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

Trial Summary

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 evidence supports the effectiveness of the drug triamcinolone acetonide for treating cutaneous lymphoma?

Triamcinolone acetonide has shown effectiveness in treating various conditions, such as severe asthma and uveitic macular edema, with improvements in symptoms and visual acuity, respectively. While these studies do not directly address cutaneous lymphoma, they suggest the drug's potential effectiveness in managing inflammation-related conditions. ^{1 2 3 4 5}

Is needle-free triamcinolone acetonide injection generally safe for humans?

Triamcinolone acetonide injections have been used safely in many patients, but some people may experience side effects like weight gain, changes in menstrual cycles, increased blood pressure, and skin reactions. Rarely, severe allergic reactions can occur, so it's important to monitor for any unusual symptoms after treatment. ^{1 2 5 6 7}

What makes the needle-free triamcinolone acetonide injection unique for treating cutaneous lymphoma?

The needle-free triamcinolone acetonide injection is unique because it offers a non-invasive administration method, potentially reducing the risk of complications associated with traditional needle injections, such as hypersensitivity reactions or granulomatous reactions, which have been reported with other forms of triamcinolone acetonide injections. ^{1 2 3 6 7}

What is the purpose of this trial?

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.

Research Team

Kevin Cooper, MD

Principal Investigator

Case Comprehensive Cancer Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Corticosteroid injections of the nasal turbinates: past experience and precautions. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Anaphylaxis following intralesional triamcinolone acetonide (Kenacort) injection. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

Parenteral treatment of sarcoidosis with triamcinolone. [2013]

4. France 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]. [2014]

5. Singapore pubmed.ncbi.nlm.nih.gov

The use of triamcinolone acetonide in the treatment of severe intrinsic bronchial asthma. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Subtenon Triamcinolone Acetonide Injection with Topical Anesthesia in Pediatric Non-Infectious Uveitis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

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