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Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin

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ClinicalTrials.gov Identifier: NCT03006185
Recruitment Status : Completed
First Posted : December 30, 2016
Last Update Posted : July 13, 2017
Sponsor:
Collaborator:
Galderma R&D
Information provided by (Responsible Party):
Merete Haedersdal, Bispebjerg Hospital

Tracking Information
First Submitted Date  ICMJE December 9, 2016
First Posted Date  ICMJE December 30, 2016
Last Update Posted Date July 13, 2017
Study Start Date  ICMJE August 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 26, 2016)
Complete clearance (%) of actinic keratoses (AKs) [ Time Frame: 12-15 weeks post-treatment ]
Percentage clearance of baseline actinic keratoses (AKs), determined by the ratio of AKs that are clinically resolved 12-15 weeks after treatment compared to the AK number at baseline.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 26, 2016)
  • New actinic keratoses (AKs) [ Time Frame: 12-15 weeks post-treatment ]
    Number of new actinic keratoses (AKs) identified clinically 12-15 weeks after treatment and that were not present at the baseline evaluation.
  • Severity of local skin reactions (LSRs) [ Time Frame: up to 5 days post-treatment ]
    Local skin reactions consisting of erythema, edema, crusting, pustules, ulceration and scabbing, the severity of each evaluated clinically on a 4 point scale where 0 = none, 1= mild, 2= moderate and 3= severe.
  • Degree of sun damage [ Time Frame: 12-15 weeks post-treatment ]
    Sun damage is evaluated clinically on a 4 point scale where 0 = none, 1= mild, 2= moderate and 3= severe sun damage.
  • Treatment-related Pain [ Time Frame: during treatment (day 0) ]
    Patient-reported pain during treatments is evaluated using the visual analog scale (VAS) where 0= no pain and 10= worst imaginable pain.
  • Treatment-related Side Effects [ Time Frame: up to 12-15 weeks post-treatment ]
    Side effects are evaluated over the course 12-15 weeks following treatment. In addition to unforeseen adverse events, specific side effects including the clinical presence of infection, scarring, hypopigmentation and hyperpigmentation are recorded.
  • Investigator-reported cosmesis (clinical evaluation) [ Time Frame: 12-15 weeks post-treatment ]
    Cosmetic appearance of treated areas is evaluated by investigators clinically on a 4 point scale where 0 = none, 1= acceptable, 2= good and 3= excellent outcome.
  • Patient-reported Cosmesis [ Time Frame: 12-15 weeks post-treatment ]
    Cosmetic appearance is evaluated by patients at the end of the study on a 4 point scale where 0 = none, 1= acceptable, 2= good and 3= excellent
  • Patient Pretreatment Preference [ Time Frame: 12-15 weeks post-treatment ]
    Patients are asked to report on their preferred pretreatment (laser or microdermabrasion) if any (at the end of the study)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin
Official Title  ICMJE Pretreatment With Ablative Fractional Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin
Brief Summary Comparison of treatment efficacy and safety of pretreatment with ablative fractional laser versus microdermabrasion combined with large-area photodynamic therapy with methyl aminolevulinate for actinic keratoses
Detailed Description

For each study participant, two test areas (A and B) are demarcated in the same anatomical region, with each area containing no less than 5 actinic keratoses (AKs). Test areas are randomized to receive skin pretreatment of EITHER ablative fractional laser OR microdermabrasion prior to photodynamic therapy using methyl aminolevulinate.

Efficacy, local skin reactions and safety of both test areas are evaluated over a 12-15 week follow up period.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Actinic Keratosis
  • Sun Damaged Skin
  • Solar Keratosis
  • Solar Skin Damage
Intervention  ICMJE
  • Device: Ablative Fractional Carbon Dioxide (CO2) Laser
    Ablative Fractional Carbon Dioxide (CO2) Laser treatment is randomly allocated to one of two tests areas in each study participant. Laser treatment consists of targeted ablation of actinic keratoses and field laser treatment of the entire test area. After laser treatment, application of methyl aminolevulinate (MAL), a topical photosensitising agent, is performed. The test area thereafter undergoes 2 hours of daylight photodynamic therapy.
  • Device: Microdermabrasion
    Microdermabrasion (processing of the skin with a sandpaper-like material) is randomly allocated to one of two tests areas in each study participant. Microdermabrasion treatment consists of targeted treatment of actinic keratoses and field treatment of the entire test area. Afterwards, application of methyl aminolevulinate (MAL), a topical photosensitising agent, is performed. The test area then undergoes 2 hours of daylight photodynamic therapy.
Study Arms  ICMJE
  • Active Comparator: Test Area A
    Two 50 cm2 test areas (Test Area A and B) are demarcated on the skin of each study participant. One test area is randomized to receive the intervention: Ablative Fractional Carbon Dioxide (CO2) Laser prior to standard daylight photodynamic therapy. The other test area is randomized to receive the intervention: microdermabrasion prior to standard daylight photodynamic therapy.
    Intervention: Device: Ablative Fractional Carbon Dioxide (CO2) Laser
  • Active Comparator: Test Area B
    Two 50 cm2 test areas (Test Area A and B) are demarcated on the skin of each study participant. One test area is randomized to receive the intervention: Ablative Fractional Carbon Dioxide (CO2) Laser prior to standard daylight photodynamic therapy. The other test area is randomized to receive the intervention: microdermabrasion prior to standard daylight photodynamic therapy.
    Intervention: Device: Microdermabrasion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 26, 2016)
18
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 1, 2017
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with two skin areas of at least 50 cm2 with a minimum of 5 actinic keratoses (AKs) grade I-III, chronically sun damaged "field" changes in one of the following anatomical regions: face, scalp, upper chest.
  • Patients who have given written informed consent and are believed to be capable of following the study protocol.
  • Fertile women must have a negative pregnancy test (urine-hCG) at the time of inclusion and use anti-contraception (oral contraceptives, intrauterine device, gestagen depot injection, subdermal implantation, vaginal ring, transdermal depot bandage or sterilisation) during the study.

Exclusion Criteria:

  • Patients that have within the last month received local treatment in the test areas.
  • Pregnant or nursing patients.
  • Patients with porphyria
  • Patients with skin cancer, keratoacanthoma, or other infiltrating tumors within the test areas.
  • Patients with a tendency to develop hypertrophic scars or keloids.
  • Patients with a known allergy to Metvix cream
  • Patients that are believe unlikely to follow the study protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03006185
Other Study ID Numbers  ICMJE H-16023991
2015-002331-18 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Merete Haedersdal, Bispebjerg Hospital
Study Sponsor  ICMJE Bispebjerg Hospital
Collaborators  ICMJE Galderma R&D
Investigators  ICMJE
Principal Investigator: Merete Haedersdal, MD, Dr. Med Bispebjerg Hospital
PRS Account Bispebjerg Hospital
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP