Actinic Keratosis MedDRA version: 18.0 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Metvix
Pharmaceutical Form:
INN or Proposed INN: METHYL AMINOLEVULINATE HYDROCHLORIDE
Other descriptive name: METHYL AMINOLEVULINATE HYDROCHLORIDE
Concentration unit: mg/g milligram(s)/gr
Sponsors
Dr. Carlos Serra
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible patients may present at least 5 QA in two symmetrical areas of the face or the scalp. Can not be significant differences in the number QAs between the two treatment areas. 1. Patients older than 18 years and able to give informed consent. 2. Patients must have at least 5 QA in two symmetrical areas of the face or the scalp. 3. Patients must no use solar protection creams or other creams (retinoic, hydroxiacids, emollients, topic antibiotics) on the treatment area during the study time. 4. Patients must agree to postpone the treatment of the other actinic keratosis lesions close to the treatment area. 5. Patients must agree going to the scheduled visits where they have to complete a form with epidemiology aspects, baseline characteristics, and satisfaction with the treatment received and taking pictures of the treatment area on each visit. 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Perioral and periocular areas of the face will be discarded as treatment zones. Patients with previous treatment with photodynamic therapy in the face or the scalp for any lesion. Patients with previous treatment for actinic keratosis in the previous 3 months, patients with inmunosuppression treatment, and patients with inherited diseases which can predispose to cutaneous cancer (Gorlin syndrome, xeroderma pigmentosum. 1. Patients who have clinical evidence of inmunosuppression, unstable cardiovascular diseases, haematological, hepatic, neurological, renal or endocrine diseases. Patients with stables medical conditions like high blood pressure. diabetes mellitus, hypercholesterolemia, etc. can be included in the study. 2. Patients who suffer form any dermatological disease in the treatment zone or around it. 3. Patients who have received previous treatment with photodynamic therapy in the selected areas. 4. Patients who have alcohol or drug dependency. 5. Being currently participating in other studies 6. Patients who have received any of the following treatments in less time than indicated: - Systemic chemotherapy, in the last 6 months - Systemics retinoids, interferon, inmunomodulators or inmunosuppressors, cytotoxic agents, systemic corticoids, in the last month - PUVA, UVB, ablative lasers, dermabrasion, chemical peelings, in the last 6 months - Topic retinoids, topic 5-fluorouracil, in the last month. - Cryotherapy, surgical extirpation, curettage, topic corticoids, in the last month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare MAL with the new photosensitizer BF-200 ALA in terms of local reaction and tolerability of the QA treatment;Secondary Objective: To compare the efficacy and characteristics of the fluorescence emision between the two photosensitizers;Primary end point(s): Clinical response will be assessed with the help of the basal photograph and the transparent template. Partial Response (PR) is defined as the resolution of ?75% of the initial actinic keratosis lesions. Complete Response (CR) is defined as the resolution of 100% of the initial actinic keratosis lesions. Patients will be asked about the pain suffered in both sides just after the illumination. Pain will be quantified with an analogical scale of 10 cm. Patients will mark a point between 0 (no pain) and 10 (maximum imaginable pain) Retarded local reaction measurement: immediate local reaction to the illumination can comprehend, in different grades: erythema, inflammation and swelling. Will be quantified in a scale from 0 to 10, where 0 is normal skin, without local reaction, and 10 a maximum local reaction. Retarded local reaction defined by the presence in higher or lower grades of erythema, inflammation and swelling, scabs and pustules, will be quantified from 0 to 10 where 0 is normal skin, without local reaction, and 10 a maximum local reaction;Timepoint(s) of evaluation of this end point: Response will be assessed at day 30 after the photodynamic therapy. Pain will be assessed just after the photodynamic therapy. Retarded local reaction measurement will be assessed at day 2-3 after the photodynamic therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Fluorescence measurement: fluorescence will be studied with a Wood light lamp, immediately before the illumination and will be measured from 0 to 10, where 0 is an absolute absence of fluorescence, 5 is a limited and selective fluorescence in the actinic keratosis lesions and 10 is a fluorescence in the complete area of treatment where the photosensitizer was applied.;Timepoint(s) of evaluation of this end point: Fluorescence measurement will be assesed just before the photodynamic therapy. | — |
Countries
Spain
Contacts
Public ContactFederico Nepote
Marketing Farmacéutico & Investigación Clinica
Outcome results
None listed