Status:
UNKNOWN
Bleomycin Infusion (MMP®) to Repigment Achromic Scars
Lead Sponsor:
Clinica Dermatologica Arbache ltda
Collaborating Sponsors:
Traderm
Conditions:
SCAR
Eligibility:
All Genders
20-60 years
Phase:
PHASE4
Brief Summary
This intervention, called MMP®, is a procedure whereby drugs are injected through tattoo machines.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04046679
Start Date
August 31 2019
End Date
August 31 2020
Last Update
August 6 2019
Active Locations (1)
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1
Clinica Dermatologica Arbache Ltda
São José dos Campos, São Paulo, Brazil, 12245 760