NCT03013647

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

7 months

First QC Date

November 28, 2016

Last Update Submit

January 5, 2017

Conditions

Actinic Keratosis

Keywords

actinic keratosisfield cancerizationphotodynamic therapydaylight photodynamic therapy

Outcome Measures

Primary Outcomes (1)

  • Clinical improvement

    Counting of Actinic keratosis

    3 months after treatment

Secondary Outcomes (2)

  • Histological changes

    3 months after treatment

  • immunochemistry changes

    3 months after treatment

Study Arms (1)

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.

Drug: Methyl Aminolevulinate

Interventions

Methyl AminolevulinateDRUG

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

Also known as: Metvix
Actinic Keratosis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clinicas

São Paulo, São Paulo, Brazil

RECRUITING

Related 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. 2017 Feb 1;27(1):89-91. doi: 10.1684/ejd.2016.2882. No abstract available.

    PMID: 27748261BACKGROUND

  • 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.

    PMID: 27061814BACKGROUND

  • 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.

    PMID: 26552049BACKGROUND

  • 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.

    PMID: 26541910BACKGROUND

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

methyl 5-aminolevulinate

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Cyro Festa, md

    Hospital das Clinicas da USP

    STUDY CHAIR

Central Study Contacts

Beni Grinblat, md

CONTACT

551138827070bgrinblat@gmail.com

Luis Torezan, md

CONTACT

torezanluis@uol.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 28, 2016

First Posted

January 6, 2017

Study Start

September 1, 2016

Primary Completion

April 1, 2017

Study Completion

July 1, 2017

Last Updated

January 6, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will share

Locations

BR(1)