Bleomycin Jet Injections in Keloids

NCT04582305 | Unknown Phase 4

• 1 other identifier: BLEO JET
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Keloid

Keywords

Keloid; Dermatology; Bleomycin; Jet-injection

Outcome Measures

Primary Outcomes (1)

• Volume reduction

  Volume reduction of scar tissue in mm\^3.

  12 weeks

Secondary Outcomes (7)

• Clinical efficacy using Patient and Observer Scar Assessment Scale (POSAS)

  12 weeks

• Vascular perfusion

  12 weeks

• Residue formation on skin

  30 minutes

• Procedure related pain

  30 minutes

• Local skin reactions

  12 weeks

Study Arms (2)

Bleomycin jet-injections

ACTIVE COMPARATOR

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.

Drug: Bleomycin

Placebo jet-injections

PLACEBO COMPARATOR

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.

Drug: Normal saline

Interventions

Bleomycin DRUG

Intralesional bleomycin treatment administered with an electronic pneumatic jet injector

Bleomycin jet-injections

Normal saline DRUG

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

Placebo jet-injections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Centre for Human Drug Research, Netherlands: collaborator

Study Sites (1)

Eramsus Medical Centre, Dermatology department

Rotterdam, South Holland, 3015 GD, Netherlands

Location

MeSH Terms

Conditions

Keloid

Interventions

Bleomycin; Saline Solution

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Martijn van Doorn, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A single center, double-blind (patient and investigator), randomized, placebo-controlled study with a split-lesion design.

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 9, 2020
• Study Start: March 18, 2022
• Primary Completion: November 18, 2022
• Study Completion: March 30, 2023
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)