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Bleomycin Jet Injections in Keloids

Primary Purpose

Keloid

Status
Active
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Bleomycin
Normal saline
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keloid focused on measuring Keloid, Dermatology, Bleomycin, Jet-injection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eramsus Medical Centre, Dermatology department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bleomycin jet-injections

Placebo jet-injections

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Volume reduction
Volume reduction of scar tissue in mm^3.

Secondary Outcome Measures

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).
Vascular perfusion
Evaluation of changes in keloid vascular perfusion using Laser Speckle Contrast Imaging.
Residue formation on skin
Evaluation of the average residue formation on skin in percentage of the injection volume.
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.
Local skin reactions
Evaluation of the local skin reactions using self-taken photos in an e-diary.
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.
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.

Full Information

First Posted
October 5, 2020
Last Updated
November 7, 2022
Sponsor
Erasmus Medical Center
Collaborators
Centre for Human Drug Research, Netherlands
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1. Study Identification

Unique Protocol Identification Number
NCT04582305
Brief Title
Bleomycin Jet Injections in Keloids
Official Title
Intralesional Bleomycin Treatment of Keloids Using an Electronic Pneumatic Jet Injector: a Double-blind Randomized, Placebo-controlled Trial With Split-lesion Design
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 18, 2022 (Actual)
Primary Completion Date
November 18, 2022 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
Collaborators
Centre for Human Drug Research, Netherlands

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid
Keywords
Keloid, Dermatology, Bleomycin, Jet-injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
A single center, double-blind (patient and investigator), randomized, placebo-controlled study with a split-lesion design.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bleomycin jet-injections
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo jet-injections
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bleomycin
Intervention Description
Intralesional bleomycin treatment administered with an electronic pneumatic jet injector
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Intralesional placebo treatment of normal saline administered with an electronic pneumatic jet injector
Primary Outcome Measure Information:
Title
Volume reduction
Description
Volume reduction of scar tissue in mm^3.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Clinical efficacy using Patient and Observer Scar Assessment Scale (POSAS)
Description
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).
Time Frame
12 weeks
Title
Vascular perfusion
Description
Evaluation of changes in keloid vascular perfusion using Laser Speckle Contrast Imaging.
Time Frame
12 weeks
Title
Residue formation on skin
Description
Evaluation of the average residue formation on skin in percentage of the injection volume.
Time Frame
30 minutes
Title
Procedure related pain
Description
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.
Time Frame
30 minutes
Title
Local skin reactions
Description
Evaluation of the local skin reactions using self-taken photos in an e-diary.
Time Frame
12 weeks
Title
Treatment satisfaction
Description
Evaluation of treatment satisfaction using a 5-point Likert scale. This scale ranges from -2 to 2 points, with higher scores indicating higher satisfaction.
Time Frame
12 weeks
Title
Incidence of Treatment-Emergent Adverse events [Safety and Tolerability].
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has provided written informed consent; Subject is ≥ 18 years of age at time of screening; 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. Subject is willing to fill in questionnaires and take photos using an e-diary application on their phone. Exclusion Criteria: Known hypersensitivity to any component of the test materials; Pregnant or breast-feeding women (pregnancy test prior to treatment); Previous bleomycin treatment of the keloid within the last 12 weeks prior to screening. Non-response to previous bleomycin treatments of the keloid. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martijn van Doorn, MD, PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eramsus Medical Centre, Dermatology department
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 GD
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

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Bleomycin Jet Injections in Keloids

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