Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Actinic Keratosis

Not Applicable

• Conditions: Actinic Keratosis
• Interventions: Procedure: Aminolevulinic acid photodynamic therapy

• Registration Number: NCT04396184
• Lead Sponsor: Shanghai Dermatology Hospital

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.

Study Timeline

• Status Verified: 2020-05
• Study Start: 2020-05-01
• Study First Submitted: 2020-05-17
• Study First Submitted QC: 2020-05-17
• Last Update Submitted: 2020-05-17
• Study First Posted: 2020-05-20
• Last Update Posted: 2020-05-20
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Photodynamic Therapy(C-PDT) group	Aminolevulinic acid photodynamic therapy	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.
Painless Photodynamic Therapy(P-PDT) group	Aminolevulinic acid photodynamic therapy	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.

Primary Outcome Measures

Name	Time	Method
The clearance rate of Actinic Keratoses	six weeks after treatment	The change rate in lesion clearance of Actinic Keratoses at six weeks after treatment will be measured as the primary outcome

Secondary Outcome Measures

Name	Time	Method
Pain assessment	Immediately, 1st minute, 3rd minute, 5th minute, 10th minute, 30th minute, 1hour ,2hour, 4hour, 12hour, 24hour,48hour ,72hour	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

Trial Locations

Locations (1)

Yunfeng Zhang; 🇨🇳 Shanghai, Jinan, China