A Phase 1 interventional study of lidocaine-prilocaine 5% cream application and 2940-nm Er:YAG AFL pretreatment in Bowen's Disease, sponsored by Dong-A University. Completed. Open to participants aged 42 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-25.
Sponsored by Dong-A University · Phase 1, Interventional, and Treatment
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.
To compare the long-term efficacy and recurrence rates of AFL-PDT and standard MAL-PDT for the treatment of lower extremity BD.
Dong-A University is the lead sponsor of 33 studies on the registry; 1 is open to participants now.
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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
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
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
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
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.
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.
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)
Time frame: 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)
Time frame: 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
Time frame: Recurrent rate was evaluated at 60 months
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)
Time frame: Cosmetic outcome was assessed by each investigator for all lesions that achieved a complete response at 60 months
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)
Time frame: Within 60 months after each treatment
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Plan to share: No
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Bowen's Disease
Dong-A University