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Efficacy of AFL-assisted PDT in Microinvasive Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT02666534
Recruitment Status : Completed
First Posted : January 28, 2016
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):
Song Ki-Hoon, Dong-A University

Brief Summary:
Surgical excision is the standard treatment for cutaneous SCC. However, many patients diagnosed with SCC are elderly and ineligible for surgery. Ablative fractional laser- assisted photodynamic therapy (AFL-PDT) offered a higher efficacy than conventional Methylaminolevulinate (MAL)-PDT.

Condition or disease Intervention/treatment Phase
Microinvasive Squamous Cell Carcinoma 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:

Squamous cell carcinoma (SCC) lesions are potentially metastatic and can be life threatening. Hence, surgical excision is the standard treatment for cutaneous SCC. However, some patients are ineligible for surgery because of their poor general health, concomitant anticoagulant or immunosuppressive therapies, or allergy to local anesthetics.

Photodynamic therapy (PDT) with methylaminolevulinate (MAL) is an innovative treatment modality that has been approved in Europe for the treatment of actinic keratosis, basal cell carcinoma, and Bowen's disease. However, currently, there is insufficient evidence to support the routine use of topical PDT for SCC.

Ablative fractional laser (AFL) ablates the epidermis and dermis without significant thermal injury, creating microscopic ablation zones in the portion of the skin that the laser is applied to. Our previous studies showed that AFL-primed MAL-PDT (AFL-PDT) offered a higher efficacy than conventional MAL-PDT in the treatment of many other diseases, such as actinic keratosis, actinic cheilitis, and Bowen's disease.

Investigators recruited Korean patients with microinvasive SCC and compared the efficacy, recurrence rate, and cosmetic outcomes of AFL-PDT with those of standard MAL-PDT.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Trial Comparing Methyl Aminolaevulinate Photodynamic Therapy With and Without Ablative Fractional Laser Treatment in Patients With Microinvasive Squamous Cell Carcinoma: Results From a 24-month Follow-up
Study Start Date : January 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AFL-PDT
Forty-five Korean patients were enrolled in this study. 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 (21 patients) or MAL-PDT (24 patients)
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.

Active Comparator: MAL-PDT
Forty-five Korean patients were enrolled in this study. 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 (21 patients) or MAL-PDT (24 patients)
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 24 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 recurrence rate at 24 months [ Time Frame: Recurrent rate was evaluated at 24months ]
    In all cases of complete response, the patients were reviewed at 24 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 24 months ]
    The overall cosmetic outcome was assessed by each investigator for all lesions that achieved complete response at 24 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 24 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:   65 Years to 89 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients aged 18 years or more who had previously untreated microinvasive SCC, providing they satisfied both of the following conditions:

    • tumor invasion into the papillary dermis (Clark level II) according to a biopsy specimen and
    • difficulty in surgical excision because of health problems (bleeding tendency or cardiac problems)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02666534


Locations
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Korea, Republic of
Dong-A University
Busan, Dong dae sin-dong, Seo-gu, Korea, Republic of, 602-715
Sponsors and Collaborators
Dong-A University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Song Ki-Hoon, Associate professor, Dong-A University
ClinicalTrials.gov Identifier: NCT02666534    
Other Study ID Numbers: DAUderma-05
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Song Ki-Hoon, Dong-A University:
Ablative fractional laser
microinvasive squamous cell carcinoma
photodynamic therapy
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
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