PDT vs PDT in combination with 3,75% Imiquimod in patients with actinic keratosis

Conditions: non melanoma skin cancer
MedDRA version: 17.0Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-004228-12-AT

Lead Sponsor: Medizinische Universität Wien, univ. Klinik f. Dermatologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients with clinically confirmed actinic keratosis in the face and scalp
Age 18 years or older
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

Known allergy to imiquimod and aminlevulinic acid
Patients with porphyria or taking photosensitizing drugs
Patients with severe compromised general state
Patients who are participating in another study
Patients unable to stick to the study protocol
Pregnant or lactating women

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of photodynamic therapy in combination with 3,75% imioquimod versus photodynamic monotherapy in patients with actinic keratosis;Secondary Objective: To compare the tolerability , relapse rate , patients satisfaction and cosmetic results after treatment with photodynamic monotherapy versus photodynamic therapy in combination with 3,75% imiquimod in the patients with actinic keratosis;Primary end point(s): Percentage of actinic keratosis cleared 3 months after completion of treatment in both groups;Timepoint(s) of evaluation of this end point: Clinical control after 3 and 6 months after treatment with PDT mono or PDT in combination with imiquimod

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The recurrence rate of actinic keratosis at 6 months after completion of therapy in both treatmens groups.<br>Cosmetic response and global patients satisfaction ;Timepoint(s) of evaluation of this end point: Recurrence rate 6 months after completion of therapy in both treatment groups<br>Cosmetic response and global patients satisfaction 6 moths after completions of therapy in both treatment groups