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

Actinic Cheilitis Clinical Trial

Official title:

A Randomized, Prospective Study Comparing Methyl Aminolaevulinate Photodynamic Therapy With and Without Er:YAG Ablative Fractional Laser Treatment for Actinic Cheilitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02198469
• Other study ID #: DAUderma-03
• Status: Completed
• Phase: Phase 1
• First received: July 22, 2014
• Last updated: July 22, 2014
• Start date: January 2012
• Est. completion date: March 2014

Study information

• Verified date: July 2014
• Source: Dong-A University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 92 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Actinic Cheilitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Dong-A University	Busan	Dong dae sin-dong, Seo-gu

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Difference of the recurrence rates and safety between Er:YAG AFL-assisted MAL-PDT (Er:YAG AFL MAL-PDT) and standard MAL-PDT	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)	within 12 months after both treatment	No
Primary	Difference the efficacy between Er:YAG AFL-assisted MAL-PDT (Er:YAG AFL MAL-PDT) and standard MAL-PDT.	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	Efficacy was evaluated at 3 months and 12 months after treatment	No
Secondary	Difference of the cosmetic outcomes between Er:YAG AFL-assisted MAL-PDT (Er:YAG AFL MAL-PDT) and standard MAL-PDT.	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)	Cosmetic outcome was assessed by each investigator for all lesions that achieved a complete response at 12 months	No