Ignite Creation Date:
2024-05-06 @ 3:03 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02198469
Status:
COMPLETED
Last Update Posted:
2014-07-23
First Post:
2014-07-22
Brief Title:
Study of Methyl Aminolaevulinate Photodynamic Therapy With and Without ErYAG Laser in Actinic Cheilitis
Sponsor:
Dong-A University
Organization:
Dong-A University
Study Overview
Official Title:
A Randomized Prospective Study Comparing Methyl Aminolaevulinate Photodynamic Therapy With and Without ErYAG Ablative Fractional Laser Treatment for Actinic Cheilitis
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 cheilitisAC ErYAG 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 ErYAG 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 cheilitisAC
Erbiumyttrium-aluminium-garnet ErYAG ablative fractional laser AFL therapy has been used frequently to improve treatment efficacy of PDT ErYAG 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 ErYAG AFL does not injure the entire thickness of the epidermis therefore healing times are minimised Erbiumyttrium-aluminium-garnet ErYAG 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 ErYAG AFL-assisted MAL-PDT ErYAG AFL MAL-PDT and standard MAL-PDT in patients with AC
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 cheilitisAC
Erbiumyttrium-aluminium-garnet ErYAG ablative fractional laser AFL therapy has been used frequently to improve treatment efficacy of PDT ErYAG 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 ErYAG AFL does not injure the entire thickness of the epidermis therefore healing times are minimised Erbiumyttrium-aluminium-garnet ErYAG 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 ErYAG AFL-assisted MAL-PDT ErYAG AFL MAL-PDT and standard MAL-PDT in patients with AC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None