Efficacy of AFL-assisted PDT With Short Incubation Time in Actinic Keratosis
- Conditions
- Actinic Keratosis
- Interventions
- Drug: 2h-AFL-PDTDrug: 3h-AFL-PDTDrug: 3hr-MAL-PDT
- Registration Number
- NCT02248298
- Lead Sponsor
- Dong-A University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
- age >18 years
- the presence of 2-10 facial AK lesions
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description 2h-AFL-PDT 2h-AFL-PDT All 440 AK lesions of the 93 patients were randomly assigned to treatment with MAL-PDT (3h-MAL-PDT) or AFL-PDT with 2 hours (2h-AFL-PDT) and 3 hours (3h-AFL-PDT) of incubation time, using restricted randomization, with a computer-generated program. 3hr-AFL-PDT 3h-AFL-PDT All 440 AK lesions of the 93 patients were randomly assigned to treatment with MAL-PDT (3h-MAL-PDT) or AFL-PDT with 2 hours (2h-AFL-PDT) and 3 hours (3h-AFL-PDT) of incubation time, using restricted randomization, with a computer-generated program. 3hr-MAL-PDT 3hr-MAL-PDT All 440 AK lesions of the 93 patients were randomly assigned to treatment with MAL-PDT (3h-MAL-PDT) or AFL-PDT with 2 hours (2h-AFL-PDT) and 3 hours (3h-AFL-PDT) of incubation time, using restricted randomization, with a computer-generated program.
- Primary Outcome Measures
Name Time Method Difference of the efficacy between 3h-AFL-PDT, 2hr-AFL-PDT and 3h-MAL-PDT Efficacy was evaluated at 3 months and 12 months after treatment The response was classified as either complete response (complete disappearance of the lesion) or incomplete response (incomplete disappearance of the lesion)
- Secondary Outcome Measures
Name Time Method Difference of the cosmetic outcome between 3h-AFL-PDT, 2hr-AFL-PDT and 3h-MAL-PDT Cosmetic outcome was assessed by each investigator for all lesions that achieved a complete response at 12 months It was graded as excellent (slight redness or pigmentation change), good (moderate redness or pigmentation change), fair (slight-to-moderate scarring, atrophy, or induration), or poor (extensive scarring, atrophy, or induration).
Trial Locations
- Locations (1)
Dong-A University
🇰🇷Busan, Dong dae sin-dong, Seo-gu, Korea, Republic of