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

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ClinicalTrials.gov Identifier: NCT03320447
Recruitment Status : Completed
First Posted : October 25, 2017
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
Song Ki-Hoon, Dong-A University

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.

Condition or disease Intervention/treatment Phase
Bowen's Disease 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 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 30, 2011
Actual Primary Completion Date : October 30, 2016
Actual Study Completion Date : October 19, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MAL-PDT
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
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.

Experimental: AFL-PDT
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
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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)



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Ages Eligible for Study:   42 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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Responsible Party: Song Ki-Hoon, Associate professor, Dong-A University
ClinicalTrials.gov Identifier: NCT03320447     History of Changes
Other Study ID Numbers: DAUderma-09
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Song Ki-Hoon, Dong-A University:
ablative fractional laser
photodynamic therapy
protoporphyrin IX
methy-aminolevulinate
Additional relevant MeSH terms:
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Bowen's Disease
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Lidocaine
Prilocaine
Lidocaine, Prilocaine Drug Combination
Aminolevulinic Acid
Methyl 5-aminolevulinate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Photosensitizing Agents
Dermatologic Agents
Anesthetics, Combined