Hypertrophic scars on 20 participants MedDRA version: 20.1 Level: LLT Classification code 10070845 Term: Skin scarring System Organ Class: 100000004863
Conditions
Interventions
Trade Name: Kenalog®
Pharmaceutical Form: Solution for injection
INN or Proposed INN: TRIAMCINOLONE ACETONIDE
CAS Number: 76-25-5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type:
Sponsors
Merete Hædersdal
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Blinded, on-site, clinical evaluation of mean change in HTS height following jet-injections with TAC+5-FU at baseline and 4 weeks (+/- 5 days) after intervention, by Vancouver Scar Scale height (VSSheight). • Blinded, on-site, clinical evaluation of mean change in HTS appearance following jet-injections with TAC+5-FU at baseline and 4 weeks (+/- 7 days) after intervention, by full Vancouver Scar Scale (VSStotal). • Mean change in blinded, evaluation of clinical photos by off-site, clinical experts. evaluation of clinical photos of treated scar site, at baseline and 4 weeks (+/- 7 days) after intervention, and treated vs. untreated scar sites 4 weeks (+/- 7 days) from intervention, using the Visual Analogue Scale (VAS);Secondary Objective: • Change in scar architecture and/or vascular structure using Optical Coherence Tomography (OCT) and/or Dynamic-Optical Coherence Tomography (D-OCT). • Visualization by Matrix-assisted laser desorption/ionization mass spectrometry (MALDI-MS) of TAC+5-FU and/or measurement of TAC+5-FU concentration in by High-Performance Liquid Chromatography (HPLC) on biopsies from volunteers. • Overall patient satisfaction and patient reported pain during jet-injection treatment, both evaluated on a categorical 0-10 scale, and by descriptive/binary choice of preference (where 0 represents normal skin and 10 represents worst possible outcome) ;Primary end point(s): • Clinical photos obtained in a standardized position by a high-resolution digital camera – Canon. • Optical Coherence Tomography (OCT) and/or Dynamic-Optical Coherence Tomography (D-OCT). – Michelson Diagnostics • Matrix-assisted laser desorption/ionization mass spectrometry (MALDI-MS) and/or High-Performance Liquid Chromatography (HPLC). – Thermo Fisher Scientific. • Patient questionnaire. ;Timepoint(s) of evaluation of this end point: At treatment day and 4 weeks (+/- 7 days) at follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in scar architecture and/or vascular structure using Optical Coherence Tomography (OCT) and/or Dynamic-Optical Coherence Tomography (D-OCT). • Visualization by Matrix-assisted laser desorption/ionization mass spectrometry (MALDI-MS) of TAC+5-FU and/or measurement of TAC+5-FU concentration in by High-Performance Liquid Chromatography (HPLC) on biopsies from volunteers. • Overall patient satisfaction and patient reported pain during jet-injection treatment, both evaluated on a categorical 0-10 scale, and by descriptive/binary choice of preference (where 0 represents normal skin and 10 represents worst possible outcome) ;Timepoint(s) of evaluation of this end point: Defined in 5.2 | — |
Countries
Denmark
Contacts
Public ContactDepartment of Dermatology
Bispebjerg Hospital
Outcome results
None listed