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| Name | Class |
|---|---|
| Centre for Human Drug Research, Netherlands | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bleomycin jet-injections | Active Comparator | 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. |
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| Placebo jet-injections | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bleomycin | Drug | Intralesional bleomycin treatment administered with an electronic pneumatic jet injector |
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| Measure | Description | Time Frame |
|---|---|---|
| Volume reduction | Volume reduction of scar tissue in mm^3. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martijn van Doorn, MD, PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eramsus Medical Centre, Dermatology department | Rotterdam | South Holland | 3015 GD | Netherlands |
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| ID | Term |
|---|---|
| D007627 | Keloid |
| ID | Term |
|---|---|
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002921 | Cicatrix |
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| ID | Term |
|---|---|
| D001761 | Bleomycin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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A single center, double-blind (patient and investigator), randomized, placebo-controlled study with a split-lesion design.
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| Normal saline | Drug | Intralesional placebo treatment of normal saline administered with an electronic pneumatic jet injector |
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| 12 weeks |
| Vascular perfusion | Evaluation of changes in keloid vascular perfusion using Laser Speckle Contrast Imaging. | 12 weeks |
| Residue formation on skin | Evaluation of the average residue formation on skin in percentage of the injection volume. | 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. | 30 minutes |
| Local skin reactions | Evaluation of the local skin reactions using self-taken photos in an e-diary. | 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. | 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. | 12 weeks |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |