NCT00843323

Brief Summary

In this study, 26 patients were selected and included for full-face photodynamic therapy sessions. All patients presented signs of photoaging skin and multiple actinic keratosis. Photographs and Biopsies were taken before and after the procedure. Clinical and histological aspects as well as immunohistochemical aspects regarding neocollagen induction and tumor expression were evaluated.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2008

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2009

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

February 12, 2009

Last Update Submit

May 8, 2023

Conditions

Actinic KeratosisPhotoagingSolar Elastosis

Interventions

Methylaminolevulinate - photodynamic therapyOTHER

Methylaminolevulinate cream 16% applied for 3 hours under occlusion on the face and then illuminated with red LED device

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with severe photodamage and at least 3 actinic keratosis on the face

You may not qualify if:

  • Pregnancy, laser, chemical peel, imiquimod or 5-Fu treatment in the last year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Luis A Torezan, MD

    Hospital das Clinicas - Faculdade de Medicina USP - Sao Paulo- Brazil

    PRINCIPAL INVESTIGATOR

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
ASSOCIATE PROFESSOR OF DERMATOLOGY

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 13, 2009

Study Start

December 1, 2008

Primary Completion

March 1, 2009

Study Completion

June 1, 2009

Last Updated

May 10, 2023

Record last verified: 2023-05