A Phase 4 interventional study of Bleomycin and Saline Solution in SCAR, sponsored by Clinica Dermatologica Arbache ltda. Status unknown at 1 site in Brazil. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-08-06.
Sponsored by Clinica Dermatologica Arbache ltda · Phase 4, Interventional, and Treatment
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.
Exclusion Criteria:
Bleomycin Infusion By Tattoo Machine
Drug: Bleomycin · Other: Saline Solution
Saline Infusion by Tattoo Machine
Drug: Bleomycin · Other: Saline Solution
Skin bleomycin infusion through tattoo machine
Saline solution infusion through tattoo machine
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
Time frame: Measured at baseline and up to four months after treatment
Treatment-Emergent Adverse Events of bleomycin infusion into the skin
Treatment-Emergent Adverse Events assessment through clinical follow-up and photographic documentation
Time frame: 11 monts
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Clinica Dermatologica Arbache ltda