Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization

Actinic Keratosis Clinical Trial

Official title:

Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization - Clinical and Histopathological Analysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03013647
• Other study ID #: 1.788.362
• Status: Recruiting
• Phase: N/A
• First received: November 28, 2016
• Last updated: January 5, 2017
• Start date: September 2016
• Est. completion date: July 2017

Study information

• Verified date: January 2017
• Source: University of Sao Paulo General Hospital
• Contact: Beni Grinblat, md
• Phone: 551138827070
• Email: bgrinblat[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Methyl Aminolevulinate
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

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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. 2016 Oct 17. [Epub ahead of print] — View 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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical improvement	Counting of Actinic keratosis	3 months after treatment	No
Secondary	Histological changes	Histopathologic analysis in skin biopsies	3 months after treatment	No
Secondary	immunochemistry changes	immunochemistry analysis in skin biopsies	3 months after treatment	No