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

Bowen's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03320447
• Other study ID #: DAUderma-09
• Status: Completed
• Phase: Phase 1
• First received: October 19, 2017
• Last updated: October 23, 2017
• Start date: October 30, 2011
• Est. completion date: October 19, 2017

Study information

• Verified date: October 2017
• Source: Dong-A University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 19, 2017
• Est. primary completion date: October 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 42 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Bowen's Disease

Intervention

Drug:
• lidocaine-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

Device:
• 2940-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

Drug:
• methyl-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.

Device:
• Illuminating 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Differences of Adverse events(erythema, burning sensation, swelling, bleeding) between AFL-PDT and MAL-PDT	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)	Within 60 months after each treatment
Primary	Difference of short-term complete response (CR) rate between AFL-PDT and MAL-PDT	The response was classified as either complete response (complete disappearance of the lesion) or incomplete response (incomplete disappearance of the lesion)	Short-term CR rate was evaluated at 3 months
Primary	Difference of long-term complete response (CR) rate between AFL-PDT and MAL-PDT	The response was classified as either complete response (complete disappearance of the lesion) or incomplete response (incomplete disappearance of the lesion)	Long-term CR rate was evaluated at 60 months
Primary	Difference of long-term recurrence rate between AFL-PDT and MAL-PDT 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	Recurrent rate was evaluated at 60 months
Secondary	Difference of the cosmetic outcome between AFL-PDT and MAL-PDT	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)	Cosmetic outcome was assessed by each investigator for all lesions that achieved a complete response at 60 months