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OpenTrials
Completed

NCT Number: NCT01260987

Fractional CO2 Laser Assisted Photodynamic Therapy

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.

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Key information

Conditions

Actinic Keratosis Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Keratosis Keratosis, Actinic Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Dermatology, Bispebjerg Hospital

Copenhagen, DK-2400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional photodynamic therapy

Drug

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

Fractional CO2 laser assisted PDT

Drug

Pretreatment with fractional CO2 laser before methyl-aminolevulinate PDT

Primary outcomes

  1. Treatment response

    Time frame: 3 months

    Clinical evaluation by a blinded physician.

  2. Reoccurrence

    Time frame: 12 months

    Clinical evaluation by a blinded physician

  3. Treatment response

    Time frame: 12 months

    Blinded histological examination from patients with basal cell carcinomas

Secondary outcomes

  1. Pain

    Time frame: during laser and PDT

    Patient score (VAS 0-10)

  2. Adverse effects

    Time frame: 12 months

    scaring, hyper- and hypopigmentation

  3. Fluorescence

    Time frame: 3 hours

    Methyl-amonolevulinate uptake

  4. Cosmetic result

    Time frame: 12 months

    4-point scale

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 16, 2010
Registry last updated
Jul 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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