CompletedPhase 1

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

60 participantsStarted 2011-10-30

Plain-language 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.

Who can participate

Age range

42 Years – 89 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Difference of short-term complete response (CR) rate between AFL-PDT and MAL-PDT

Timeframe: Short-term CR rate was evaluated at 3 months

Difference of long-term complete response (CR) rate between AFL-PDT and MAL-PDT

Timeframe: Long-term CR rate was evaluated at 60 months

Difference of long-term recurrence rate between AFL-PDT and MAL-PDT at 60 months

Timeframe: Recurrent rate was evaluated at 60 months

Trial details

NCT IDNCT03320447

SponsorDong-A University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-10-30

View on ClinicalTrials.gov More Bowen's Disease trials