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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
Information provided by (Responsible Party):
Merete Haedersdal, Bispebjerg Hospital

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

Condition or disease Intervention/treatment Phase
Actinic Keratosis Sun Damaged Skin Solar Keratosis Solar Skin Damage Device: Ablative Fractional Carbon Dioxide (CO2) Laser Device: Microdermabrasion Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pretreatment With Ablative Fractional Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin
Study Start Date : August 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : March 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03006185


Sponsors and Collaborators
Bispebjerg Hospital
Galderma
Investigators
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Principal Investigator: Merete Haedersdal, MD, Dr. Med Bispebjerg Hospital
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Responsible Party: Merete Haedersdal, Professor and Senior Physician, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT03006185    
Other Study ID Numbers: H-16023991
2015-002331-18 ( EudraCT Number )
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms