Fractional CO2 Laser Assisted Photodynamic Therapy

This study is currently recruiting participants.

Verified June 2011 by Bispebjerg Hospital

Sponsor:

Information provided by:

Bispebjerg Hospital

ClinicalTrials.gov Identifier:

NCT01260987

First received: December 14, 2010

Last updated: June 21, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 14, 2010

Last Updated Date

June 21, 2011

Start Date ^ICMJE

October 2010

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Treatment response [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Clinical evaluation by a blinded physician.
Reoccurrence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Clinical evaluation by a blinded physician
Treatment response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Blinded histological examination from patients with basal cell carcinomas

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01260987 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pain [ Time Frame: during treatment ] [ Designated as safety issue: No ]
Patient score (VAS 0-10)
Adverse effects [ Time Frame: 12 months ] [ Designated as safety issue: No ]
scaring, hyper- and hypopigmentation
Fluorescence [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
Methyl-amonolevulinate uptake
Cosmetic result [ Time Frame: 12 months ] [ Designated as safety issue: No ]
4-point scale

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Fractional CO2 Laser Assisted Photodynamic Therapy

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Actinic Keratosis
Basal Cell Carcinoma

Intervention ^ICMJE

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

Study Arm (s)

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.
Interventions:
- Drug: Conventional photodynamic therapy
- Drug: Fractional CO2 laser assisted 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.

Intervention: Drug: Fractional CO2 laser assisted PDT
Active Comparator: Konventional PDT for BCC
Difficult to treat nodular basal cell carcinomas in the face is treated with methyl-aminolevulinate PDT.

Intervention: Drug: Conventional photodynamic therapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2012

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Christina S Haak, MD	+45 35316003	christinahaak@dadlnet.dk
Contact: Katrine Togsverd-Bo, MD	+45 35316098	KTOG0001@regionh.bbh.dk

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01260987

Other Study ID Numbers ^ICMJE

H-1-2010-044, 2010-020179-22

Has Data Monitoring Committee

Yes

Responsible Party

Merete Hædersdal, MD, PhD, DrMedSci, Bispebjerg Hospital

Study Sponsor ^ICMJE

Bispebjerg Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Merete Hædersdal, PhD,DrMedSci

Bispebjerg Hospital

Information Provided By

Bispebjerg Hospital

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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