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Bleomycin Jet Injections in Keloids

NCT04582305 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2022-11-09

No results posted yet for this study

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

Interventions

DRUG

Bleomycin

Intralesional bleomycin treatment administered with an electronic pneumatic jet injector

DRUG

Normal saline

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

Sponsors & Collaborators

Principal Investigators

  • Martijn van Doorn, MD, PhD · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-18
Primary Completion
2022-11-18
Completion
2023-03-30

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04582305 on ClinicalTrials.gov