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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


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
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