Fractional CO2 Laser Assisted Photodynamic Therapy

Basal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01260987
• Other study ID #: H-1-2010-044
• Secondary ID: 2010-020179-22
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 14, 2010
• Last updated: July 29, 2015
• Start date: October 2010
• Est. completion date: August 2012

Study information

• Verified date: July 2015
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Actinic Keratosis
• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Conventional photodynamic therapy
Photodynamic therapy using methyl-aminolevulinate and red light (37 J/cm2)
• Fractional CO2 laser assisted PDT
Pretreatment with fractional CO2 laser before methyl-aminolevulinate PDT

Locations

Country	Name	City	State
Denmark	Department of Dermatology, Bispebjerg Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment response	Clinical evaluation by a blinded physician.	3 months	No
Primary	Reoccurrence	Clinical evaluation by a blinded physician	12 months	No
Primary	Treatment response	Blinded histological examination from patients with basal cell carcinomas	12 months	No
Secondary	Pain	Patient score (VAS 0-10)	during laser and PDT	No
Secondary	Adverse effects	scaring, hyper- and hypopigmentation	12 months	No
Secondary	Fluorescence	Methyl-amonolevulinate uptake	3 hours	No
Secondary	Cosmetic result	4-point scale	12 months	No