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

September 20, 2014 updated by: Song Ki-Hoon, Dong-A University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Dong dae sin-dong, Seo-gu
      • Busan, Dong dae sin-dong, Seo-gu, Korea, Republic of, 602-715
        • Dong-A University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 87 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 2h-AFL-PDT
AFL therapy was performed using a 2940-nm Er:YAG AFL (Joule; Sciton Inc., Palo Alto, CA, USA) at 300-550µm ablation depth, level 1 coagulation, 22% treatment density, and a single pulse. In the 3h-MAL-PDT group, the above mentioned procedures were not performed. Immediately after AFL treatment, an approximately 1-mm thick layer of MAL (Metvix, PhotoCure ASA, Oslo, Norway) was applied to the lesion and on 5 mm of surrounding normal tissue. The area was covered with an occlusive dressing (Tegaderm, 3M, St. Paul, MN, USA). After incubation for 2 hours, the dressing and cream were removed, and the area was cleansed with saline. The area was irradiated with a red light-emitting diode lamp (Aktilite CL 128; PhotoCure ASA, Oslo, Norway) with peak emission at 632 nm, placed 5 cm away from the skin surface and total light dose of 37 J/cm-2
Active Comparator: 3hr-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.
Drug: 3h-AFL-PDT
AFL therapy was performed using a 2940-nm Er:YAG AFL (Joule; Sciton Inc., Palo Alto, CA, USA) at 300-550µm ablation depth, level 1 coagulation, 22% treatment density, and a single pulse. In the 3h-MAL-PDT group, the above mentioned procedures were not performed. Immediately after AFL treatment, an approximately 1-mm thick layer of MAL (Metvix, PhotoCure ASA, Oslo, Norway) was applied to the lesion and on 5 mm of surrounding normal tissue. The area was covered with an occlusive dressing (Tegaderm, 3M, St. Paul, MN, USA). After incubation for 3 hours, the dressing and cream were removed, and the area was cleansed with saline. The area was irradiated with a red light-emitting diode lamp (Aktilite CL 128; PhotoCure ASA, Oslo, Norway) with peak emission at 632 nm, placed 5 cm away from the skin surface and total light dose of 37 J/cm-2
Active Comparator: 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.
Drug: 3hr-MAL-PDT
an approximately 1-mm thick layer of MAL (Metvix, PhotoCure ASA, Oslo, Norway) was applied to the lesion and on 5 mm of surrounding normal tissue. The area was covered with an occlusive dressing (Tegaderm, 3M, St. Paul, MN, USA). After incubation for 3 hours, the dressing and cream were removed, and the area was cleansed with saline. The area was irradiated with a red light-emitting diode lamp (Aktilite CL 128; PhotoCure ASA, Oslo, Norway) with peak emission at 632 nm, placed 5 cm away from the skin surface and total light dose of 37 J/cm-2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of the efficacy between 3h-AFL-PDT, 2hr-AFL-PDT and 3h-MAL-PDT
Time Frame: 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)
Efficacy was evaluated at 3 months and 12 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of the cosmetic outcome between 3h-AFL-PDT, 2hr-AFL-PDT and 3h-MAL-PDT
Time Frame: 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).
Cosmetic outcome was assessed by each investigator for all lesions that achieved a complete response at 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of the recurrence rates and safety between 3h-AFL-PDT, 2hr-AFL-PDT and 3h-MAL-PDT
Time Frame: within 12 months after each treatment

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 each treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

September 20, 2014

First Submitted That Met QC Criteria

September 20, 2014

First Posted (Estimate)

September 25, 2014

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 20, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAUderma-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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