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Efficacy and Safety of Treatment of Actinic Keratoses With Photodynamic Therapy Between MAL Cream and ALA Gel

NCT02647151 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-01-06

No results posted yet for this study

Summary

Photodynamic therapy technique (PDT) is a conventional technique which is performed applying the product under occlusion lesions, let it incubate for 3 hours and then exposed skin to a light source, usually red.

The conclusions of efficacy, tolerance and satisfaction that today are known about PDT with MAL, but not with ALA, which is a new photosensitizer indicated for Actinic Keratoses. The pharmaceutical form of ALA is a gel, which gives a hypothetical better penetration and consequently it is more effectively.

Conditions

  • Actinic Keratosis

Interventions

DRUG

METHYLAMINOLEVULINATE HYDROCHLORIDE

This is an intrapatient randomized clinical trial. All patients participating in the trial will receive both, experimental and control treatment, randomization will be used to determine side (right or left for treatment). Three visits will be scheduled. In the first visit epidemiological data will be collected , Actinic Keratoses are counted and drawn in a transparent template and also a photograph of each side. In that first visit treatment the PDT will be also performed, the degree of fluorescence, the pain and the degree of immediate local reaction will be measured. skin after PDT. In the second visit, to be held at 2 or 3 days, the delayed local reaction degree will be assessed. And in the third visit, held a month of PDT the clinical response and patient satisfaction will be assessed.

DRUG

AMINOLEVULINIC ACID HYDROCHLORIDE

This is an intrapatient randomized clinical trial. All patients participating in the trial will receive both, experimental and control treatment, randomization will be used to determine side (right or left for treatment). Three visits will be scheduled. In the first visit epidemiological data will be collected , Actinic Keratoses are counted and drawn in a transparent template and also a photograph of each side. In that first visit treatment the PDT will be also performed, the degree of fluorescence, the pain and the degree of immediate local reaction will be measured. skin after PDT. In the second visit, to be held at 2 or 3 days, the delayed local reaction degree will be assessed. And in the third visit, held a month of PDT the clinical response and patient satisfaction will be assessed.

Sponsors & Collaborators

  • Fundación Instituto Valenciano de Oncología

    lead OTHER

Principal Investigators

  • Carlos Serra · Servicio Dermatologia FIVO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02647151 on ClinicalTrials.gov