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Twenty patients with multiple actinic keratosis on the face will be enrolled in the study and will be treated with Daylight Photodynamic therapy.
Before and after skin biopsies will be performed, for histological and immunohistochemical analysis.
Twenty patients with multiple thin actinic keratosis (AK) on the face will be included in the study. They will be informed of the procedure in detail and sign a consent form.
Digital photographs will be done in a standardized way. Prior to treatment, all patients will undergo 2 skin biopsies under local anesthesia and with a 2 mm punch biopsy. One biopsy will be done over an AK lesion and the other in an area with no apparent AK (field cancerization).
The patients will be treated with Daylight Photodynamic Therapy, following these steps:
Three months after treatment, two new skin biopsies will be collected, 1cm away from the initial biopsies. On the same date, new photographs will be made following the same standards as pre-treatment photographs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Actinic Keratosis | Other | Twenty patients with multiple thin AK on the face will be treated with Daylight Photodynamic Therapy with methyl aminolevulinate Skin biopsies before and after treatment will be performed in an AK lesion and in a field cancerization area. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methyl Aminolevulinate | Drug | Patients will be treated with Daylight Photodynamic therapy, following these steps:
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical improvement | Counting of Actinic keratosis | 3 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Histological changes | Histopathologic analysis in skin biopsies | 3 months after treatment |
| immunochemistry changes | immunochemistry analysis in skin biopsies |
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Inclusion Criteria:
-multiple (at least five) actinic keratosis on the face, grades I and II
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beni Grinblat, md | Contact | 551138827070 | bgrinblat@gmail.com | |
| Luis Torezan, md | Contact | torezanluis@uol.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Cyro Festa, md | Hospital das Clinicas da USP | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clinicas | Recruiting | São Paulo | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27748261 | Background | Fargnoli MC, Piccioni A, Neri L, Tambone S, Pellegrini C, Peris K. Long-term efficacy and safety of daylight photodynamic therapy with methyl amninolevulinate for actinic keratosis of the face and scalp. Eur J Dermatol. 2017 Feb 1;27(1):89-91. doi: 10.1684/ejd.2016.2882. No abstract available. | |
| 27061814 | Background |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C475457 | methyl 5-aminolevulinate |
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|
| 3 months after treatment |
| Grinblat B, Galimberti G, Pantoja G, Sanclemente G, Lopez M, Alcala D, Torezan L, Kerob D, Pascual T, Chouela E. Feasibility of daylight-mediated photodynamic therapy for actinic keratosis throughout the year in Central and South America: a meteorological study. Int J Dermatol. 2016 Sep;55(9):e488-93. doi: 10.1111/ijd.13256. Epub 2016 Apr 7. |
| 26552049 | Background | Philipp-Dormston WG, Sanclemente G, Torezan L, Tretti Clementoni M, Le Pillouer-Prost A, Cartier H, Szeimies RM, Bjerring P. Daylight photodynamic therapy with MAL cream for large-scale photodamaged skin based on the concept of 'actinic field damage': recommendations of an international expert group. J Eur Acad Dermatol Venereol. 2016 Jan;30(1):8-15. doi: 10.1111/jdv.13327. Epub 2015 Nov 9. |
| 26541910 | Background | Grinblat B, Galimberti G, Chouela E, Sanclemente G, Lopez M, Alcala D, Torezan L, Pantoja G. Daylight-mediated photodynamic therapy for actinic damage in Latin America: consensus recommendations. Photodermatol Photoimmunol Photomed. 2016 Mar;32(2):81-7. doi: 10.1111/phpp.12221. Epub 2015 Dec 9. |
| D017437 |
| Skin and Connective Tissue Diseases |