E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hypertrophic scars on 20 participants |
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E.1.1.1 | Medical condition in easily understood language |
Hypertrophic scars on 20 participants |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10070845 |
E.1.2 | Term | Skin scarring |
E.1.2 | System Organ Class | 100000004863 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
• 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) |
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E.2.2 | Secondary objectives of the trial |
• 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)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At treatment day and 4 weeks (+/- 7 days) at follow-up. |
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E.5.2 | 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)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Split-lesion (non treated control) |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |