Efficacy of AFL-assisted PDT With Short Incubation Time in Actinic Keratosis

Dong-A University

Status and phase: Completed; Phase 1

Conditions: Actinic Keratosis

Treatments: Drug: 3hr-MAL-PDT; Drug: 3h-AFL-PDT; Drug: 2h-AFL-PDT

Study type: Interventional

Funder types: Other

Identifiers

NCT02248298

DAUderma-04

Details and patient eligibility

About

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

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 18 to 87 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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93 participants in 3 patient groups

2h-AFL-PDT

Experimental group

Description:

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.

Treatment:

Drug: 2h-AFL-PDT

3hr-AFL-PDT

Active Comparator group

Description:

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.

Treatment:

Drug: 3h-AFL-PDT

3hr-MAL-PDT

Active Comparator group

Description:

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.

Treatment:

Drug: 3hr-MAL-PDT