Primary objective: To explore the effect on volume of keloid tissue (mm3), measured by 3D-camera, after three consecutive treatments with electronic jet injector assisted bleomycin delivery, compared with placebo in a split-lesion design.Secondary…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The effect on volume of keloid tissue (mm3), measured by 3D-camera, over the
12-week treatment period.
Secondary outcome
- Clinical improvement using using Patient and Observer Scar Assessment Scale
(POSAS)
- Reduction of vascular perfusion using laser speckle contrast imaging
- Residue formation on the skin (% injection volume)
- Procedure related pain (NRS) and treatment satisfaction (5-point likert scale)
- Local skin reactions using self-reported photos in e-diary
- Adverse events
Background summary
The formation of keloid scars is related to a dysregulated immune response to
cutaneous wound healing and can be associated with substantial physical
deformities and psychological distress. Intralesional bleomycin treatment has
shown to be more effective in reducing keloid scars compared to corticosteroid
needle injections. However, treatment with conventional needle injections are
associated with severe procedure-related pain. In this study, we will explore
bleomycin treatment in keloids using an efficient dermal drug delivery
technique while minimizing treatment related pain; a pneumatic jet injector.
Study objective
Primary objective:
To explore the effect on volume of keloid tissue (mm3), measured by 3D-camera,
after three consecutive treatments with electronic jet injector assisted
bleomycin delivery, compared with placebo in a split-lesion design.
Secondary objectives:
- To evaluate clinical efficacy by an investigator blinded to treatment using
Patient and Observer Scar Assessment Scale (POSAS)
- To evaluate keloid vascular perfusion (laser speckle contrast imaging)
- To evaluate the average residue formation on skin (% of injection volume)
- To evaluate procedure related pain (NRS score)
- To evaluate local skin reactions (photos in e-diary)
- To evaluate treatment satisfaction (5-point Likert scale)
- To evaluate the tolerability by evaluating all adverse events
Study design
Single-centre, double-blinded (patient and investigator), randomized,
placebo-controlled study with a split-lesion design.
Intervention
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 (Enerjet).
Study burden and risks
Patients who are referred to the department of dermatology at the Erasmus MC
for treatment of keloids are asked to participate in this study. The study will
require four visits for the participants. At each visit, the following
non-invasive measurements will be performed: conventional clinical photography,
3D photography, POSAS questionnaire, laser speckle imaging, measurement of
post-procedure bleomycin residue formation on the skin, and a treatment related
questionnaire (vragenlijst: evaluatie na behandeling). In addition, patients
are asked to use a daily e-diary to evaluate pain and itch of the treated scar
(NRS), and document local skin reactions (digital photograph of the treated
area). A potential benefit for the participants could be an effective and less
painful treatment of their keloid scar. Potential risk for the participants
could be transient local skin reactions including erythema, oedema, blackening,
eschar formation, pigment changes and superficial ulceration.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-003228-18-NL |
| ClinicalTrials.gov | NCT04582305 |
| CCMO | NL74548.078.20 |