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Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Actinic Keratosis

Primary Purpose

Actinic Keratosis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Aminolevulinic acid photodynamic therapy
Sponsored by
Shanghai Dermatology Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis focused on measuring Photodynamic Therapy, Conventional, Painless, Actinic Keratosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yunfeng ZhangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Painless Photodynamic Therapy(P-PDT) group

Conventional Photodynamic Therapy(C-PDT) group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 17, 2020
Last Updated
May 17, 2020
Sponsor
Shanghai Dermatology Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04396184
Brief Title
Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Actinic Keratosis
Official Title
Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Actinic Keratosis#a Randomized, Open-label Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
April 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Dermatology Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
Keywords
Photodynamic Therapy, Conventional, Painless, Actinic Keratosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Evaluator assesses photographs without prior knowledge of intervention
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Painless Photodynamic Therapy(P-PDT) group
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional Photodynamic Therapy(C-PDT) group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Aminolevulinic acid photodynamic therapy
Intervention Description
Aminolevulinic acid photodynamic therapy
Primary Outcome Measure Information:
Title
The clearance rate of Actinic Keratoses
Description
The change rate in lesion clearance of Actinic Keratoses at six weeks after treatment will be measured as the primary outcome
Time Frame
six weeks after treatment
Secondary Outcome Measure Information:
Title
Pain assessment
Description
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
Time Frame
Immediately, 1st minute, 3rd minute, 5th minute, 10th minute, 30th minute, 1hour ,2hour, 4hour, 12hour, 24hour,48hour ,72hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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); 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: Those who had ALA-PDT and any other studies that affect this study within 12 weeks ; There are other facial diseases that may affect the efficacy evaluation, such as other photodermatosis; Take phototoxic or photosensitizer within 8 weeks; Clinical and / or pathological prove that the tumor has invaded other organs or tissues; Serious immunocompromised persons; scar constitution; Patients are known to have skin photosensitivity, porphyria, or allergies to ALA, light or lidocaine; Persons are suffering from severe internal diseases, mental and mental illness, infectious diseases or pregnant or lactating women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yunfeng Zhang, MD
Phone
18217422425
Ext
18217422425
Email
yunfeng0519116@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Haiyan Zhang, MD
Phone
18017336573
Email
zhanghaiyan10842@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiuli Wang, PHD,MD
Organizational Affiliation
Shanghai Skin Disease Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Yunfeng Zhang
City
Shanghai
State/Province
Jinan
ZIP/Postal Code
200443
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunfeng Zhang, MD
Phone
18217422425
Ext
18217422425
Email
yunfeng0519116@aliyun.com
First Name & Middle Initial & Last Name & Degree
Haiyan Zhang, MD
Phone
18017336573
Email
zhanghaiyan10842@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Actinic Keratosis

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