Long-term Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy for Treatment of Lower Extremity Bowen's Disease: A Prospective, Randomized, Controlled Trial With 5-year Follow up
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Dong-A University
- Enrollment
- 60
- Primary Endpoint
- Difference of short-term complete response (CR) rate between AFL-PDT and MAL-PDT
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 42 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
MAL-PDT
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
Intervention: methyl-aminolevulinate application (Drug)
MAL-PDT
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
Intervention: Illuminating using red light-emitting diode lamps (Device)
AFL-PDT
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
Intervention: lidocaine-prilocaine 5% cream application (Drug)
AFL-PDT
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
Intervention: methyl-aminolevulinate application (Drug)
AFL-PDT
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
Intervention: Illuminating using red light-emitting diode lamps (Device)
Outcomes
Primary Outcomes
Difference of short-term complete response (CR) rate between AFL-PDT and MAL-PDT
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- 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)
Investigators
Song Ki-Hoon
Associate professor
Dong-A University