Fractional CO2 Laser Assisted Photodynamic Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Bispebjerg Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01260987
First received: December 14, 2010
Last updated: June 21, 2011
Last verified: June 2011

December 14, 2010
June 21, 2011
October 2010
August 2012   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01260987 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Fractional CO2 Laser Assisted Photodynamic Therapy
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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Actinic Keratosis
  • Basal Cell Carcinoma
  • 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: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
47
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Christina S Haak, MD +45 35316003 christinahaak@dadlnet.dk
Contact: Katrine Togsverd-Bo, MD +45 35316098 KTOG0001@regionh.bbh.dk
Denmark
 
NCT01260987
H-1-2010-044, 2010-020179-22
Yes
Merete Hædersdal, MD, PhD, DrMedSci, Bispebjerg Hospital
Bispebjerg Hospital
Not Provided
Principal Investigator: Merete Hædersdal, PhD,DrMedSci Bispebjerg Hospital
Bispebjerg Hospital
June 2011

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