Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy According to the Laser Density for Actinic Keratosis

Dong-A University

Status and phase: Completed; Phase 4

Conditions: Actinic Keratosis

Treatments: Device: irradiation with red light-emitting diode lamp; Device: 2940-nm Er:YAG AFL pretreatment; Other: Measurements of the fluorescence intensity; Drug: MAL application; Drug: lidocaine/prilocaine (5%) application

Study type: Interventional

Funder types: Other

Identifiers

NCT03731988

DAUderma-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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47 participants in 3 patient groups

5.5% density AFL-PDT

Experimental group

Description:

After the anaesthetic cream was removed, AFL therapy was performed using a 2940-nm Er:YAG AFL (Joule; Sciton Inc., Palo Alto, CA, USA) at laser density of 5.5%, 350 µm ablation depth, level 1 coagulation and a single pulse

Treatment:

Drug: MAL application

Drug: lidocaine/prilocaine (5%) application

Device: irradiation with red light-emitting diode lamp

Other: Measurements of the fluorescence intensity

Device: 2940-nm Er:YAG AFL pretreatment

11% density AFL-PDT

Experimental group

Description:

After the anaesthetic cream was removed, AFL therapy was performed using a 2940-nm Er:YAG AFL (Joule; Sciton Inc., Palo Alto, CA, USA) at laser density of 11%, 350 µm ablation depth, level 1 coagulation and a single pulse

Treatment:

Drug: MAL application

Drug: lidocaine/prilocaine (5%) application

Device: irradiation with red light-emitting diode lamp

Other: Measurements of the fluorescence intensity

Device: 2940-nm Er:YAG AFL pretreatment

22% density AFL-PDT

Experimental group

Description:

After the anaesthetic cream was removed, AFL therapy was performed using a 2940-nm Er:YAG AFL (Joule; Sciton Inc., Palo Alto, CA, USA) at laser density of 22%, 350 µm ablation depth, level 1 coagulation and a single pulse

Treatment:

Drug: MAL application

Drug: lidocaine/prilocaine (5%) application

Device: irradiation with red light-emitting diode lamp

Other: Measurements of the fluorescence intensity

Device: 2940-nm Er:YAG AFL pretreatment