Bleomycin Jet Injections in Keloids

• Status: Not yet recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single center, double-blind (patient and investigator), randomized, placebo-controlled study with a split-lesion design, in which selected keloids will receive three consecutive treatments of a) bleomycin and b) placebo (saline (NaCl 0,9%)), administered with an electronic pneumatic jet injector.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasmus Medical Center
• Collaborator: Centre for Human Drug Research, Netherlands
• Treatments: Bleomycin

Criteria

Inclusion Criteria:

1. Subject has provided written informed consent;

2. Subject is ≥ 18 years of age at time of screening;

3. Subject has at least one keloid scar of ≥ 4 cm in length, or two separate keloids with a length of ≥2cm, with a minimum > 1.0 cm apart in the same anatomical region.

4. Subject is willing to fill in questionnaires and take photos using an e-diary application on their phone.

Exclusion Criteria:

1. Known hypersensitivity to any component of the test materials;

2. Pregnant or breast-feeding women (pregnancy test prior to treatment);

3. Previous bleomycin treatment of the keloid within the last 12 weeks prior to screening.

4. Non-response to previous bleomycin treatments of the keloid.

5. Any medical or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.