actinic keratoses MedDRA version: 14.1 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: ALACARE
Product Name: 5-Amonolevulinic acid
Product Code: 5-ALA
Pharmaceutical Form: Cream
INN or Proposed INN: 5-Aminolevulinic acid
CAS Number: 106-60-5
Concentration unit: % percent
Con
Sponsors
Medizinische Universität Wien, Univ. Klinik f. Dermatologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 18 years or older Patients who had received a kidney, liver, lung or heart transplant more than 3 years prior to inclusion into the study Patients who had been treated at least 6 month prior to study entry with a stable twofold or threefold immunsupressive treatment Patients who have clinically confirmed epithelial dysplasia (actinic keratoses), equally distributed in contralateral areas on the hands or forearms Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Invasive squamous cell carcinoma or basal cell carcinoma in the treatment area Known allergy to imiquimod and aminolevulinic acid Patients who have received retinoids, interferons or investigational drugs within 4 weeks of study initiation Patients who are participating in other dermatological study Patients with instable organ function Persistent Hepatitis B or C infections Any evidence of systemic cancer Patients who have received any systemic cancer chemotherapy or radiation therapy Pregnant and lactating women Patients with other dermatological diseases (psoriasis, eczema) who might confound clinical outcome Pateitns unable to sticjk with the study protocol Severe compromised general state
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Clinical complete remission rate of actinic keratoses as calculated by clearance numbers of actinic keratoses in organ transplant recipients 4, 12, and 24 weeks after completion of treatment with imiquimod 5% cream and photodynamic therapy with 20% 5-aminolevulinic acid cream compared to baseline, ;Main Objective: To compare the efficacy of topical imiquimod 5% cream versus photodynamic therapy with 20% 5-aminolevulinic acid cream in the treatment of actinic keratoses in organ transplant recipients on the ahnds and forearms;Secondary Objective: To compare the tolerability, the patients' satisfaction, cosmetic result and the clinical response rate after treatment with topical imiquimod 5% cream versus photodynamic therapy with 20% 5-aminolevulinic acid cream of actinic keratoses in organ transplant recipients ;Timepoint(s) of evaluation of this end point: 4, 12, and 24 weeks after completion of treatment with imiquimod 5% cream and photodynamic therapy with 20% 5-aminolevulinic acid cream | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number and size of actinic keratoses 12 and 24 weeks after end of treatment, treatment-associated pain ;Timepoint(s) of evaluation of this end point: Number and size of actinic keratoses 12 and 24 weeks after end of treatment, treatment-associated pain: during treatment controls and 4 weeks after treatment cosmetic response, Global patients' satisfaction: 4,12, 24 weeks after treatment side effects during all controls | — |
Countries
Austria
Contacts
Public ContactUniv. Klinik f. Dermatologie
Medizinische Universität Wien, Univ. Klinik f. Dermatologie
Outcome results
None listed