E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary histological proven superficial basal cell carcinoma ≥ 4mm < 20mm outside the H-zone of the face or scalp |
Primair histologisch bevestigd basaalcelcarcinoom ≥ 4mm en ≤ 20mm buiten de H-zone van het gelaat of behaarde hoofdhuid
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E.1.1.1 | Medical condition in easily understood language |
Superficial skincancer |
Oppervlakkige huidkanker |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042503 |
E.1.2 | Term | Superficial basal cell carcinoma |
E.1.2 | System Organ Class | 100000004864 |
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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 |
To determine whether topical sinecatechins 10% (Veregen®) ointment application can lead to a histological clearance (efficacy) of a superficial basal cell carcinoma.
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Om te bepalen of lokale toediening van sinecatechins 10% (Veregen®) zalf leidt tot een histologische clearance (effectiviteit) van een superficieel basaalcelcarcinoom.
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E.2.2 | Secondary objectives of the trial |
To assess clinical clearance, compliance and adverse reactions (safety). To assess other histological effects with additional immunohistochemic stains; Bcl-2 (anti-apoptosis), Ki67 (proliferation). |
Het bepalen van klinische clearance, compliance en bijwerkingen (veiligheid). Het bekijken van histologische effecten met aanvullende immunohistochemische kleuringen; Bcl2 (anti-apoptose) en Ki67 (proliferatie). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Adults aged 18 years or older
- Primary histological proven superficial basal cell carcinoma ≥ 4mm and ≤ 20mm
- Comorbidities may not interfere with study treatment (evaluated by investigator)
- Capable to understand instructions
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- Volwassenen ouder dan 18 jaar
- Primair histologisch bevestigd basaalcelcarcinoom ≥ 4mm en ≤ 20mm
- Comorbiditeiten mogen niet met studiemedicatie interfereren (geevalueerd door onderzoeker)
- In staat instructies te begrijpen
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E.4 | Principal exclusion criteria |
- Recurrent sBCC (previous treatment)
- Breast-feeding or pregnant women
- Serious comorbidities
- Use of immunosuppressive medication during the trial period or within 30 days before enrolment
- Patients with genetic skin cancer disorders
- Tumour located in the H zone (high-risk area of face) or scalp |
- Recidief sBCC (eerdere behandeling)
- Vrouwen die borstvoeding geven of zwanger zijn
- Ernstige comorbiditeiten
- Gebruik van immunosuppressive middelen tijden de studie periode of 30 dagen voor start van de studie
- Patiënten met genetische huidmaligniteiten syndromen
- Tumor gelokaliseerd in de H-zone (hoog-risico zone van het gezicht) of behaarde hoofdhuid |
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E.5 End points |
E.5.1 | Primary end point(s) |
The main study parameter is histological clearance of the target tumour (efficacy). This will be analysed by comparing the proportion of patients with complete histological clearance in the treatment group to placebo group assessed by two independent blinded dermato-pathologists. |
De primaire uitkomstmaat is histologische clearance van de target tumor (effectiviteit). Dit wordt onderzocht door de proportie complete histologische clearance in de behandelgroep te vergelijken met een placebogroep door twee onafhankelijke geblindeerde dermato-pathologen. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the end of the trial after surgical excision. |
Aan het einde van de studie na chirurgische excisie. |
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E.5.2 | Secondary end point(s) |
Compliance, number of local skin reactions, adverse events and serious adverse events and histological effects (immunohistochemical stains Ki67 and Bcl-2) of treatment with sinecatechins 10% ointment versus placebo. |
Compliance, het aantal lokale huidreacties en andere bijwerkingen en histologische effecten (immunohistochemische kleuringen Ki67 en Bcl-2) van de behandeling met sinecatechins 10% ointment in vergelijking met placebo. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Complicance at 6 weeks in patient diary and weight tubes.
Lokal skin reactions in subjective patient diary and objective at control visit after 3, 6 and 8 weeks.
Histological effects after surgical excision in week 8. |
Compliance in week 6 door middel van patiënten dagboek en gewicht van de tubes.
Lokale huidreacties subjectief door middel van patiënten dagboek en objectief tijdens controle visite in week 3, 6 en 8.
Histologische effecten na chirurgische excision in week 8.
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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 | Yes |
E.6.13.1 | Other scope of the trial description |
Adverse events |
Bijwerkingen |
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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) | No |
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 | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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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The end of the trial will be the last visit of the last subject undergoing the trial. |
Het einde van de studie is als het laatste bezoek van de laatste proefpersoon die meedoet aan de studie heeft plaatsgevonden. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |