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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
14
Intralesional bleomycin treatment administered with an electronic pneumatic jet injector
Intralesional placebo treatment of normal saline administered with an electronic pneumatic jet injector
Eramsus Medical Centre, Dermatology department
Rotterdam, South Holland, Netherlands
Volume reduction
Volume reduction of scar tissue in mm\^3.
Time frame: 12 weeks
Clinical efficacy using Patient and Observer Scar Assessment Scale (POSAS)
Evaluation of clinical efficacy using Patient and Observer Scar Assessment Scale. The POSAS consists of six items (vascularization, pigmentation, thickness, relief, pliability and surface). Each item will be scored on a scale from 1 (normal skin) to 10 (worst scar). The scores of these six items result in the 'POSAS total score', also on a scale from 1 (normal skin) to 10 (worst scar).
Time frame: 12 weeks
Vascular perfusion
Evaluation of changes in keloid vascular perfusion using Laser Speckle Contrast Imaging.
Time frame: 12 weeks
Residue formation on skin
Evaluation of the average residue formation on skin in percentage of the injection volume.
Time frame: 30 minutes
Procedure related pain
Evaluation of the procedure related pain using a numerical rating scale (NRS) score. This scale ranges from 0-10 points, with higher scores indicating greater pain intensity.
Time frame: 30 minutes
Local skin reactions
Evaluation of the local skin reactions using self-taken photos in an e-diary.
Time frame: 12 weeks
Treatment satisfaction
Evaluation of treatment satisfaction using a 5-point Likert scale. This scale ranges from -2 to 2 points, with higher scores indicating higher satisfaction.
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Time frame: 12 weeks
Incidence of Treatment-Emergent Adverse events [Safety and Tolerability].
Evaluation of safety and tolerability by evaluating all adverse events. Patients will daily be asked to take pictures of the treated lesion(s), and to report any adverse event via an digital e-diary application.
Time frame: 12 weeks