E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Excessive scar tissue |
littekengezwel |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
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 |
Keloid disease is a tumorous scar that grows outside of wound borders. It appears as a raised, discoloured lesion that gives rise to aesthetic and psychosocial complaints, itching, and pain. Adequate treatment is indicated, but because of variable results and recurrence of the keloid current therapies are suboptimal.
The Objective of the study is to find an effective and permanent treatment against keloid, by comparing current treatments on objective and subjective outcome.
We will do this by a randomized controlled intervention study consistent of 2 parts, in oreder to remain close to clinical practice;
1) for primary keloids comparing intralesional cryotherapy with excision combined with corticosteroid injections
2) for recurrent keloids comparing intralesional cryotherapy with excision combined with brachytherapy
This results in a total of 4 study arms; 2 in both parts of the study.
Primary endpoint is Patient Observer Scar Assesment Scale (POSAS) score.
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Keloïd is een pathologisch litteken dat buiten wondgrenzen doorgroeit. Hierdoor ontstaat een gekleurde zwelling die naast esthetische en psychosociale klachten ook jeukt en pijnlijk is. Adequate behandeling is geïndiceerd, huidige behandelingen zijn suboptimaal door wisselende resultaten en recidieven.
Doel van dit onderzoek is het vinden van de beste behandeling tegen keloïd, door huidige behandelingen te vergelijken op objectieve en subjectieve uitkomstmaten. Dit doen we door een gerandomiseerde interventie studie met 2 onderdelen, op basis van de klinische praktijk voor;
1) primaire keloïden wordt intralesionale cryotherapie vergeleken met excisie en aanvullende corticosteroïd injecties.
2) resistente keloïden wordt intralesionale cryotherapie vergeleken met excisie en aanvullend brachytherapie.
Hiermee ontstaan er 4 armen binnen het onderzoek, 2 in ieder onderdeel.
De primaire uitkomstmaat is de Patient Observer Scar Assesment Scale (POSAS) score.
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E.2.2 | Secondary objectives of the trial |
Secondary endpoints are volume reduction, Skindex-29, SF-36, ED-5Q, QST, histology,appearance of adverse reactions, and indication for further treatment. |
Secondaire uitkomstmaten zijn volumereductie, Skindex-29 score, SF-36 score, ED-5Q, QST, histologische veranderingen, het optreden van bijwerkingen en indicatie voor aanvullende behandeling. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Keloid patients, 18-75 yr old, full mental competence, sufficient knowledge of Dutch or English language, keloid suitable for primairy closure after excision, minimum keloid size of 1x1cm. |
keloïd patienten, 18-75 jaar oud, wilsbekwaam, goede beheersing Nederlandse of Engelse taal, keloïd geschikt voor excisie in 1 tempo, minimale grootte van het keloïd 1x1 cm.
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E.4 | Principal exclusion criteria |
Hypertrofic scars. Keloids less than 1 year existent, burn scars, pregnancy, previous radiotherapy which prohibits additional rediotherapy (only for the group of recurrent keloids), hypersensitivity for lidocaine, adrenaline, triamcinolone. Chronic use (>1 month) of systemic corticosteroids, or immunosuppressive medication (e.g. TNF alfa inhibitors). Use of systemic chemotherapy. Severe morbidity with a life expectancy of less than one year. |
Hypertrofische littekens. Keloïden minder dan 1 jaar oud, Brandwondlittekens, Zwangerschap, Eerder ontvangen maximale dosis radiotherapie (voor de groep resistente keloïden), Overgevoeligheid voor lidocaine, adrenaline, triamcinolon. Langdurig (>1maand) gebruik van systemische corticosteroiden, of immunocompressiva (bv. TNF alfa remmers). Gebruik van sytemische chemotherapeutica.
Ernstige morbiditeit met een levensverwachting van minder dan 1 jaar
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
before treatment, 2 weeks, 12 weeks, 26 weeks and 52 weeks after treatment |
Voor behandeling, 2 weken, 12 weken, 26 weken en 52 weken na behandeling. |
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E.5.2 | Secondary end point(s) |
Secondary endpoints are volume reduction, Skindex-29, SF-36, ED-5Q, QST, histology, appearance of adverse reactions and indication for further treatment. |
Secondaire uitkomstmaten zijn volumereductie, Skindex-29 score, SF-36 score, ED-5Q, QST, histologische veranderingen, het optreden van bijwerkingen en indicatie voor aanvullende behandeling. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Volume, skindex-29, SF-36, EQ-5D, adverse reactions: Before treatment, 2 weeks, 12 weeks, 26 weeks and 52 weeks after treatment
QST, indication for further treatment and Histology: before treatment en 26 weeks after treatment. |
Volume, skindex-29, SF-36, EQ-5D en optreden van bijwerkingen: Voor behandeling, 2 weken, 12 weken, 26 weken en 52 weken na behandeling.
QST, indicatie voor aanvullende behandeling en histologische veranderingen: voor behandeling en 26 weken na behandeling. |
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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) | No |
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 | Yes |
E.8.1.3 | Single blind | No |
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 | No |
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 |
Intralesionale cryotherapie en excisie met brachytherapie |
Intralesional cryotherapy and Excision with brachytherapy |
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E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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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LVLS |
Laaste controle van laatst geincludeerde patient |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |