Clinical trial NCT02248298: Efficacy of AFL-assisted PDT With Short Incubation Time in Actinic Keratosis
Official title: Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy With Short Incubation Time for the Treatment of Facial and Scalp Actinic Keratosis: 12-month Follow-up Results of a Randomized, Prospective, Comparative Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Actinic Keratosis
Keywords: Ablative fractional laser
Actinic keratosis
Efficacy
Photodynamic therapy
Short incubation time
Lead sponsor: Dong-A University
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Photodynamic therapy (PDT) using methyl aminolevulinate (MAL) is an effective first-line treatment for actinic keratosis (AK). Erbium: yttrium-aluminium-garnet (Er:YAG) ablative fractional laser-assisted MAL-PDT (AFL-PDT) has shown significant benefit for the treatment of AK. However, knowledge on the optimal photosensitizer incubation time for AFL-PDT is limited

Detailed description: Photodynamic therapy (PDT) is widely used in the treatment of superficial skin cancer. It has an excellent cosmetic outcome, and it could be considered the first-line therapy for Actinic keratosis (AK). In PDT incubation time is required so that the photosensitizer can be converted to PpIX. The recommended treatment regimen of PDT requires a relatively long incubation time with ALA (4 hours) and MAL (3 hours) before illumination. Theoretically, ablative fractional laser (AFL) pre-treatment may facilitate the penetration and distribution of topically applied drugs, since the ablated laser holes extend into the dermis, thereby possibly acting as channels for drug uptake. However, knowledge on the optimal photosensitizer incubation time for AFL-PDT is limited. The objectives of this study were to compare the efficacy, recurrence rate, cosmetic outcome, and safety between AFL-PDT with 2 and 3hours of incubation vs. conventional MAL-PDT in patients with facial and scalp AK.

Eligibility criteria: Inclusion Criteria:

* age \>18 years
* the presence of 2-10 facial AK lesions

Exclusion Criteria:

* lactating or pregnant women
* patients with porphyria
* a known allergy to any of the constituents of the MAL cream and lidocaine
* patients with systemic disease
* history of malignant melanoma
* tendency for melasma development or keloid formation
* any AK treatment of the area in the previous 4 weeks
* any conditions associated with a risk of poor protocol compliance
* patients on immunosuppressive treatment

Primary outcomes:
measure: Difference of the efficacy between 3h-AFL-PDT, 2hr-AFL-PDT and 3h-MAL-PDT
timeFrame: Efficacy was evaluated at 3 months and 12 months after treatment
Secondary outcomes:
measure: Difference of the cosmetic outcome between 3h-AFL-PDT, 2hr-AFL-PDT and 3h-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 3h-AFL-PDT, 2hr-AFL-PDT and 3h-MAL-PDT
timeFrame: within 12 months after each treatment
Locations:
city: Busan
country: Korea, Republic of
facility: Dong-A University
state: Dong dae sin-dong, Seo-gu
Study officials:
References:
citation: Choi SH, Kim KH, Song KH. Efficacy of ablative fractional laser-assisted photodynamic therapy with short-incubation time for the treatment of facial and scalp actinic keratosis: 12-month follow-up results of a randomized, prospective, comparative trial. J Eur Acad Dermatol Venereol. 2015 Aug;29(8):1598-605. doi: 10.1111/jdv.12953. Epub 2015 Feb 1.