Bleomycin Infusion (MMP®) to Repigment Achromic Scars
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Level of melanin in the achromic scars (scar repigmentation)
研究概览
简要总结
This intervention, called MMP®, is a procedure whereby drugs are injected through tattoo machines.
详细描述
Treatment consists of Bleomycin infusion (3.0 U/ml) compared to saline infusion (parallel treatment).
Results will be evaluated after a maximum of 7 treatments, through clinical evaluation and Antera equipment analyze.
Laboratory tests are being requested to verify hematologic, renal and hepatic integrity.
The treatment will be double blind, one side of the scar will be treated with bleomycin and the other side saline infusion.
The test will consist of 5 subgroups of scars:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Masking will be done by throwing a coin
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy men and women between 20 and 60 years old.
- •Be able and willing to comply with all programming and requirements for visits, treatment and evaluation.
- •Can understand and provide written informed consent.
- •Women of childbearing age will be required to use a viable and effective method of birth control at least 3 months before and after study participation and throughout the course of the study.
- •Prior hematological, hepatic and renal laboratory evaluation proving integrity of these organs, in addition to negative pregnancy test.
- •If the participant is referred by another doctor, they should obtain a letter of authorization to participate in this trial.
排除标准
- •Bleomycin is contraindicated for patients who show hypersensitivity or idiosyncratic reaction to the referred drug
- •Patients using brentuximab or cyclophosphamide, which may result in increased risk of pulmonary toxicity
- •Patients undergoing oxygen therapy, radiotherapy, antineoplastic drug therapy.
- •Pregnancy. Fertile women should simultaneously use two contraceptive methods, for example contraceptives and condoms.
- •Breast-feeding.
- •Lung disease or history.
- •"Bone Marrow Diseases"
- •"Patients with compromised nutritional status"
- •"Patients with proven and serious blood problems"
- •"Severe infection"
- •"Patients undergoing major surgery"
- •Participants with non-randomizable scars, for example, will be excluded from the study participants with few lesions smaller than 1.0 cm. or patients with scars with complex morphology, difficult to randomize, will be excluded from the study.
- •Scars with dimensions greater than 1% of body area.
- •Patients extremely sensitive to pain or intolerant to any type of skin intervention.
- •Less than 3 months after birth or less than 6 weeks after breastfeeding has ended.
- •Decompensated comorbidity or any disease that, in the opinion of the investigator, may interfere with treatment, healing or cure.
- •Have a bleeding disorder or use anticoagulants, including aspirin (at least 10 days of anticoagulant withdrawal).
- •Sensitivity or skin fragility, favor bleeding.
- •History of immunosuppression / immune deficiency disorders (including HIV infection).
- •Any condition that, in the opinion of the investigator, is unsafe for participants, such as acute psychiatric disorders, panic syndrome or any aversion to needles or the procedure.
- •Infectious process at the application site.
- •Scars from infectious processes, e.g. herpes simplex, herpes zoster, chickenpox, cutaneous leishmaniasis, or any scarring secondary to infectious pathology.
- •Clinically thickened achromic scars.
研究组 & 干预措施
Bleomycin
Bleomycin Infusion By Tattoo Machine
干预措施: Bleomycin (Drug)
Bleomycin
Bleomycin Infusion By Tattoo Machine
干预措施: Saline Solution (Other)
Saline Solution
Saline Infusion by Tattoo Machine
干预措施: Bleomycin (Drug)
Saline Solution
Saline Infusion by Tattoo Machine
干预措施: Saline Solution (Other)
结局指标
主要结局
Level of melanin in the achromic scars (scar repigmentation)
时间窗: Measured at baseline and up to four months after treatment
Investigators will use antera device to measure the level of melanin in the achromic scars and photografic documentation
次要结局
- Treatment-Emergent Adverse Events of bleomycin infusion into the skin(11 monts)
研究者
SAMIR ARBACHE
Principal Investigator
Clinica Dermatologica Arbache ltda