Research into a novel treatment for excessive scarring using needleless injection.

Phase 1

• Conditions: Keloids; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2020-003228-18-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-10
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 15

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 a smartphone.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Known hypersensitivity to any component of the test materials;
2.Pregnant or breast-feeding women (beta-HCG 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified