Fractional CO2 Laser Assisted Photodynamic Therapy

Phase 2

Completed

• Conditions: Actinic Keratosis; Basal Cell Carcinoma
• Interventions: Drug: Conventional photodynamic therapy; Drug: Fractional CO2 laser assisted PDT

• Registration Number: NCT01260987
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-12-14
• Study First Submitted QC: 2010-12-15
• Study First Posted: 2010-12-16
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-29
• Last Update Posted: 2015-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AK split-face treatment	Conventional photodynamic therapy	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.
AK split-face treatment	Fractional CO2 laser assisted PDT	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.
Konventional PDT for BCC	Conventional photodynamic therapy	Difficult to treat nodular basal cell carcinomas in the face is treated with methyl-aminolevulinate PDT.
Fractional laser assisted PDT for BCC	Fractional CO2 laser assisted PDT	Difficult to treat nodular basal cell carcinomas in the face is pretreated with fractional CO2 laser followed by methyl-aminolevulinate PDT.

Primary Outcome Measures

Name	Time	Method
Treatment response	12 months	Blinded histological examination from patients with basal cell carcinomas
Reoccurrence	12 months	Clinical evaluation by a blinded physician

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Dermatology, Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark