Efficacy in Ablative Fractional Laser Assisted Photodynamic Therapy According to Ablative Depth for Actinic Keratosis

D

Dong-A University

Status and phase

Completed
Phase 1

Conditions

Actinic Dermatosis

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

NCT03325803
DAUderma-08

Details and patient eligibility

About

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

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.

Enrollment

45 patients

Sex

All

Ages

60 to 85 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

Factorial Assignment

Masking

Triple Blind

45 participants in 3 patient groups

150μm-AFL-PDT
Experimental group
Treatment:
Drug: MAL application
Drug: lidocaine/prilocaine (5%) application
Other: Measurements of the fluorescence intensity
Device: 2940-nm Er:YAG AFL pretreatment
Device: irradiation with red light-emitting diode lamp
350μm-AFL-PDT
Experimental group
Treatment:
Drug: MAL application
Drug: lidocaine/prilocaine (5%) application
Other: Measurements of the fluorescence intensity
Device: 2940-nm Er:YAG AFL pretreatment
Device: irradiation with red light-emitting diode lamp
500μm-AFL-PDT
Experimental group
Treatment:
Drug: MAL application
Drug: lidocaine/prilocaine (5%) application
Other: Measurements of the fluorescence intensity
Device: 2940-nm Er:YAG AFL pretreatment
Device: irradiation with red light-emitting diode lamp

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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