Research into a novel treatment for excessive scarring using needleless injection.

Intralesional bleomycin treatment of keloids using an electronic pneumatic jet injector: a double-blind randomized, placebo-controlled trial with split-lesion design - BLEO JET

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003228-18-NL

Enrollment

Registered

2021-03-10

Start date

2021-05-25

Completion date

Unknown

Last updated

2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keloids

Interventions

Trade Name: BLEO-cell ® Product Name: Bleomycine Pharmaceutical Form: Powder for solution for injection Trade Name: Natriumchloride 0,9%, solution for injection Product Name: Natriumchloride 0,9%, so

Eligibility

Sex/Gender

All

Inclusion criteria

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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
Main Objective: To explore the volume reduction of keloid tissue after three consecutive treatments with electronic jet injector assisted bleomycin delivery, compared with placebo in a split-lesion design.;Secondary Objective: - To evaluate clinical efficacy by an investigator blinded to treatment using Patient and Observer Scar Assessment Scale (POSAS) - To evaluate changes in 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;Primary end point(s): Change in volume of keloid tissue expressed in mm3 measured at 4 weeks after three consecutive bleomycin administrations with a 4-week interval. ;Timepoint(s) of evaluation of this end point: Evaluation after 12 weeks of treatment	—

Measure

Time frame

Main Objective: To explore the volume reduction of keloid tissue after three consecutive treatments with electronic jet injector assisted bleomycin delivery, compared with placebo in a split-lesion design.;Secondary Objective: - To evaluate clinical efficacy by an investigator blinded to treatment using Patient and Observer Scar Assessment Scale (POSAS) - To evaluate changes in 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;Primary end point(s): Change in volume of keloid tissue expressed in mm3 measured at 4 weeks after three consecutive bleomycin administrations with a 4-week interval. ;Timepoint(s) of evaluation of this end point: Evaluation after 12 weeks of treatment

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Secondary

Measure	Time frame
Secondary end point(s): - 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;Timepoint(s) of evaluation of this end point: Evaluation after 12 weeks of treatment	—

Measure

Time frame

Secondary end point(s): - 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;Timepoint(s) of evaluation of this end point: Evaluation after 12 weeks of treatment

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Countries

Netherlands

Contacts

Public ContactDepartment of Dermatology

Erasmus MC

l.bik@erasmusmc.nl010 704 0704

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026