Clinical trial NCT03642535: Aminolevulinic Acid-photodynamic Therapy for Facial Actinic Keratosis Treatment and Prevention
Official title: Aminolevulinic Acid-photodynamic Therapy for Facial Actinic Keratosis Treatment and Prevention: A Long-term (3 Years) Follow-up of Prospective, Randomized, Multicenter-clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Actinic Keratoses
Keywords: Photodynamic Therapy
Actinic Keratoses
Lead sponsor: Shanghai Dermatology Hospital
Sponsor class: OTHER
Collaborators: name: Huadong Hospital
name: Peking University First Hospital
name: First Affiliated Hospital of Kunming Medical University
name: General Hospital of Ningxia Medical University
name: Chinese Academy of Medical Sciences
First posted: 2018-08-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: Background Actinic keratoses (AKs) are often treated separately, lesion by lesion. However, in the past years, AKs have been described as a field disease and not limited to single clinically apparent lesions. Treatment should therefore target an area of field change which may treat the subclinical AKs and reduce the risk of development of further AKs, second tumours, and local recurrence.

Objectives The investigators sought to investigate whether field ALA-PDT of facial actinic keratosis would prevent new AKs, in comparison with a lesion area receiving the same ALA-PDT, in patients with clinical signs of field cancerization.

Methods Eighty patients, previously diagnosed as having AKs of the face, were randomized distribution into two groups. 10% aminolaevulinic acid (ALA)-PDT for field treatment was on one group and for a lesion area (Vehicle control cream was applied to the non-lesion area) was on the other group. During the next 5-year period of follow up, patients were clinically evaluated for new AKs.


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: Number of new Actinic Keratoses
timeFrame: 1, 3, 6, 9, 12, 18, 24, 30, 36 months after treatment
Secondary outcomes:
measure: The clearance rate of Actinic Keratoses
timeFrame: 1 month after treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Dermatology Hospital
state: Jingan
Study officials:
affiliation: Shanghai Skin Disease Hospital
name: Xiuli Wang, PHD, MD
role: STUDY_CHAIR
References:
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