Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Actinic Keratosis

Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Actinic Keratosis#a Randomized, Open-label Trial

This study is being done to compare a new, continuous illumination and short Incubation time regimen of aminolevulinic acid photodynamic therapy#ALA-PDT) to a conventional regimen for treatment of Actinic Keratosis. The hypothesis is that the continuous illumination approach will be less or even no painful, but equally efficacious, as the old regimen.

Study Overview

• Status: Unknown
• Conditions: Actinic Keratosis
• Intervention / Treatment: Procedure: Aminolevulinic acid photodynamic therapy

Detailed Description

This study is being done to compare a new, continuous illumination and short Incubation time regimen of aminolevulinic acid photodynamic therapy#painless-PDT) to a conventional regimen for treatment of Actinic Keratosis. The hypothesis is that the continuous illumination approach will be less or even no painful, but equally efficacious, as the old regimen.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yunfeng Zhang, MD; Phone Number: 18217422425 18217422425; Email: yunfeng0519116@aliyun.com
• Study Contact Backup: Name: Haiyan Zhang, MD; Phone Number: 18017336573; Email: zhanghaiyan10842@163.com

Study Locations

• China
  • Jinan
    • Shanghai, Jinan, China, 200443
      • Recruiting
      • Yunfeng Zhang
      • Contact: Yunfeng Zhang, MD; Phone Number: 18217422425 18217422425; Email: yunfeng0519116@aliyun.com
      • Contact: Haiyan Zhang, MD; Phone Number: 18017336573; Email: zhanghaiyan10842@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Clinical diagnosed with AK (OLSEN classification grade I, II, III), aged > 18 years (Because no dosing or adverse event data are currently available on the use of topical aminolevulinic acid in patients <18 years of age, children are excluded from this study);
2. All patients are unfit and reluctant to undergo surgery for any reasons, and volunteered to participate in the study and ability to understand and the willingness to sign a written informed consent. Patents are willing to pay for the treatment, and agreed to take a picture of the skin lesions.

Exclusion Criteria:

1. Those who had ALA-PDT and any other studies that affect this study within 12 weeks ;
2. There are other facial diseases that may affect the efficacy evaluation, such as other photodermatosis;
3. Take phototoxic or photosensitizer within 8 weeks;
4. Clinical and / or pathological prove that the tumor has invaded other organs or tissues;
5. Serious immunocompromised persons;
6. scar constitution;
7. Patients are known to have skin photosensitivity, porphyria, or allergies to ALA, light or lidocaine;
8. Persons are suffering from severe internal diseases, mental and mental illness, infectious diseases or pregnant or lactating women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Painless Photodynamic Therapy(P-PDT) group; The painless photodynamic therapy group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 288 J/cm2) after applying 5% 5-aminolevulinic acid#ALA#cream for 30min. A repeat treatment was administered once every two weeks for 3 times.	Procedure: Aminolevulinic acid photodynamic therapy; Aminolevulinic acid photodynamic therapy
ACTIVE_COMPARATOR: Conventional Photodynamic Therapy(C-PDT) group; The conventional photodynamic therapy(C-PDT) group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 140 J/cm2) after applying 5% 5-aminolevulinic acid cream for 3h.A repeat treatment was administered once every two weeks for 3 times.	Procedure: Aminolevulinic acid photodynamic therapy; Aminolevulinic acid photodynamic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The clearance rate of Actinic Keratoses	The change rate in lesion clearance of Actinic Keratoses at six weeks after treatment will be measured as the primary outcome	six weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment	The pain will be assessed using Vissual Analogue Scale(VAS) with a score range of 0-10.The higher the score,the greater the pain, with 0 being no pain and 10 being the most unbearable pain. Pain will be measured at different time points during and after every treatment	Immediately, 1st minute, 3rd minute, 5th minute, 10th minute, 30th minute, 1hour ,2hour, 4hour, 12hour, 24hour,48hour ,72hour

Collaborators and Investigators

• Sponsor: Shanghai Dermatology Hospital
• Investigators: Study Chair: Xiuli Wang, PHD,MD, Shanghai Skin Disease Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2020
• Primary Completion (ANTICIPATED): April 30, 2021
• Study Completion (ANTICIPATED): April 30, 2021

Study Registration Dates

• First Submitted: May 17, 2020
• First Submitted That Met QC Criteria: May 17, 2020
• First Posted (ACTUAL): May 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 20, 2020
• Last Update Submitted That Met QC Criteria: May 17, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Actinic Keratosis; Photodynamic Therapy; Conventional; Painless
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis; Photosensitizing Agents; Dermatologic Agents; Aminolevulinic Acid
• Other Study ID Numbers: 2020-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: underlie results
• IPD Sharing Time Frame: One year after finishing this srudy and for permanency
• IPD Sharing Access Criteria: anyone who search pubmed
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No