Bleomycin Jet Injections in Keloids

Keloid Clinical Trial

Official title:

Intralesional Bleomycin Treatment of Keloids Using an Electronic Pneumatic Jet Injector: a Double-blind Randomized, Placebo-controlled Trial With Split-lesion Design

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04582305
• Other study ID #: BLEO JET
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: March 18, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: November 2022
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: March 30, 2023
• Est. primary completion date: November 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Keloid

Intervention

Drug:
• Bleomycin
Intralesional bleomycin treatment administered with an electronic pneumatic jet injector
• Normal saline
Intralesional placebo treatment of normal saline administered with an electronic pneumatic jet injector

Locations

Country	Name	City	State
Netherlands	Eramsus Medical Centre, Dermatology department	Rotterdam	Zuid-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Erasmus Medical Center	Centre for Human Drug Research, Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume reduction	Volume reduction of scar tissue in mm^3.	12 weeks
Secondary	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).	12 weeks
Secondary	Vascular perfusion	Evaluation of changes in keloid vascular perfusion using Laser Speckle Contrast Imaging.	12 weeks
Secondary	Residue formation on skin	Evaluation of the average residue formation on skin in percentage of the injection volume.	30 minutes
Secondary	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
Secondary	Local skin reactions	Evaluation of the local skin reactions using self-taken photos in an e-diary.	12 weeks
Secondary	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
Secondary	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