Brief Summary

Er:YAG ablative fractional laser-assisted photodynamic therapy (AFL-PDT) has shown significant benefit for the treatment of actinic keratosis(AK). Er:YAG ablative fractional laser ablates the epidermis and dermis without significant thermal injury, creating microscopic ablation zones (MAZ) in the portion of the skin that the laser is applied to. The formed MAZ depends on the laser parameters such as laser depth, laser density and laser passes, which affect the treatment outcome.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started Sep 2015

Typical duration for phase_1

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.1 years study duration

Study Start

First participant enrolled

September 1, 2015

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed

12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2017

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

October 26, 2017

Completed

4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2017

Completed

Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

1.1 years

First QC Date

October 26, 2017

Last Update Submit

October 29, 2017

Conditions

Actinic Dermatosis

Keywords

actinic keratosisablative fractional laserphotodynamic therapyablative depthprotoporphyrin IX

Outcome Measures

Primary Outcomes (4)

Differences of short-term complete response rates between 3 groups
Lesion responses were classified as either a complete response (complete disappearance of the lesion) or a noncomplete response (incomplete disappearance)
Short-term complete response rates were evaluated at 3 months after treatment
Differences of long-term complete response rates between 3 groups
In all cases of complete response, the patients were reviewed at 12 months to check for recurrence. Recurrence was assessed by inspection, dermoscopy, photography, palpation, and histologic findings. For the histopathologic evaluation of treatment response, at the 12-month follow-up visit, a 3-mm punch biopsy of the treated AK lesion was performed in all cases of clinically incomplete response.
Long-term complete response rates were evaluated at 12 months
Difference of the recurrence rates between 3 groups
In all cases of complete response, the patients were reviewed at 12 months to check for recurrence. Recurrence was assessed by inspection, dermoscopy, photography, palpation, and histologic findings. For the histopathologic evaluation of treatment response, at the 12-month follow-up visit, a 3-mm punch biopsy of the treated AK lesion was performed in all cases of clinically incomplete response.
Recurrence rates were evaluated respectively at 12 months after treatment
Differences of the fluorescence intensity between 3 groups
After 3 hours of application with MAL, Fluorescence imaging analysis was performed on treatment area with ultraviolet examination light (model 31602,356 nm; Burton Medical Products Crop.) at 10 cm height above the base of each lesion. The red fluorescence was separated and extracted by Matlab program and then used to measure the amount of 633 nm fluorescence of protoporphyrin IX.
After 3 hours of application with MAL, fluorescence intensity imaging was assessed 10 minutes before illumination.

Secondary Outcomes (2)

Differences of cosmetic outcomes between 3 groups
The overall cosmetic outcome was assessed 12 months after treatment
Difference of adverse events (erythema, post-inflammatory hyperpigmentation, edema, itching, oozing, bleeding) rates between 3 groups
Within 12 months after each treatment

Study Arms (3)

150μm-AFL-PDT

EXPERIMENTAL

Drug: lidocaine/prilocaine (5%) applicationDevice: 2940-nm Er:YAG AFL pretreatmentDrug: MAL applicationOther: Measurements of the fluorescence intensityDevice: irradiation with red light-emitting diode lamp

350μm-AFL-PDT

EXPERIMENTAL

500μm-AFL-PDT

EXPERIMENTAL

Interventions

lidocaine/prilocaine (5%) applicationDRUG

For AFL pre-treatment, lidocaine/prilocaine (5%) cream (EMLA; Astra Pharmaceuticals, LP, Westborough, MA, USA) was applied to the treatment area under occlusion for 30 min