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

Phase 1

Completed

• Conditions: Bowen's Disease
• Interventions: Drug: methyl-aminolevulinate application; Drug: lidocaine-prilocaine 5% cream application; Device: Illuminating using red light-emitting diode lamps

• Registration Number: NCT03320447
• Lead Sponsor: Dong-A University

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2011-10-30
• Primary Completion: 2016-10-30
• Status Verified: 2017-10
• Study Completion: 2017-10-19
• Study First Submitted: 2017-10-19
• Study First Submitted QC: 2017-10-23
• Last Update Submitted: 2017-10-23
• Study First Posted: 2017-10-25
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
MAL-PDT	methyl-aminolevulinate application	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
MAL-PDT	Illuminating using red light-emitting diode lamps	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
AFL-PDT	lidocaine-prilocaine 5% cream application	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
AFL-PDT	methyl-aminolevulinate application	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
AFL-PDT	Illuminating using red light-emitting diode lamps	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

Primary Outcome Measures

Name	Time	Method
Difference of short-term complete response (CR) rate between AFL-PDT and MAL-PDT	Short-term CR rate was evaluated at 3 months	The response was classified as either complete response (complete disappearance of the lesion) or incomplete response (incomplete disappearance of the lesion)
Difference of long-term complete response (CR) rate between AFL-PDT and MAL-PDT	Long-term CR rate was evaluated at 60 months	The response was classified as either complete response (complete disappearance of the lesion) or incomplete response (incomplete disappearance of the lesion)
Difference of long-term recurrence rate between AFL-PDT and MAL-PDT at 60 months	Recurrent rate was evaluated at 60 months	In all cases of complete response, the patients were reviewed at 60 months to check for recurrence. Post-therapy punch biopsies were performed when there was doubt concerning incomplete-response and clinical recurrence

Secondary Outcome Measures

Name	Time	Method
Difference of the cosmetic outcome between AFL-PDT and MAL-PDT	Cosmetic outcome was assessed by each investigator for all lesions that achieved a complete response at 60 months	The overall cosmetic outcome was assessed by each investigator for all lesions that achieved complete response at 60 months, and was graded using a 4-point scale: excellent (only slight occurrence of redness or change in pigmentation), good (moderate redness or change in pigmentation), fair (slight to moderate scarring, atrophy, or induration), or poor (extensive scarring, atrophy, or induration)