Bleomycin Jet Injections in Keloids
Keloid
About this trial
This is an interventional treatment trial for Keloid focused on measuring Keloid, Dermatology, Bleomycin, Jet-injection
Eligibility Criteria
Inclusion Criteria:
- Subject has provided written informed consent;
- Subject is ≥ 18 years of age at time of screening;
- 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.
- Subject is willing to fill in questionnaires and take photos using an e-diary application on their phone.
Exclusion Criteria:
- Known hypersensitivity to any component of the test materials;
- Pregnant or breast-feeding women (pregnancy test prior to treatment);
- Previous bleomycin treatment of the keloid within the last 12 weeks prior to screening.
- Non-response to previous bleomycin treatments of the keloid.
- 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.
Sites / Locations
- Eramsus Medical Centre, Dermatology department
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Bleomycin jet-injections
Placebo jet-injections
This study consists of a split-lesion design in which the keloid scar will receive three consecutive treatments with an interval of 4 weeks of: 1) bleomycin and 2) placebo (NaCl 0,9%), administered with an electronic pneumatic jet injector. A single injection of 100 μL will be given per 1 cm2, with a maximum of 20 injections per treatment. The maximum dosage of bleomycin per treatment will be 2 mL, corresponding to 2 USP-E (units) of bleomycin. The maximum cumulative dosage of bleomycin will be 6 USP-E in this study.
This study consists of a split-lesion design in which the keloid scar will receive three consecutive treatments with an interval of 4 weeks of: 1) bleomycin and 2) placebo (NaCl 0,9%), administered with an electronic pneumatic jet injector. A single injection of 100 μL will be given per 1 cm2, with a maximum of 20 injections per treatment. The maximum dosage of normal saline per treatment will be 2 mL.