Intralesional bleomycin treatment of keloids using an electronic pneumatic jet injector: a double-blind randomized, placebo-controlled trial with split-lesion desig
- Conditions
- Excessive scarring10014982
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 14
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 a smartphone.
1. Known hypersensitivity to any component of the test materials;
2. Pregnant or breast-feeding women (beta-HCG 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The effect on volume of keloid tissue (mm3), measured by 3D-camera, over the<br /><br>12-week treatment period. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- Clinical improvement using using Patient and Observer Scar Assessment Scale<br /><br>(POSAS)<br /><br>- Reduction of vascular perfusion using laser speckle contrast imaging<br /><br>- Residue formation on the skin (% injection volume)<br /><br>- Procedure related pain (NRS) and treatment satisfaction (5-point likert scale)<br /><br>- Local skin reactions using self-reported photos in e-diary<br /><br>- Adverse events</p><br>