Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization
NCT ID: NCT03013647
Last Updated: 2017-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2016-09-30
2017-07-31
Brief Summary
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Before and after skin biopsies will be performed, for histological and immunohistochemical analysis.
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Detailed Description
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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:
1. mild curettage of the AK lesions
2. application of a chemical sunscreen with sun protection factor (SPF) 30
3. application of methyl Aminolevulinate cream (Metvix R, Galderma Laboratories)
4. exposition to daylight, for 120 minutes
5. cleaning of the face
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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Actinic Keratosis
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.
Methyl Aminolevulinate
Patients will be treated with Daylight Photodynamic therapy, following these steps:
1. mild curettage of the AK lesions
2. application of a chemical sunscreen SPF 30
3. application of methyl aminolevulinate cream (Metvix R, Galderma Laboratories)
4. exposition to daylight, for 120 minutes
5. cleaning of the face
Interventions
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Methyl Aminolevulinate
Patients will be treated with Daylight Photodynamic therapy, following these steps:
1. mild curettage of the AK lesions
2. application of a chemical sunscreen SPF 30
3. application of methyl aminolevulinate cream (Metvix R, Galderma Laboratories)
4. exposition to daylight, for 120 minutes
5. cleaning of the face
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* patients treated for actinic keratosis up to 6 months before
* history of allergy to methyl aminolevulinate
* history of photoallergy
* pregnancy
ALL
No
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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BENI MOREINAS GRINBLAT
Principal Investigator
Principal Investigators
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Cyro Festa, md
Role: STUDY_CHAIR
Hospital das Clinicas da USP
Locations
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Hospital das Clinicas
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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1.788.362
Identifier Type: -
Identifier Source: org_study_id
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