Clinical trial NCT03013647: Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization
Official title: Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization - Clinical and Histopathological Analysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Actinic Keratosis
Keywords: actinic keratosis
field cancerization
photodynamic therapy
daylight photodynamic therapy
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

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.

Eligibility criteria: Inclusion Criteria:

-multiple (at least five) actinic keratosis on the face, grades I and II

Exclusion Criteria:

* phototypes IV, V and VI
* patients treated for actinic keratosis up to 6 months before
* history of allergy to methyl aminolevulinate
* history of photoallergy
* pregnancy

Primary outcomes:
measure: Clinical improvement
timeFrame: 3 months after treatment
Secondary outcomes:
measure: Histological changes
timeFrame: 3 months after treatment
measure: immunochemistry changes
timeFrame: 3 months after treatment
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas
state: SP
Study officials:
affiliation: Hospital das Clinicas da USP
name: Cyro Festa, md
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.