Clinical trial NCT04396184: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Actinic Keratosis
Keywords: Photodynamic Therapy
Conventional
Painless
Actinic Keratosis
Lead sponsor: Shanghai Dermatology Hospital
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The clearance rate of Actinic Keratoses
timeFrame: six weeks after treatment
Secondary outcomes:
measure: Pain assessment
timeFrame: Immediately, 1st minute, 3rd minute, 5th minute, 10th minute, 30th minute, 1hour ,2hour, 4hour, 12hour, 24hour,48hour ,72hour
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Yunfeng Zhang
state: Jinan
Study officials:
affiliation: Shanghai Skin Disease Hospital
name: Xiuli Wang, PHD,MD
role: STUDY_CHAIR
References: