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CompletedNCT01260987Updated Jul 30, 2015

Fractional CO2 Laser Assisted Photodynamic Therapy

A Phase 2/3 interventional study of Conventional photodynamic therapy and Fractional CO2 laser assisted PDT in Actinic Keratosis and Basal Cell Carcinoma, sponsored by Bispebjerg Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-30.

Sponsored by Bispebjerg Hospital · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Actinic Keratosis
  • Basal Cell Carcinoma

Keywords

  • Moderate to severe actinic keratoses
  • Difficult to treat nodular basal cell carcinomas
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 47 is close to the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Bispebjerg Hospital is the lead sponsor of 281 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
47 participants (actual)

Study arms

  • Active comparator
    AK split-face treatment

    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.

    Drug: Conventional photodynamic therapy · Drug: Fractional CO2 laser assisted PDT

  • Active comparator
    Fractional laser assisted PDT for BCC

    Difficult to treat nodular basal cell carcinomas in the face is pretreated with fractional CO2 laser followed by methyl-aminolevulinate PDT.

    Drug: Fractional CO2 laser assisted PDT

  • Active comparator
    Konventional PDT for BCC

    Difficult to treat nodular basal cell carcinomas in the face is treated with methyl-aminolevulinate PDT.

    Drug: Conventional photodynamic therapy

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

06

What researchers measure

Primary outcomes

  1. Treatment response

    Clinical evaluation by a blinded physician.

    Time frame: 3 months

  2. Reoccurrence

    Clinical evaluation by a blinded physician

    Time frame: 12 months

  3. Treatment response

    Blinded histological examination from patients with basal cell carcinomas

    Time frame: 12 months

Secondary outcomes

  1. Pain

    Patient score (VAS 0-10)

    Time frame: during laser and PDT

  2. Adverse effects

    scaring, hyper- and hypopigmentation

    Time frame: 12 months

  3. Fluorescence

    Methyl-amonolevulinate uptake

    Time frame: 3 hours

  4. Cosmetic result

    4-point scale

    Time frame: 12 months

07

Study locations

1 site
  • Department of Dermatology, Bispebjerg Hospital
    Copenhagen, DK-2400, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01260987
Lead sponsor
Bispebjerg Hospital
Responsible party
Christina Haak (MD, Bispebjerg Hospital) — Principal investigator
First posted
Dec 16, 2010
Start date
Oct 2010
Primary completion
Aug 2012
Completion
Aug 2012
Last update
Jul 30, 2015

Study contacts

Merete Hædersdal, PhD,DrMedSci
principal investigator · Bispebjerg Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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