Fractional CO2 Laser Assisted Photodynamic Therapy

Bispebjerg Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Actinic Keratosis; Basal Cell Carcinoma

Treatments: Drug: Fractional CO2 laser assisted PDT; Drug: Conventional photodynamic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01260987

H-1-2010-044

2010-020179-22 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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47 participants in 3 patient groups

AK split-face treatment

Active Comparator group

Description:

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.

Treatment:

Drug: Fractional CO2 laser assisted PDT

Drug: Conventional photodynamic therapy

Fractional laser assisted PDT for BCC

Active Comparator group

Description:

Difficult to treat nodular basal cell carcinomas in the face is pretreated with fractional CO2 laser followed by methyl-aminolevulinate PDT.

Treatment:

Drug: Fractional CO2 laser assisted PDT

Konventional PDT for BCC

Active Comparator group

Description:

Difficult to treat nodular basal cell carcinomas in the face is treated with methyl-aminolevulinate PDT.

Treatment:

Drug: Conventional photodynamic therapy