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| Name | Class |
|---|---|
| Traderm | UNKNOWN |
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This intervention, called MMP®, is a procedure whereby drugs are injected through tattoo machines.
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:
Therefore, the total will be 50 participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bleomycin | Experimental | Bleomycin Infusion By Tattoo Machine |
|
| Saline Solution | Placebo Comparator | Saline Infusion by Tattoo Machine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bleomycin | Drug | Skin bleomycin infusion through tattoo machine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Level of melanin in the achromic scars (scar repigmentation) | Investigators will use antera device to measure the level of melanin in the achromic scars and photografic documentation | Measured at baseline and up to four months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-Emergent Adverse Events of bleomycin infusion into the skin | Treatment-Emergent Adverse Events assessment through clinical follow-up and photographic documentation | 11 monts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SAMIR ARBACHE | Contact | +5512981221011 | samir@dermocentro.com.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Dermatologica Arbache Ltda | São José dos Campos | São Paulo | 12245 760 | Brazil |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D010859 | Pigmentation Disorders |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D001761 | Bleomycin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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Scars or scarring areas will be randomized. Some scars or areas of scars will be infused with Bleomycin by tattoo machine and other scars or areas of scars will be infused with saline also by tattoo machine.
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Masking will be done by throwing a coin
| Saline Solution |
| Other |
Saline solution infusion through tattoo machine |
|
| D017437 | Skin and Connective Tissue Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |