Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy According to the Laser Density for Actinic Keratosis

NCT03731988 | Completed Phase 4

• 1 other identifier: DAUderma-10
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Erbium:yttrium aluminum garnet (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.

Conditions

Actinic Keratosis

Keywords

actinic keratosis; ablative fractional laser; photodynamic therapy; ablative density; protoporphyrin 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 methyl aminolevulinate(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)

5.5% density AFL-PDT

EXPERIMENTAL

After the anaesthetic cream was removed, AFL therapy was performed using a 2940-nm Er:YAG AFL (Joule; Sciton Inc., Palo Alto, CA, USA) at laser density of 5.5%, 350 µm ablation depth, level 1 coagulation and a single pulse

Drug: lidocaine/prilocaine (5%) application; Device: 2940-nm Er:YAG AFL pretreatment; Drug: MAL application; Other: Measurements of the fluorescence intensity; Device: irradiation with red light-emitting diode lamp

11% density AFL-PDT

EXPERIMENTAL

After the anaesthetic cream was removed, AFL therapy was performed using a 2940-nm Er:YAG AFL (Joule; Sciton Inc., Palo Alto, CA, USA) at laser density of 11%, 350 µm ablation depth, level 1 coagulation and a single pulse

Drug: lidocaine/prilocaine (5%) application; Device: 2940-nm Er:YAG AFL pretreatment; Drug: MAL application; Other: Measurements of the fluorescence intensity; Device: irradiation with red light-emitting diode lamp

22% density AFL-PDT

EXPERIMENTAL

After the anaesthetic cream was removed, AFL therapy was performed using a 2940-nm Er:YAG AFL (Joule; Sciton Inc., Palo Alto, CA, USA) at laser density of 22%, 350 µm ablation depth, level 1 coagulation and a single pulse

Drug: lidocaine/prilocaine (5%) application; Device: 2940-nm Er:YAG AFL pretreatment; Drug: MAL application; Other: Measurements of the fluorescence intensity; Device: irradiation with red light-emitting diode lamp

Interventions

lidocaine/prilocaine (5%) application DRUG

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

11% density AFL-PDT; 22% density AFL-PDT; 5.5% density AFL-PDT

2940-nm Er:YAG AFL pretreatment DEVICE

After the anaesthetic cream was removed, AFL therapy was performed using a 2940-nm Er:YAG AFL (Joule; Sciton Inc., Palo Alto, CA, USA) at 5.5% or 11% or 22% laser density with 350 µm ablation depth, level 1 coagulation and a single pulse

11% density AFL-PDT; 22% density AFL-PDT; 5.5% density AFL-PDT

MAL application DRUG

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. Incubation time is 3 hours

11% density AFL-PDT; 22% density AFL-PDT; 5.5% density AFL-PDT

Measurements of the fluorescence intensity OTHER

After 3 hours of application with MAL, saline wash was performed and fluorescence imaging analysis was performed 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 (610 nm-700 nm) was separated and extracted by Matlab program and then used to measure the amount of 633 nm fluorescence of protoporphyrin IX.

11% density AFL-PDT; 22% density AFL-PDT; 5.5% density AFL-PDT

irradiation with red light-emitting diode lamp DEVICE

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 a total light dose of 37 J/cm-2. All patients wore protective goggles during illumination.

11% density AFL-PDT; 22% density AFL-PDT; 5.5% density AFL-PDT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A University: lead

Study Sites (1)

Dong-A University

Busan, Seo-gu, 49201, South Korea

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Lidocaine; Prilocaine; Radiotherapy

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Therapeutics

Study Officials

• Ki-hoon Song, MD

  Department of Dermatology, College of Medicine, Dong-A University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 4, 2018
• First Posted: November 6, 2018
• Study Start: February 1, 2017
• Primary Completion: October 30, 2017
• Study Completion: October 24, 2018
• Last Updated: November 6, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)