Treatment of hypertrophic scars using needle-free jet-injection of triamcinolone and 5-Fluorouracile.

Phase 1

• Conditions: Hypertrophic scars on 20 participants; MedDRA version: 20.1Level: LLTClassification code 10070845Term: Skin scarringSystem Organ Class: 100000004863; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2019-001066-15-DK
• Lead Sponsor: Merete Hædersdal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-05
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

•Healthy patients above 18 years of age.
•Patients presenting with hypertrophic scar (>4 mm in height)
•The length of scar should be estimated to minimum 3.0 cm or two separate scars with a length of >1cm, with a minimum > 1.0 cm apart in the same body region
•Non-smokers
•Fertile women with negative U-hCG and with use of safe anticontraceptive during the entire study period e.g. oral hormonal contraceptives, intrauterine devices, subdermal implantation or hormonal vaginal ring
•Written informed consent obtained from patient

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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•History of, or presenting with a keloid scar
•If the patient is pregnant or lactating
•use of topical treatment in the last 6 months and lack of willingness to refrain use during the trial as topical treatment, such as i.e. silicone potentially could interfere with the test results
•Anti coagulatory treatment such as Warfarin, Heparin and NOAK.
•Known allergy to the administered medications
•Previous medical treatments of the HTS
•Unable to follow the outlined study protocol

Study & Design

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