NCT01260987

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 16, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

July 30, 2015

Status Verified

July 1, 2015

Enrollment Period

1.8 years

First QC Date

December 14, 2010

Last Update Submit

July 29, 2015

Conditions

Actinic KeratosisBasal Cell Carcinoma

Keywords

Moderate to severe actinic keratosesDifficult to treat nodular basal cell carcinomas

Outcome Measures

Primary Outcomes (3)

  • Treatment response

    Clinical evaluation by a blinded physician.

    3 months

  • Reoccurrence

    Clinical evaluation by a blinded physician

    12 months

  • Treatment response

    Blinded histological examination from patients with basal cell carcinomas

    12 months

Secondary Outcomes (4)

  • Pain

    during laser and PDT

  • Adverse effects

    12 months

  • Fluorescence

    3 hours

  • Cosmetic result

    12 months

Study Arms (3)

AK split-face treatment

ACTIVE COMPARATOR

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 therapyDrug: Fractional CO2 laser assisted PDT

Fractional laser assisted PDT for BCC

ACTIVE COMPARATOR

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

Konventional PDT for BCC

ACTIVE COMPARATOR

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

Drug: Conventional photodynamic therapy

Interventions

Conventional photodynamic therapyDRUG

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

AK split-face treatmentKonventional PDT for BCC
Fractional CO2 laser assisted PDTDRUG

Pretreatment with fractional CO2 laser before methyl-aminolevulinate PDT

AK split-face treatmentFractional laser assisted PDT for BCC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Bispebjerg Hospital

Copenhagen, DK-2400, Denmark

Location

MeSH Terms

Conditions

Keratosis, ActinicCarcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Basal Cell

Study Officials

  • Merete Hædersdal, PhD,DrMedSci

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 14, 2010

First Posted

December 16, 2010

Study Start

October 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

July 30, 2015

Record last verified: 2015-07

Locations

DK(1)