Fractional CO2 Laser Assisted Photodynamic Therapy

Study Overview
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Brief Summary
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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.

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

Conditions
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Actinic Keratosis, Basal Cell Carcinoma

Intervention / Treatment
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* Drug: Conventional photodynamic therapy
* Drug: Fractional CO2 laser assisted PDT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AK split-face treatment<br>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<br>* Photodynamic therapy using methyl-aminolevulinate and red light (37 J/cm2)<br>Drug: Fractional CO2 laser assisted PDT<br>* Pretreatment with fractional CO2 laser before methyl-aminolevulinate PDT<br>|
| Active Comparator: Fractional laser assisted PDT for BCC<br>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<br>* Pretreatment with fractional CO2 laser before methyl-aminolevulinate PDT<br>|
| Active Comparator: Konventional PDT for BCC<br>Difficult to treat nodular basal cell carcinomas in the face is treated with methyl-aminolevulinate PDT. | Drug: Conventional photodynamic therapy<br>* Photodynamic therapy using methyl-aminolevulinate and red light (37 J/cm2)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment response | Clinical evaluation by a blinded physician. | 3 months | 
| Reoccurrence | Clinical evaluation by a blinded physician | 12 months | 
| Treatment response | Blinded histological examination from patients with basal cell carcinomas | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Patient score (VAS 0-10) | during laser and PDT | 
| Adverse effects | scaring, hyper- and hypopigmentation | 12 months | 
| Fluorescence | Methyl-amonolevulinate uptake | 3 hours | 
| Cosmetic result | 4-point scale | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moderate to severe actinic keratoses, Difficult to treat nodular basal cell carcinomas