Clinical trial NCT03731988: Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy According to the Laser Density for Actinic Keratosis
Official title: A Comparison of the Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy According to the Density of Ablative Laser Channel in the Treatment of Actinic Keratosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Actinic Keratosis
Keywords: actinic keratosis
ablative fractional laser
photodynamic therapy
ablative density
protoporphyrin IX
Lead sponsor: Dong-A University
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Erbium:yttrium aluminum garnet (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: This study evaluated whether different laser densities influenced the efficacy, side effects, cosmetic outcomes, and protoporphyrin IX (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
country: Korea, Republic of
facility: Dong-A University
state: Seo-gu
Study officials:
affiliation: Department of Dermatology, College of Medicine, Dong-A University
name: Ki-hoon Song, MD
role: PRINCIPAL_INVESTIGATOR
References: