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Study of Methyl Aminolaevulinate Photodynamic Therapy With and Without Er:YAG Laser in Actinic Cheilitis

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ClinicalTrials.gov Identifier: NCT02198469
Recruitment Status : Completed
First Posted : July 23, 2014
Last Update Posted : July 23, 2014
Sponsor:
Information provided by (Responsible Party):
Song Ki-Hoon, Dong-A University

Tracking Information
First Submitted Date  ICMJE July 22, 2014
First Posted Date  ICMJE July 23, 2014
Last Update Posted Date July 23, 2014
Study Start Date  ICMJE January 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2014)
Difference the efficacy between Er:YAG AFL-assisted MAL-PDT (Er:YAG AFL MAL-PDT) and standard MAL-PDT. [ Time Frame: Efficacy was evaluated at 3 months and 12 months after treatment ]
Lesion response was classified as either complete (complete disappearance of the lesion) or incomplete (incomplete disappearance) on the basis of visual examination and palpation. The response of each lesion was clinically evaluated
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2014)
Difference of the cosmetic outcomes between Er:YAG AFL-assisted MAL-PDT (Er:YAG AFL MAL-PDT) and standard MAL-PDT. [ Time Frame: Cosmetic outcome was assessed by each investigator for all lesions that achieved a complete response at 12 months ]
It 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 22, 2014)
Difference of the recurrence rates and safety between Er:YAG AFL-assisted MAL-PDT (Er:YAG AFL MAL-PDT) and standard MAL-PDT [ Time Frame: within 12 months after both treatment ]
If the case of complete response of lesions, all patients were reviewed at 12 months to check recurrence. Adverse events reported by the patient 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)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study of Methyl Aminolaevulinate Photodynamic Therapy With and Without Er:YAG Laser in Actinic Cheilitis
Official Title  ICMJE A Randomized, Prospective Study Comparing Methyl Aminolaevulinate Photodynamic Therapy With and Without Er:YAG Ablative Fractional Laser Treatment for Actinic Cheilitis
Brief Summary Methyl aminolaevulinate photodynamic therapy (MAL-PDT) is advantageous in that it has few cosmetic side effects and minimises patient discomfort. However, its relatively low efficacy prevents its application to the treatment of actinic cheilitis(AC). Er:YAG ablative fractional laser (AFL) treatment removes the stratum corneum to increase MAL uptake and may improve efficacy. However, no studies have directly compared the efficacy of MAL-PDT with and without Er:YAG AFL in treating AC
Detailed Description

Actinic cheilitis (AC) is a keratinocytic neoplasm of the lip, especially the lower lip, is confined to the epidermis, and results from chronic or excessive ultraviolet exposure. AC is an early manifestation of lip squamous cell carcinoma (SCC), and SCC of the lip is usually associated with an identifiable pre-existent AC. Furthermore, the likelihood that AC will progress to SCC is higher than actinic keratosis (AK). Consequently, early identification and treatment of AC is recommended. PDT involves the activation of a photosensitizer by irradiation with 400- to 700-nm light to create cytotoxic oxygen and free radicals that kill dysplastic cells.

Methyl aminolaevulinate photodynamic therapy (MAL-PDT) is advantageous in that it has few cosmetic side effects and minimises patient discomfort. However, its relatively low efficacy prevents its application to the treatment of actinic cheilitis(AC).

Erbium:yttrium-aluminium-garnet (Er:YAG) ablative fractional laser (AFL) therapy has been used frequently to improve treatment efficacy of PDT. Er:YAG AFL can ablate stratum corneum with minimal penetration depth and producing minimal thermal injury. This approach creates microscopic vertical holes in the ablated tissue, surrounded by thin layers of coagulated tissue. Er:YAG AFL does not injure the entire thickness of the epidermis; therefore, healing times are minimised. Erbium:yttrium-aluminium-garnet (Er:YAG) ablative fractional laser (AFL) has been proven in recent studies to facilitate the delivery and uptake of topical MAL deep into the skin, enhancing porphyrin synthesis and photodynamic activation.

The aim of our study was to compare efficacy, recurrence rate, cosmetic outcome, and safety between Er:YAG AFL-assisted MAL-PDT (Er:YAG AFL MAL-PDT) and standard MAL-PDT in patients with AC.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Actinic Cheilitis
Intervention  ICMJE
  • Drug: Er:YAG AFL-PDT
    Er:YAG AFL was performed with 350 µm ablation depth, level 1 coagulation, 22% treatment density, and a single pulse. MAL cream was then applied under occlusion for 3 hrs and illuminated with a red light-emitting diode light at 37 J/cm2.
    Other Name: Er:YAG ablative fractional laser-assisted MAL-PDT
  • Drug: MAL-PDT
    a 1-mm thick layer of MAL (16% Metvix® cream, PhotoCure ASA, Oslo, Norway) was applied to the lesion and to 5 mm of surrounding healthy tissue. The area was covered with an occlusive dressing (Tegaderm, 3M, Saint Paul, MN, US) for 3 hours, 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 with red light-emitting diode (LED) lamps (Aktilite CL128; Galderma, Bruchsal, Germany) with peak emission at 632 nm and total light dose of 37 J cm-2. Areas scheduled to receive MAL-PDT received the second treatment 7 days later.
    Other Name: methyl aminolaevulinate-Photodynamic therapy
Study Arms  ICMJE
  • Experimental: Er:YAG AFL-PDT
    Eligible patients were successively randomised to receive treatment with a single session of Er:YAG AFL MAL-PDT or 2 sessions of MAL-PDT with a 1-week interval between sessions
    Intervention: Drug: Er:YAG AFL-PDT
  • Active Comparator: MAL-PDT
    Eligible patients were successively randomised to receive treatment with a single session of Er:YAG AFL MAL-PDT or 2 sessions of MAL-PDT with a 1-week interval between sessions
    Intervention: Drug: MAL-PDT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2014)
33
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Korean patients ≥ 18 years of age who had biopsy-confirmed AC lesions

Exclusion Criteria:

  • porphyria
  • known allergies to the MAL cream or lidocaine
  • pregnancy
  • lactation
  • any active systemic infectious disease
  • immunosuppressive treatment
  • personal history of malignant melanoma
  • tendency towards melasma or keloid formation
  • prior treatment of the lesions within 4 weeks
  • any indication of poor compliance
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 92 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02198469
Other Study ID Numbers  ICMJE DAUderma-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Song Ki-Hoon, Dong-A University
Study Sponsor  ICMJE Dong-A University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Dong-A University
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP