Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Actinic Keratosis

Shanghai Dermatology Hospital

Status: Unknown

Conditions: Actinic Keratosis

Treatments: Procedure: Aminolevulinic acid photodynamic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04396184

2020-09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

10 participants in 2 patient groups

Painless Photodynamic Therapy(P-PDT) group

Experimental group

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.

Treatment:

Procedure: Aminolevulinic acid photodynamic therapy

Conventional Photodynamic Therapy(C-PDT) group

Active Comparator group

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.

Treatment:

Procedure: Aminolevulinic acid photodynamic therapy