Actinic keratosis MedDRA version: 15.1 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: SOLARAZE
Pharmaceutical Form: Gel
INN or Proposed INN: DICLOFENAC SODIUM
Other descriptive name: DICLOFENAC SODIUM
Concentration unit: g gram(s)
Concentration type: range
Concentration num
Sponsors
Fundacion para la investigación biomédica del hospital Ramón y Cajal de Madrid
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): a. Complete histologic response, defined as the absence of histologic criteria of AK (normalization of the stratum corneum with no parakeratosis and normal maturation of epidermal keratinocytes with no atypical keratinocytes). b. Tolerance of treatment, evaluated a few minutes after illumination in the case of PDT and at month 3 of treatment in the case of topical 3% diclofenac. Patients will provide a general evaluation of treatment in terms of tolerance, including an evaluation of comfort, discomfort, pain, local skin reactions and other side effects. These evaluations will be scored on a visual analog scale of 0 to 10, where 0 represents well-tolerated treatment and 10 means very poorly tolerated treatment. The responses will be grouped as follows: 0 to 3, good tolerance; 4 to 7, acceptable tolerance; and 8 to 10, poor tolerance. Patients receiving PDT and topical 3% diclofenac will score each of the treatments separately in the same way as described previously. c. Security measures: every patient will be asked to write down any incidence he/she may experience during the study, including adverse effects, need to apply or take any treatments for any adverse reactions, etc. For that purpose, every patient will be given a notebook, which will be collected at the final visit of the study. d. Adverse events: i. Proportion of patients who develop local symptoms related to the treatments. ii. Proportion of patients who develop any systemic adverse reaction(s) related to the treatments. e. Proportion of patients with recurrences 12 months after finishing treatments. f. Proportion of patients who develop other non-melanoma skin cancers on the treated areas during the 12 months after finishing the treatments. g. Study of the expression of COX2 and other oncogenic, proliferative and apoptotic markers by immunohistochemistry, evaluated by two different pathologists.;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Spain
Contacts
Public ContactDR JAEN OLASOLO
Fundacion para la investigación biomédica del hospital Ramón y Cajal de Madrid
Outcome results
None listed