Fractional CO2 Laser Assisted Photodynamic Therapy

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01260987

Enrollment

Registered

2010-12-16

Start date

2010-10-31

Completion date

2012-08-31

Last updated

2015-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic Keratosis, Basal Cell Carcinoma

Keywords

Moderate to severe actinic keratoses, Difficult to treat nodular basal cell carcinomas

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.

Interventions

DRUGConventional photodynamic therapy

Photodynamic therapy using methyl-aminolevulinate and red light (37 J/cm2)

DRUGFractional CO2 laser assisted PDT

Pretreatment with fractional CO2 laser before methyl-aminolevulinate PDT

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Treatment response	3 months	Clinical evaluation by a blinded physician.
Reoccurrence	12 months	Clinical evaluation by a blinded physician

Secondary

Measure	Time frame	Description
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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026