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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03320447

Enrollment

Registered

2017-10-25

Start date

2011-10-30

Completion date

2017-10-19

Last updated

2017-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowen's Disease

Keywords

ablative fractional laser, photodynamic therapy, protoporphyrin IX, methy-aminolevulinate

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.

Interventions

DRUGlidocaine-prilocaine 5% cream application

The lesions were then cleansed with saline gauze, and a lidocaine-prilocaine 5% cream (EMLA®; Astra Pharmaceuticals, LP, Westborough, MA, USA) was applied to the treatment area for 30 min under occlusion

DEVICE2940-nm Er:YAG AFL pretreatment

After the anesthetic cream was removed, AFL was performed using a 2940-nm Er:YAG AFL (Joule; Sciton, Inc., Palo Alto, CA, USA) with a 500 µm ablation depth, level 1 coagulation, 22% treatment density, and a single pulse

DRUGmethyl-aminolevulinate application

Immediately after the AFL, a 1-mm thick layer of methyl-aminolevulinate (16% Metvix® cream; PhotoCure ASA, Oslo, Norway) was applied to the lesion and to 5 mm of the surrounding healthy tissue. The area was covered with an occlusive dressing (Tegaderm; 3M, Co., Saint Paul, MN, USA) for 3 h, after which the remaining cream was removed with saline gauze, and the red fluorescence of porphyrins was visualized with Wood's light.

DEVICEIlluminating using red light-emitting diode lamps

Each treatment area was then separately illuminated using red light-emitting diode lamps (Aktilite CL128; Galderma S.A., Bruchsal, Germany) with peak emission at 632 nm and a total light dose of 37 J/cm2. Areas scheduled to receive MAL-PDT received the second treatment 7 days later. During the illumination, patients were asked to evaluate pain intensity using an 11-point visual analog scale.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

42 Years to 89 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Other

Measure	Time frame	Description
Differences of Adverse events(erythema, burning sensation, swelling, bleeding) between AFL-PDT and MAL-PDT	Within 60 months after each treatment	Adverse events reported by the patients were noted at each follow-up visit, including severity, duration, and need for additional therapy. All events due to PDT were described as phototoxic reactions(e.g erythema, burning sensation, swelling, bleeding)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026