Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Pain measurement between the Med-Jet and standard of care treatment.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Med-Jet Injector (Device)
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.
干预措施: Triamcinolone Acetonide (Drug)
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.
干预措施: Bexarotene 1% Top Gel (Drug)
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.
干预措施: Nitrogen Mustard (Drug)
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.
干预措施: Med-Jet Injector (Device)
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.
干预措施: Triamcinolone Acetonide (Drug)
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.
干预措施: Conventional syringe (Device)
结局指标
主要结局
Pain measurement between the Med-Jet and standard of care treatment.
时间窗: 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.
次要结局
- Participants Preference(3 Months)
- Tolerability of Pruritus(At Baseline, 1 month, 2 months, and 3 months)
- Quality of life due to skin conditions(3 Months)
- CAILS assessment of clinical efficacy(At Baseline, 1 month, 2 months, and 3 months)