Efficacy in Ablative Fractional Laser Assisted Photodynamic Therapy According to Ablative Depth for Actinic Keratosis

Phase 1

Completed

• Conditions: Actinic Dermatosis
• Interventions: Drug: lidocaine/prilocaine (5%) application; Drug: MAL application; Other: Measurements of the fluorescence intensity; Device: irradiation with red light-emitting diode lamp

• Registration Number: NCT03325803
• Lead Sponsor: Dong-A University

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.

Detailed Description

The investigators aimed to investigate whether the use of increased laser ablative depth affects the efficacy, side effects, cosmetic outcomes, and PPIX accumulation of AFL-PDT for facial AK in a randomized clinical trial.

Study Timeline

• Study Start: 2015-09-01
• Primary Completion: 2016-09-30
• Study Completion: 2017-09-20
• Status Verified: 2017-10
• Study First Submitted: 2017-10-26
• Study First Submitted QC: 2017-10-26
• Last Update Submitted: 2017-10-29
• Study First Posted: 2017-10-30
• Last Update Posted: 2017-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Korean patients aged ≥ 18 years who had biopsy-confirmed Actinic keratosis lesions

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
350μm-AFL-PDT	lidocaine/prilocaine (5%) application	-
500μm-AFL-PDT	lidocaine/prilocaine (5%) application	-
150μm-AFL-PDT	irradiation with red light-emitting diode lamp	-
500μm-AFL-PDT	irradiation with red light-emitting diode lamp	-
150μm-AFL-PDT	lidocaine/prilocaine (5%) application	-
350μm-AFL-PDT	Measurements of the fluorescence intensity	-
500μm-AFL-PDT	MAL application	-
500μm-AFL-PDT	Measurements of the fluorescence intensity	-
150μm-AFL-PDT	MAL application	-
150μm-AFL-PDT	Measurements of the fluorescence intensity	-
350μm-AFL-PDT	MAL application	-
350μm-AFL-PDT	irradiation with red light-emitting diode lamp	-

Primary Outcome Measures

Name	Time	Method
Difference of the recurrence rates between 3 groups	Recurrence rates were evaluated respectively at 12 months after treatment	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.
Differences of short-term complete response rates between 3 groups	Short-term complete response rates were evaluated at 3 months after treatment	Lesion responses were classified as either a complete response (complete disappearance of the lesion) or a noncomplete response (incomplete disappearance)
Differences of the fluorescence intensity between 3 groups	After 3 hours of application with MAL, fluorescence intensity imaging was assessed 10 minutes before illumination.	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.
Differences of long-term complete response rates between 3 groups	Long-term complete response rates were evaluated at 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Difference of adverse events (erythema, post-inflammatory hyperpigmentation, edema, itching, oozing, bleeding) rates between 3 groups	Within 12 months after each treatment	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 (i.e., erythema, post-inflammatory hyperpigmentation, oedema, itching, oozing, bleeding and so forth).
Differences of cosmetic outcomes between 3 groups	The overall cosmetic outcome was assessed 12 months after treatment	Cosmetic outcomes were 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, Seo-gu, Korea, Republic of, 602-715, Korea, Republic of