Bleomycin Jet Injections in Keloids

NCT ID: NCT04582305

Last Updated: 2022-11-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-18
• Study Completion Date: 2023-03-30

Brief Summary

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.

Detailed Description

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.

Conditions

Keloid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Bleomycin jet-injections

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.

Group Type: ACTIVE_COMPARATOR

Bleomycin

Intervention Type: DRUG

Intralesional bleomycin treatment administered with an electronic pneumatic jet injector

Placebo jet-injections

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.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

Intralesional placebo treatment of normal saline administered with an electronic pneumatic jet injector

Interventions

Bleomycin

Intralesional bleomycin treatment administered with an electronic pneumatic jet injector

Intervention Type: DRUG

Normal saline

Intralesional placebo treatment of normal saline administered with an electronic pneumatic jet injector

Intervention Type: DRUG

Eligibility 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 their phone.

Exclusion Criteria

1. Known hypersensitivity to any component of the test materials;

2. Pregnant or breast-feeding women (pregnancy 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre for Human Drug Research, Netherlands

OTHER

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

M.B.A. van Doorn

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martijn van Doorn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Eramsus Medical Centre, Dermatology department

Rotterdam, South Holland, Netherlands

Countries

Netherlands

Other Identifiers

BLEO JET

Identifier Type: -

Identifier Source: org_study_id