Long-term Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy for Treatment of Lower Extremity Bowen's Disease

Dong-A University

Status and phase: Completed; Phase 1

Conditions: Bowen's Disease

Treatments: Device: 2940-nm Er:YAG AFL pretreatment; Device: Illuminating using red light-emitting diode lamps; Drug: methyl-aminolevulinate application; Drug: lidocaine-prilocaine 5% cream application

Study type: Interventional

Funder types: Other

Identifiers

NCT03320447

DAUderma-09

Details and patient eligibility

About

Er:YAG ablative fractional laser-assisted methyl aminolevulinate photodynamic therapy (AFL-PDT) has shown significantly higher efficacy and a lower recurrence rate at 12 months than methyl aminolevulinate photodynamic therapy (MAL-PDT) for treatment of Bowen's disease (BD). However, long-term follow up data are not available.

Full description

To compare the long-term efficacy and recurrence rates of AFL-PDT and standard MAL-PDT for the treatment of lower extremity BD.

Enrollment: 60 patients

Sex: All

Ages: 42 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• •Patients aged 18 years or more who diagnosed as bowen's disease

Exclusion criteria

• pregnancy or lactation
• active systemic infectious disease
• other inflammatory, infectious, or neoplastic skin diseases in the treated area
• allergy to MAL,other topical photosensitizers, or excipients of the cream
• history of photosensitivity
• use of immunosuppressive or photosensitizing drugs
• participation in any other investigational study in the preceding 30 days
• history or indicators of poor compliance
• Histological findings of acantholysis, desmoplasia, perineural or lymphovascular invasion, and echographic features of regional lymph node metastasis were the disease-specific exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

MAL-PDT

Experimental group

Description:

Patients were randomly assigned to receive either AFL-PDT or MAL-PDT in a 1:1 ratio. As result, the patients were randomized to treatment with AFL-PDT or MAL-PDT

Treatment:

Drug: methyl-aminolevulinate application

Device: Illuminating using red light-emitting diode lamps

AFL-PDT

Experimental group

Description:

Patients were randomly assigned to receive either AFL-PDT or MAL-PDT in a 1:1 ratio. As result, the patients were randomized to treatment with AFL-PDT or MAL-PDT

Treatment:

Device: 2940-nm Er:YAG AFL pretreatment

Drug: methyl-aminolevulinate application

Device: Illuminating using red light-emitting diode lamps

Drug: lidocaine-prilocaine 5% cream application