Clinical trial NCT02198469: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Actinic Cheilitis
Keywords: actinic cheilitis
Er:YAG ablative fractional laser
methyl aminolevulinate photodynamic therapy
Lead sponsor: Dong-A University
Sponsor class: OTHER
First posted: 2014-07-23
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 92
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Difference the efficacy between Er:YAG AFL-assisted MAL-PDT (Er:YAG AFL MAL-PDT) and standard MAL-PDT.
timeFrame: Efficacy was evaluated at 3 months and 12 months after treatment
Secondary outcomes:
measure: Difference of the cosmetic outcomes between Er:YAG AFL-assisted MAL-PDT (Er:YAG AFL MAL-PDT) and standard MAL-PDT.
timeFrame: Cosmetic outcome was assessed by each investigator for all lesions that achieved a complete response at 12 months
Other outcomes:
measure: Difference of the recurrence rates and safety between Er:YAG AFL-assisted MAL-PDT (Er:YAG AFL MAL-PDT) and standard MAL-PDT
timeFrame: within 12 months after both treatment
Locations:
city: Busan
country: Korea, Republic of
facility: Dong-A University
state: Dong dae sin-dong, Seo-gu
Study officials:
References: