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


Phase 2/Phase 3
18 Years
N/A
Open (Enrolling)
Both
Actinic Keratosis, Basal Cell Carcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Treatment response

Outcome Description:

Clinical evaluation by a blinded physician.

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Merete Hædersdal, PhD,DrMedSci

Investigator Role:

Principal Investigator

Investigator Affiliation:

Bispebjerg Hospital

Authority:

Denmark: Ethics Committee

Study ID:

H-1-2010-044

NCT ID:

NCT01260987

Start Date:

October 2010

Completion Date:

August 2012

Related Keywords:

  • Actinic Keratosis
  • Basal Cell Carcinoma
  • Moderate to severe actinic keratoses
  • Difficult to treat nodular basal cell carcinomas
  • Carcinoma
  • Carcinoma, Basal Cell
  • Keratosis
  • Keratosis, Actinic

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