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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplasms, Glandular and Epithelial
Precancerous Conditions
Skin Diseases
Aminolevulinic Acid
Methyl 5-aminolevulinate
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014