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Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization

Primary Purpose

Actinic Keratosis

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Methyl Aminolevulinate
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis focused on measuring actinic keratosis, field cancerization, photodynamic therapy, daylight photodynamic therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital das ClinicasRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Actinic Keratosis

Arm Description

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.

Outcomes

Primary Outcome Measures

Clinical improvement
Counting of Actinic keratosis

Secondary Outcome Measures

Histological changes
Histopathologic analysis in skin biopsies
immunochemistry changes
immunochemistry analysis in skin biopsies

Full Information

First Posted
November 28, 2016
Last Updated
January 5, 2017
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03013647
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: mild curettage of the AK lesions application of a chemical sunscreen with sun protection factor (SPF) 30 application of methyl Aminolevulinate cream (Metvix R, Galderma Laboratories) exposition to daylight, for 120 minutes 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
Keywords
actinic keratosis, field cancerization, photodynamic therapy, daylight photodynamic therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Actinic Keratosis
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Methyl Aminolevulinate
Other Intervention Name(s)
Metvix
Intervention Description
Patients will be treated with Daylight Photodynamic therapy, following these steps: mild curettage of the AK lesions application of a chemical sunscreen SPF 30 application of methyl aminolevulinate cream (Metvix R, Galderma Laboratories) exposition to daylight, for 120 minutes cleaning of the face
Primary Outcome Measure Information:
Title
Clinical improvement
Description
Counting of Actinic keratosis
Time Frame
3 months after treatment
Secondary Outcome Measure Information:
Title
Histological changes
Description
Histopathologic analysis in skin biopsies
Time Frame
3 months after treatment
Title
immunochemistry changes
Description
immunochemistry analysis in skin biopsies
Time Frame
3 months after treatment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beni Grinblat, md
Phone
551138827070
Email
bgrinblat@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Luis Torezan, md
Email
torezanluis@uol.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cyro Festa, md
Organizational Affiliation
Hospital das Clinicas da USP
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital das Clinicas
City
Sao Paulo
State/Province
SP
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beni Grinblat, md
Phone
551138827070
Email
bgrinblat@gmail.com
First Name & Middle Initial & Last Name & Degree
Luis torezan, md
Email
torezanluis@uol.com.br
First Name & Middle Initial & Last Name & Degree
Beni Grinblat, md
First Name & Middle Initial & Last Name & Degree
Luis Torezan, md

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
27748261
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.
Results Reference
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PubMed Identifier
27061814
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.
Results Reference
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PubMed Identifier
26552049
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.
Results Reference
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PubMed Identifier
26541910
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.
Results Reference
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Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization

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