Fractional CO2 Laser Assisted Photodynamic Therapy

July 29, 2015 updated by: Christina Haak, Bispebjerg Hospital

Conventional Versus Fractional CO2 Laser Assisted Photodynamic Therapy for Basal Call Carcinomas and Actinic Keratoses

Nodular Basal Cell Carcinomas:

Compare the efficacy and safety of conventional versus fractional laser assisted PDT for difficult to treat nodular cell carcinomas in the face.

Actinic keratosis:

Compare the efficacy and safety of conventional versus fractional laser assisted PDT for moderate to severe actinic keratoses located in the face and on the hands.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, DK-2400
        • Department of Dermatology, Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 or older
  • Skin type I-III
  • Fertile women using secure birth control
  • Moderate to severe actinic keratoses in the face or on the hands,
  • Difficult to treat nodular basal cell carcinomas in the face

Exclusion Criteria:

  • Pregnancy or breast feeding patients
  • Patients with porphyria
  • Patients with Gorlins syndrome
  • Patients with a tendency to produce hypertrophic scars or keloids
  • Patients with known allergy to Metvix
  • Patients who are not considered able to follow the treatment protocol (e.g. severely alcoholic, dementia, mentally ill etc.)
  • Patients with pigmented or morphea basal cell carcinomas
  • Know herpes simplex virus infection in treatment areas

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: AK split-face treatment
Split-face treatment of two symmetrical areas with moderate to severe actinic keratoses. One area is treated with conventional PDT the other with fractional laser assisted PDT.
Drug: Conventional photodynamic therapy
Photodynamic therapy using methyl-aminolevulinate and red light (37 J/cm2)
Drug: Fractional CO2 laser assisted PDT
Pretreatment with fractional CO2 laser before methyl-aminolevulinate PDT
ACTIVE_COMPARATOR: Fractional laser assisted PDT for BCC
Difficult to treat nodular basal cell carcinomas in the face is pretreated with fractional CO2 laser followed by methyl-aminolevulinate PDT.
Drug: Fractional CO2 laser assisted PDT
Pretreatment with fractional CO2 laser before methyl-aminolevulinate PDT
ACTIVE_COMPARATOR: Konventional PDT for BCC
Difficult to treat nodular basal cell carcinomas in the face is treated with methyl-aminolevulinate PDT.
Drug: Conventional photodynamic therapy
Photodynamic therapy using methyl-aminolevulinate and red light (37 J/cm2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment response
Time Frame: 3 months
Clinical evaluation by a blinded physician.
3 months
Reoccurrence
Time Frame: 12 months
Clinical evaluation by a blinded physician
12 months
Treatment response
Time Frame: 12 months
Blinded histological examination from patients with basal cell carcinomas
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: during laser and PDT
Patient score (VAS 0-10)
during laser and PDT
Adverse effects
Time Frame: 12 months
scaring, hyper- and hypopigmentation
12 months
Fluorescence
Time Frame: 3 hours
Methyl-amonolevulinate uptake
3 hours
Cosmetic result
Time Frame: 12 months
4-point scale
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Investigators

  • Principal Investigator: Merete Hædersdal, PhD,DrMedSci, Bispebjerg Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

December 14, 2010

First Submitted That Met QC Criteria

December 15, 2010

First Posted (ESTIMATE)

December 16, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 30, 2015

Last Update Submitted That Met QC Criteria

July 29, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1-2010-044
  • 2010-020179-22 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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