Fractional CO2 Laser Assisted Photodynamic Therapy - Full Text View

Purpose

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.

Condition	Intervention	Phase
Actinic Keratosis Basal Cell Carcinoma	Drug: Conventional photodynamic therapy Drug: Fractional CO2 laser assisted PDT	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Conventional Versus Fractional CO2 Laser Assisted Photodynamic Therapy for Basal Call Carcinomas and Actinic Keratoses

Resource links provided by NLM:

Drug Information available for: Aminolevulinic acid Carbon dioxide Aminolevulinic acid hydrochloride Methyl aminolevulinate

U.S. FDA Resources

Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	47
Study Start Date:	October 2010
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260987

Contacts

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

Locations

Denmark
Department of Dermatology, Bispebjerg Hospital	Recruiting
Copenhagen, Denmark, DK-2400
Contact: Christina S Haak, MD +45 35316003 christinahaak@dadlnet.dk
Contact: Katrine Togsverd-Bo, MD +45 35316098 KTOG0001@bbh.regionh.dk
Sub-Investigator: Christina S Haak, MD
Sub-Investigator: Katrine Togsverd-Bo, MD
Principal Investigator: Merete Hædersdal, Phd,DrMedSci

Sponsors and Collaborators

Bispebjerg Hospital

Investigators

Principal Investigator:

Merete Hædersdal, PhD,DrMedSci

Bispebjerg Hospital

More Information

No publications provided

Responsible Party:	Merete Hædersdal, MD, PhD, DrMedSci, Bispebjerg Hospital
ClinicalTrials.gov Identifier:	NCT01260987 History of Changes
Other Study ID Numbers:	H-1-2010-044, 2010-020179-22
Study First Received:	December 14, 2010
Last Updated:	June 21, 2011
Health Authority:	Denmark: Ethics Committee

Keywords provided by Bispebjerg Hospital:

Moderate to severe actinic keratoses
Difficult to treat nodular basal cell carcinomas

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Basal Cell
Keratosis
Keratosis, Actinic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Skin Diseases

Precancerous Conditions
Aminolevulinic Acid
Methyl 5-aminolevulinate
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013