Clinical trial NCT03325803: Efficacy in Ablative Fractional Laser Assisted Photodynamic Therapy According to Ablative Depth for Actinic Keratosis
Official title: Efficacy in Ablative Fractional Laser Assisted Photodynamic Therapy According to Ablative Depth for Actinic Keratosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Actinic Dermatosis
Keywords: actinic keratosis
ablative fractional laser
photodynamic therapy
ablative depth
protoporphyrin IX
Lead sponsor: Dong-A University
Sponsor class: OTHER
First posted: 2017-10-30
Enrollment: 45
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Er:YAG ablative fractional laser-assisted photodynamic therapy (AFL-PDT) has shown significant benefit for the treatment of actinic keratosis(AK). Er:YAG ablative fractional laser ablates the epidermis and dermis without significant thermal injury, creating microscopic ablation zones (MAZ) in the portion of the skin that the laser is applied to. The formed MAZ depends on the laser parameters such as laser depth, laser density and laser passes, which affect the treatment outcome.

Detailed description: The investigators aimed to investigate whether the use of increased laser ablative depth affects the efficacy, side effects, cosmetic outcomes, and PPIX accumulation of AFL-PDT for facial AK in a randomized clinical trial.

Eligibility criteria: Inclusion Criteria:

* Korean patients aged ≥ 18 years who had biopsy-confirmed Actinic keratosis lesions

Exclusion Criteria:

* photosensitivity disorder patients
* lactating or pregnant women
* patients with porphyria or a known allergy to any of the constituents of the MAL cream and lidocaine
* patients with systemic disease, history of malignant melanoma, tendency of melasma development or keloid formation, any AK treatment of the area in the previous 4 weeks, or any conditions associated with a risk of poor protocol compliance; and patients on immunosuppressive treatment

Primary outcomes:
measure: Differences of short-term complete response rates between 3 groups
timeFrame: Short-term complete response rates were evaluated at 3 months after treatment
measure: Differences of long-term complete response rates between 3 groups
timeFrame: Long-term complete response rates were evaluated at 12 months
measure: Difference of the recurrence rates between 3 groups
timeFrame: Recurrence rates were evaluated respectively at 12 months after treatment
measure: Differences of the fluorescence intensity between 3 groups
timeFrame: After 3 hours of application with MAL, fluorescence intensity imaging was assessed 10 minutes before illumination.
Secondary outcomes:
measure: Differences of cosmetic outcomes between 3 groups
timeFrame: The overall cosmetic outcome was assessed 12 months after treatment
measure: Difference of adverse events (erythema, post-inflammatory hyperpigmentation, edema, itching, oozing, bleeding) rates between 3 groups
timeFrame: Within 12 months after each treatment
Other outcomes:
Locations:
city: Busan, Seo-gu, Korea, Republic of, 602-715
country: Korea, Republic of
facility: Dong-A University
Study officials:
References: