Actinic Keratosis Clinical Trial
Official title:
Pretreatment With Ablative Fractional Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin
Verified date | September 2022 |
Source | Bispebjerg Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 18 |
Est. completion date | March 1, 2017 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bispebjerg Hospital | Galderma R&D |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete Clearance (%) of Actinic Keratoses (AKs) | Percentage clearance of baseline actinic keratoses (AKs), determined by the ratio of AK lesions that are clinically resolved 12-15 weeks after treatment compared to the AK number at baseline. | 12-15 weeks post-treatment | |
Secondary | New Actinic Keratoses (AKs) | Number of new actinic keratoses (AKs) identified clinically 12-15 weeks after treatment and that were not present at the baseline evaluation. | 12-15 weeks post-treatment | |
Secondary | Severity of Local Skin Reactions (LSRs) | Local skin reactions scale (min:0; better and max: 3; worse) used to grade each of the following parameters: erythema, edema, crusting, pustules, ulceration and scabbing, scaling.
The severity of each evaluated clinically on a 4-point scale where 0 = none, 1= mild, 2= moderate and 3= severe. With 7 parameters the sum of all scores will produce a maximum composite score of 21. |
Day 3-6 post treatment | |
Secondary | Degree of Sun Damage | Sun damage is evaluated clinically on a 4 point scale where 0 = none, 1= mild, 2= moderate and 3= severe sun damage. | 12-15 weeks post-treatment | |
Secondary | Treatment-related Pain | Patient-reported pain during treatments is evaluated using the visual analog scale (VAS) where 0= no pain and 10= worst imaginable pain. | during treatment (day 0) | |
Secondary | Treatment-related Side Effects | 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. | up to 12-15 weeks post-treatment | |
Secondary | Investigator-reported Cosmesis (Clinical Evaluation) | Cosmetic appearance of treated areas is evaluated by investigators clinically (scores on a scale) using a 4-point scale where 0 = none, 1= acceptable, 2= good and 3= excellent outcome. | 12-15 weeks post-treatment | |
Secondary | Patient-reported Cosmesis | Cosmetic appearance is evaluated by patients at the end of the study (scores on a scale) using a 4 point scale where 0 = none, 1= acceptable, 2= good and 3= excellent | 12-15 weeks post-treatment | |
Secondary | Patient Pretreatment Preference | Patients were asked to report which pretreatment they preferred: Laser, microdermabrasion, or no preference | 12-15 weeks post-treatment |
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