skin cancer squamous cell carcinoma
Conditions
Interventions
6. TREATMENT OF PATIENTS
6.1 Administration and Treatment Period
Patients will be randomly assigned in a ratio of 2:1 to one of two treatment
arms:
Group A: Patients will receive detailed informatio
Sponsors
Spirig Pharma AG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria in order to be eligible for entry into the trial: 1. Out-Patients of either sex aged >= 40 years 2. Life-expectancy of 2 years at minimum 3. Solid organ-transplant recipients who received a kidney (including pancreas), liver, lung, or heart transplant 4. Patients treated for 5 years with an immunosuppressant medication 5. Severe sun damage of the skin 6. Multiple actinic keratoses (2-5 lesions) and/or multiple dysplastic naevi 7. No present squamous cell carcinoma, basal cell carcinoma or malignant melano-ma; but history of cutaneous/cutaneous invasive malignancy with restitutio ad integrum is allowed 8. Patients who are able to understand and provide written informed consent to participate in the clinical trial (signed informed consent) according to ICH-GCP
Exclusion criteria
Exclusion criteria: Patients must not be enrolled in the trial if any of the following criteria is met: 1. Non-Caucasian 2. Absence of sun damage i.e. no signs of AK 3. Multi-organ transplantation (exception: simultaneous transplantation of kidney and pancreas) 4. Evidence of systemic infection, except viral hepatitis, at the time of recruitment 5. Known or supposed systemic malignant tumour or systemic chemotherapy within the last 5 years prior to randomisation 6. Patients participating in a clinical trial within the last four weeks before trial 7. Patients treated with the antitumour/antiangiogenetic immunosuppressant sirolimus, respectively everolimus, or acitretin or any other systemic treatment for AK at the time of randomisation 8. Patients treated with a topical drug for the AK at the time of randomisation (exception: excision or kryotherapy for hyperkeratotic lesions are allowed) 9. Change of the immunosuppression-treatment less than 3 months ago or planned 10. Present or planned interferon therapy (in liver transplant patients with hepatitis B/C) 11. Female patients with childbearing potential with a positive pregnancy test, breast feeding, or female patients with childbearing potential without adequate contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 7. ASSESSMENT OF EFFICACY 7.1 Specification of the Efficacy Parameters 7.1.1 Primary efficacy parameter • Number of new clinically diagnosed actinic keratoses or squamous cell carcinomas within two years. 7.1.2 Secondary efficacy parameter • Number of patients with new actinic keratoses, squamous cell carcinomas or basal cell carcinomas within two years | — |
Secondary
| Measure | Time frame |
|---|---|
| 7.1.3 Other exploratory efficacy parameters These parameters are assessed on the whole body surface • Median time to occurrence of new squamous cell carcinomas within two years • Median time to occurrence of new squamous cell or basal cell carcinomas within two years • Median time to occurrence of new basal cell carcinomas within two years • Number of actinic keratoses after the two years period • Median time to occurrence of other new skin tumours (Keratoacanthoma, Bowen*s disease, Merkel cell carcinoma, malignant melanoma, sebaceous carcinoma) within two years • Number of patients with new warts within two years • Number of new warts within two years • Occurrence of skin infections (Herpes simplex and HPV-infection) within two years 7.2 Methods and Timing for Assessing, Recording and Analysing Efficacy Parameters 7.2.1 Dermatological examinations Within the scope of dermatological examination the following parameters will be investigated prior trial inclusion (at Screening), at time of enrolment (Day 1) and in three-monthly intervals (Months 3, 6, 9, 12, 15, 18, 21 and 24): • Skin tumours (squamous cell carcinoma, basal cell carcinoma, keratoacanthoma, Bowen*s disease, actinic keratoses, Merkel cell carcinoma, malignant melanoma, sebaceous carcinoma) • Skin infections (viral warts, Herpes simplex and HPV-infection) • General dermatological skin condition (hypertrichosis/alopecia, pruritus, seborrhoea, sebaceous gland hyperplasia, xerosis) All skin changes will be documented in trial charts and lesions associated with the primary or secondary outcome (i.e. AK, HPV-induced warts) will be additionally documented onto a documentation grid for numerical follow up. 8. ASSESSMENT OF SAFETY | — |
Countries
Netherlands
Outcome results
None listed