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

NCT03320447 | Completed Phase 1

• 1 other identifier: DAUderma-09
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bowen's Disease

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• 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

Other Outcomes (1)

• Differences of Adverse events(erythema, burning sensation, swelling, bleeding) between AFL-PDT and MAL-PDT

  Within 60 months after each treatment

Study Arms (2)

MAL-PDT

EXPERIMENTAL

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

Drug: methyl-aminolevulinate application; Device: Illuminating using red light-emitting diode lamps

AFL-PDT

EXPERIMENTAL

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

Drug: lidocaine-prilocaine 5% cream application; Device: 2940-nm Er:YAG AFL pretreatment; Drug: methyl-aminolevulinate application; Device: Illuminating using red light-emitting diode lamps

Interventions

lidocaine-prilocaine 5% cream application DRUG

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

AFL-PDT

2940-nm Er:YAG AFL pretreatment DEVICE

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

AFL-PDT

methyl-aminolevulinate application DRUG

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.

AFL-PDT; MAL-PDT

Illuminating using red light-emitting diode lamps DEVICE

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.

AFL-PDT; MAL-PDT

Eligibility Criteria

• Age: 42 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years or more who diagnosed as bowen's disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A University: lead

MeSH Terms

Conditions

Bowen's Disease

Interventions

Lidocaine, Prilocaine Drug Combination

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 25, 2017
• Study Start: October 30, 2011
• Primary Completion: October 30, 2016
• Study Completion: October 19, 2017
• Last Updated: October 25, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share