Clinical effectiveness and effect on COX-2 expression of the sequential treatment of actinic keratoses (AK) with photodynamic therapy (PDT) and diclofenac 3% gel: a phase IV clinical trial

Conditions: Actinic keratosis
MedDRA version: 15.1Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2013-000110-37-ES

Lead Sponsor: Fundacion para la investigación biomédica del hospital Ramón y Cajal de Madrid

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 eligible for inclusion in the study should:
1. Be 18 years or older.
2. Give written informed consent after receiving adequate information about the design of the study, its objectives and the potential risks associated with their participation in the study.
3. Be able to understand the aim of the study and be able to visit the hospital for the different consultations and follow-up visits.
4. Have at least 5 nonhyperkeratotic AKs on the face and/or scalp
5. Female patients agrees to use
a double barrier method of contraception from the moment of signing
the informed consent until 30 days after the end of treatment period
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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

pregnancy, breastfeeding, allergy to methyl aminolevulinate, AAS, diclofenac or to any of the excipients of these topical products, immunosuppression, porphyria, hereditary diseases that predispose to skin cancer (e.g. Gorlin syndrome, xeroderma pigmentosum), photosensitive disorders, photosensitizing treatments, previous treatments for AK in the three months prior to the beginning of the study (including imiquimod, PDT or any other therapy for AK), AKs in the perioral and periocular regions and the inability to follow the instructions or to collaborate during the development of the stud

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to evaluate the effectiveness of the combination of PDT and topical 3% diclofenac gel in combination for treating AKs (using the reduction of at least 75% of the number of AKs as our primary endpoint) compared with the application of two sessions of PDT;Secondary Objective: We will also assess the impact of these treatment modalities on the expression of COX-2 and other oncogenic markers.<br>To evaluate the development of adverse events after PDT and topical 3% diclofenac gel in combination for treating AKs compared with the application of two sessions of PDT;Primary end point(s): ?significant clinical response?, defined as a more than 75% reduction in the number of initial AKs three months after finishing the treatments. This will be evaluated using visual examination and palpation by two different expert dermatologists, blinded to the administered treatments.;Timepoint(s) of evaluation of this end point: 3 months

Secondary Outcome Measures