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

Brief Title

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

Official Title

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 Phase

Phase 1

Study Type

Interventional


Primary Outcome

Difference the efficacy between Er:YAG AFL-assisted MAL-PDT (Er:YAG AFL MAL-PDT) and standard MAL-PDT.

Secondary Outcome

 Difference of the cosmetic outcomes between Er:YAG AFL-assisted MAL-PDT (Er:YAG AFL MAL-PDT) and standard MAL-PDT.

Condition

Actinic Cheilitis

Intervention

Er:YAG AFL-PDT

Study Arms / Comparison Groups

 Er:YAG AFL-PDT
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

33

Start Date

January 2012

Completion Date

March 2014

Primary Completion Date

March 2014

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 92 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT02198469

Organization ID

DAUderma-03


Responsible Party

Principal Investigator

Study Sponsor

Dong-A University


Study Sponsor

, , 


Verification Date

July 2014