E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
local anesthesia of the skin prior to minor cutaneous surgical procedures |
lokale verdoving van de huid voorafgaand aan kleine chirurgische verrichtingen van de huid |
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E.1.1.1 | Medical condition in easily understood language |
local anesthesia of the skin before small operations of the skin |
lokale verdoving van de huid vóór kleine operatie van de huid |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
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 |
The primary objective of this study is to assess the analgesic effect of fractional carbon dioxide laser assisted delivery of two topical anesthetics (articaine hydrochloride 40 mg/ml and epinephrine 10 µg/ml solution and eutectic mixture of lidocaine 25 mg/g and prilocaine 25 mg/g cream) compared to application of these anesthetics without fractional laser pretreatment. |
Het primaire doel van deze studie is een vergelijking te maken van het analgetisch effect van topicale toediening van twee topicale anesthetica (articaïne hydrochloride 40 mg/ml + epinefrine 10 µg/ml oplossing en lidocaïne 25 mg/g en prilocaïne 25 mg/g crème (EMLA-crème)) na voorbehandeling met de fractionele CO2-laser en zonder voorbehandeling met de fractionele CO2-laser. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to compare the efficacy of these two different anesthetics, when applied according to the fractional laser drug delivery principle. |
Het secundaire doel van deze studie is een vergelijking te maken tussen het analgetisch effect van deze twee lokale anesthetica, beide na voorbehandeling met de fractionele CO2-laser. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Fitzpatrick skin type I or II Age ≥18 years Patient is willing and able to give written informed consent |
Fitzpatrick-huidtype I of II Leeftijd ≥18 jaar Patiënt is bereid en bekwaam om geschreven informed consent te geven |
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E.4 | Principal exclusion criteria |
History of keloid or hypertrophic scar formation or complicated wound healing Presence of any active skin disease Known allergy to local anesthesia Pregnancy or lactation Incompetency to understand what the procedure involves Current complaints of chronic pain or other alterations in pain sensation (e.g. due to diabetes mellitus or lepra) Current treatment with systemic analgesics or other medication that can influence pain sensation Current treatment with anticoagulants Fitzpatrick skin type III-VI Excessive sun tan |
Voorgeschiedenis van keloïden/hypertrofische littekens of gecompliceerde wondgenezing Aanwezigheid van enige actieve huidziekte Bekende allergie voor lokale anesthetica Zwangerschap/lactatie Onvermogen om de implicaties van de procedure te begrijpen Klachten van chronische pijn of andere veranderingen in de pijnsensatie (bijvoorbeeld bij diabetes mellitus of lepra) Lopende therapie met systemische analgetica of andere medicatie die de pijnsensatie kan beïnvloeden. Lopende behandeling met anticoagulantia Fitzpatrick-huidtype III-VI Excessief zongebruinde huid |
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E.5 End points |
E.5.1 | Primary end point(s) |
The main study parameter is pain, as scored on a VAS from 0-10 (0: no pain; 10: worst imaginable pain) directly after each pain stimulus. |
De primaire uitkomstmaat is pijn gescoord door de patiënt op een visueel-analoge schaal van 0 tot 10, direct na iedere pijnprikkel. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Directly after the pain stimulus. Ten minutes after fractional laser pretreatment. |
Direct na de pijnprikkel. Tien minuten na voorbehandeling met de fractionele laser. |
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E.5.2 | Secondary end point(s) |
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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 | Yes |
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 | 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 |
intra subject |
within subject |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
geen voorbehandeling met fractionele laser; sham laser |
no fractional laser pretreatment; sham laser |
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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
| 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 | |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |