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

• Status: Unknown status
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación Instituto Valenciano de Oncología
• Treatments: Aminolevulinic Acid; Methyl 5-aminolevulinate

Criteria

Inclusion Criteria:

1 Patient over 18 years old and capable of giving informed consent.

2. Provide at least 5 QA in two symmetrical areas of the face or scalp.

3. Accept the abandonment of sun creams and other creams (retinoic hydroxy acids, emollients, Topical Antibiotics ) in the treatment area during the time of the study.

4. Accept that it will postpone the treatment of other actinic keratosis close to treatment area.

5. Accept to go to scheduled visits. They should answer a questionnaire about epidemiology, history and treatment satisfaction. They will accept a photo of treatment area at each visit.

Exclusion Criteria:

1. Have any dermatological disease on the treatment zone or around it.

2. Patients who have previously been treated with therapy Photodynamic in targeted areas.

3. Patients with alcohol or drug dependence.

4. Patients who are currently participating in other studies.

5. Patients who have received any of the following medications at a time less than the indicated:

• Systemic chemotherapy in the last 6 months.

• Retinoids systemic , interferon , immunomodulatory or immunosuppressive , cytotoxic including agents , corticosteroids systemic , in the last month .

• Ultraviolet A light, Ultraviolet B light, ablative laser, dermabrasion, chemical peels, in the last 6 months.

• Topical retinoids , topical 5 -fluorouracil in the last month.

• Cryotherapy , surgical excision, curettage, topical corticosteroids in the last month.