NCT04046679

Bleomycin Infusion (MMP®) to Repigment Achromic Scars

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Clinica Dermatologica Arbache ltda · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

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 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: 1. Subgroup 1 - Postoperative achromic scars. N1 = 10 participants 2. Subgroup 2 - post-laser therapy achromic scars. N2 = 10 participants 3. Subgroup 3 - achromic scars after non-laser ablative treatments. N3 = 10 participants 4. Subgroup 4 - Posttraumatic achromic scars. N4 = 10 participants 5. Subgroup 5 - achromic scars after phenol therapy. N5 = 10 participants Therefore, the total will be 50 participants.

Conditions

• SCAR

Interventions

Type	Name	Description
DRUG	Bleomycin	Skin bleomycin infusion through tattoo machine
OTHER	Saline Solution	Saline solution infusion through tattoo machine

Timeline

• Start date: 2019-08-31
• Primary completion: 2020-08-31
• Completion: 2020-08-31
• First posted: 2019-08-06
• Last updated: 2019-08-06

Locations

1 site across 1 country: Brazil