Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Actinic Keratosis

NCT ID: NCT04396184

Last Updated: 2020-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2021-04-30

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.

Conditions

Actinic Keratosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Aminolevulinic acid photodynamic therapy

Intervention Type: PROCEDURE

Aminolevulinic acid photodynamic therapy

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.

Group Type: ACTIVE_COMPARATOR

Aminolevulinic acid photodynamic therapy

Intervention Type: PROCEDURE

Aminolevulinic acid photodynamic therapy

Interventions

Aminolevulinic acid photodynamic therapy

Aminolevulinic acid photodynamic therapy

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Dermatology Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiuli Wang

Director, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiuli Wang, PHD,MD

Role: STUDY_CHAIR

Shanghai Skin Disease Hospital

Locations

Yunfeng Zhang

Shanghai, Jinan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yunfeng Zhang, MD

Role: CONTACT

yunfeng0519116@aliyun.com

18217422425 ext. 18217422425

Haiyan Zhang, MD

Role: CONTACT

zhanghaiyan10842@163.com

18017336573

Facility Contacts

Yunfeng Zhang, MD

Role: primary

yunfeng0519116@aliyun.com

18217422425 ext. 18217422425

Haiyan Zhang, MD

Role: backup

zhanghaiyan10842@163.com

18017336573

Other Identifiers

2020-09

Identifier Type: -

Identifier Source: org_study_id