphomas (CBCL) Participants Experimental Treatment 3 Interventions

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.

Triamcinolone Acetonide is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Triamcinolone Acetonide for:

• Knee osteoarthritis
• Skin allergies
• Respiratory allergies

Approved in European Union as Triamcinolone Acetonide for:

• Knee osteoarthritis
• Skin allergies
• Respiratory allergies

Approved in Canada as Triamcinolone Acetonide for:

• Knee osteoarthritis
• Skin allergies
• Respiratory allergies

Approved in Japan as Triamcinolone Acetonide for:

• Knee osteoarthritis
• Skin allergies
• Respiratory allergies

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Published Research Related to This Trial

Triamcinolone acetonide (Kenalog) injections into the nasal turbinates have been successfully used in over 60,000 patients for treating allergic and vasomotor rhinitis, showing positive results without serious side effects.

The authors highlight the importance of preventing complications, such as intravascular injections that can affect the retinal circulation, by proposing specific methods to avoid this risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Corticosteroid injections of the nasal turbinates: past experience and precautions. McCleve, D., Goldstein, J., Silver, S.[2019]

In a trial involving 40 sarcoidosis patients treated with intramuscular triamcinolone acetonide (Kenacort A), the treatment showed a higher rate of improvement in chest findings compared to oral prednisolone, indicating its efficacy.

The intramuscular treatment also resulted in fewer side effects and a significant improvement in ocular lesions, suggesting it may be a safer alternative to oral corticosteroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parenteral treatment of sarcoidosis with triamcinolone. Mikami, R., Hiraga, Y., Yotsumoto, H., et al.[2013]

A 24-year-old woman experienced an immediate hypersensitivity reaction to intralesional triamcinolone acetonide after 10 years of successful treatment for keloid scars, highlighting that such reactions, while uncommon, can occur even after multiple prior injections without issues.

Allergy testing confirmed a positive reaction specifically to triamcinolone acetonide, indicating that IgE-mediated hypersensitivity should be considered in patients receiving repeated injections of this medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anaphylaxis following intralesional triamcinolone acetonide (Kenacort) injection. Laisuan, W., Wongsa, C., Dchapaphapeaktak, N., et al.[2020]

In a study involving 30 children with non-infectious uveitis, subtenon triamcinolone acetonide (STA) injections showed significant efficacy, with 85.4% of eyes experiencing inflammation improvement and 77.8% resolution of macular edema at the 3-month follow-up.

The procedure was safe, with no immediate complications reported, and only a 12.5% incidence of ocular hypertension at 6 months, indicating that STA injections are a well-tolerated treatment option for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subtenon Triamcinolone Acetonide Injection with Topical Anesthesia in Pediatric Non-Infectious Uveitis. Jung, JL., Harasawa, M., Patnaik, JL., et al.[2023]

In a study of 145 patients with severe bronchial asthma, repeated intramuscular injections of triamcinolone acetonide (Kenalog) resulted in excellent or good outcomes in 88.3% of cases, indicating its high efficacy for patients who did not respond to other treatments.

While Kenalog was effective, 13.8% of patients experienced side effects such as weight gain and increased blood pressure, highlighting the need for careful monitoring during prolonged steroid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of triamcinolone acetonide in the treatment of severe intrinsic bronchial asthma. Romański, B., Pawlik, K., Wilewska-Klubo, T.[2013]

Intralesional Kenalog (triamcinolone) is an effective treatment for skin conditions like nodulocystic acne, demonstrating its therapeutic potential.

However, this case highlights a rare but significant side effect: a granulomatous reaction, indicating that while the treatment is beneficial, it can also lead to adverse histopathological responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Granulomatous Reaction to Intralesional Kenalog (Triamcinolone) Injection in Acne: A Case Report. Song, Y., Guo, Y.[2020]

In a study of 31 eyes from 30 patients, subconjunctival injections of triamcinolone acetonide significantly improved visual acuity and reduced central macular thickness over 12 months, indicating its efficacy in treating uveitic macular edema.

The treatment was found to be safe, with no significant increase in intraocular pressure and only one cataract diagnosed, which occurred in an uninjected eye, suggesting minimal risk of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Safety and efficacy of subconjunctival triamcinolone injections in the management of uveitic macular edema: retrospective study of thirty-one cases]. Bleriot, A., Couret, C., Le Meur, G., et al.[2014]

Citations

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Needle-free Triamcinolone Acetonide Injection for ... Triamcinolone acetonide has shown effectiveness in treating various conditions, such as severe asthma and uveitic macular edema, with improvements in symptoms ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-04725

Triamcinolone Acetonide (TAC) Injections with a New ... This clinical trial tests the administration of the steroid medication, TAC, using MedJet, a new needle-free drug-delivery system in patients with primary ...

3. ctv.veeva.com ctv.veeva.com/study/triamcinolone-acetonide-injections-in-primary-cutaneous-lymphoma-plaques-with-a-novel-needle-free-dr

Triamcinolone Acetonide Injections in Primary Cutaneous ... A study to compare pain differences between using MedJet needle-free drug-delivery system with standard of care treatment for cutaneous ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8611707/

Intralesional Agents in Dermatology: Pros and Cons - PMC Intralesional (IL) agent therapy is the injection of a higher concentration of a agents directly into skin lesions without significant systemic absorption.

5. ichgcp.net ichgcp.net/clinical-trials-registry/NCT05106192

Triamcinolone Acetonide Injections in Primary Cutaneous ... A study to compare pain differences between using MedJet needle-free drug-delivery system with standard of care treatment for cutaneous T-cell ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05106192?term=AREA%5BConditionSearch%5D(Skin%20Diseases)%20AND%20AREA%5BBasicSearch%5D(Triamcinolone%20Acetonide)&rank=9

Triamcinolone Acetonide Injections in Primary Cutaneous ... Participants will undergo treatments on two morphologically and anatomically matched target lesions, preferably on opposing sides of the body.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38093082/

Needle-Free Jet Injector-Assisted Triamcinolone Treatment ... Electronic pneumatic jet injector-assisted intralesional triamcinolone acetonide is an effective and well-tolerated treatment for keloids and hypertrophic ...