Bleomycin Jet Injections in Keloids
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
This is a single center, double-blind (patient and investigator), randomized, placebo-controlled study with a split-lesion design.All study procedures will be performed at the Department of Dermatology, Erasmus MC Medical Center in patients referred for scar treatment to our outpatient clinic.
Clinical photos will be obtained after signing the informed consent form by patient and investigator. Study visits and clinical assessments will be scheduled at baseline, 4 weeks, 8 weeks, and 12 weeks. Measurements include clinical photography, scar volume measured by 3D-camera, POSAS questionnaire, laser speckle contrast imaging to visualize keloid scar vascularization, measurement of residue formation on the skin, and a treatment related questionnaire. The keloid will be divided into two treatment areas, and randomly assigned to three consecutive treatments of: a) bleomycin and b) placebo (saline (NaCl 0,9%)), administered with an electronic pneumatic jet injector.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Bleomycin 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. |
Drug: Bleomycin
Intralesional bleomycin treatment administered with an electronic pneumatic jet injector
|
| Placebo Comparator: 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 normal saline per treatment will be 2 mL. |
Drug: Normal saline
Intralesional placebo treatment of normal saline administered with an electronic pneumatic jet injector
|
Outcome Measures
Primary Outcome Measures
- Volume reduction [12 weeks]
Volume reduction of scar tissue in mm3
Secondary Outcome Measures
- Clinical efficacy using Patient and Observer Scar Assessment Scale (POSAS) [12 weeks]
Evaluation of clinical efficacy using Patient and Observer Scar Assessment Scale (POSAS)
- Vascular perfusion [12 weeks]
Evaluation of changes in keloid vascular perfusion using Laser Speckle Contrast Imaging
- Residue formation on skin [30 minutes]
Evaluation of the average residue formation on skin in percentage of the injection volume
- Procedure related pain [30 minutes]
Evaluation of the procedure related pain using a numerical rating scale (NRS) score
- Local skin reactions [12 weeks]
Evaluation of the local skin reactions using self-taken photos in an e-diary
- Treatment satisfaction [12 weeks]
Evaluation of treatment satisfaction using a 5-point Likert scale
- Tolerability by evaluation of all adverse events [12 weeks]
Evaluation of the tolerability by evaluating all adverse events
Eligibility Criteria
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.
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Subject is willing to fill in questionnaires and take photos using an e-diary application on their phone.
Exclusion Criteria:
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Known hypersensitivity to any component of the test materials;
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Pregnant or breast-feeding women (pregnancy test prior to treatment);
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Previous bleomycin treatment of the keloid within the last 12 weeks prior to screening.
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Non-response to previous bleomycin treatments of the keloid.
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Erasmus Medical Center
- Centre for Human Drug Research, Netherlands
Investigators
- Principal Investigator: Martijn van Doorn, MD, PhD, Erasmus MC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BLEO JET