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Completed

NCT Number: NCT03320447

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

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.

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Key information

Conditions

Bowen's Disease Carcinoma Carcinoma, Squamous Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

42 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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.

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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

  1. Difference of the cosmetic outcome between AFL-PDT and MAL-PDT

    Time frame: 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 outcomes

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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Dong-A University

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
Oct 25, 2017
Registry last updated
Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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