Clinical trial · Interventional
Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System.
NCT05106192CI-TRIAL-00090915withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study closed prior to enrollment of first participant
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous T-cell Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Lymphoma, Follicular | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Lymphoma, Large-Cell, Anaplastic | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Lymphomatoid Papulosis | Lymphomatoid Papulosis | ONTOLOGY_EXACT | 0.98 |
| Mycosis Fungoides of Skin (Diagnosis) | — | UNRESOLVED | — |
| Non Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bexarotene 1% Top Gel | Drug | — | UNRESOLVED |
| Conventional syringe | Device | — | UNRESOLVED |
| Med-Jet Injector | Device | — | UNRESOLVED |
| Nitrogen Mustard | Drug | — | UNRESOLVED |
| Triamcinolone Acetonide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cutaneous T-cell lymphomas (CTCL) Participants
- description
- 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.
- interventionNames
- Device: Med-Jet Injector
- Drug: Triamcinolone Acetonide
- Drug: Bexarotene 1% Top Gel
- Drug: Nitrogen Mustard
- type
- EXPERIMENTAL
- label
- Cutaneous B-cell lymphomas (CBCL) Participants
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. \> 18 years of age 2. Diagnosed with primary cutaneous lymphoma defined by either: * A board-certified dermatologist, OR * Dermatology Nurse Practitioner, OR * Skin punch biopsy 3. 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 4. Able to give informed consent under IRB approval procedures Exclusion Criteria: 1. Known allergy or hypersensitivity to triamcinolone acetonide 2. Known allergy to topical bexarotene or topical nitrogen mustard 3. Pregnant, breastfeeding, or planning to get pregnant 4 weeks before, during, and 4 weeks after the study. 4. Inability to provide informed consent 5. Diagnosis of erythrodermic mycosis fungoides or Sezary syndrome 6. Use of topical corticosteroids to target lesions within 1 week prior to baseline visit 7. Use of radiation therapy to target lesions within 1 week prior to baseline visit
References
Publications (0)
Data not yet available
No reference posted for this study.