Efficacy and Safety of Painless 5-aminolevulinic Acid Photodynamic Therapy for Moderate and Severe Acne Vulgaris
NCT ID: NCT04167982
Last Updated: 2020-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
234 participants
INTERVENTIONAL
2020-03-28
2022-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Painless Photodynamic Therapy(P-PDT) group
The painless photodynamic therapy group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 150 J/cm2) after applying 5% 5-aminolevulinic acid(ALA) cream for 30min. A repeat treatment was administered once weekly for a maximum of 5 times. Blood samples, urine routine, blood biochemistry and electrocardiogram were performed before treatment and after treatment.
Aminolevulinic acid photodynamic therapy
Aminolevulinic acid photodynamic therapy
conventional-dose isotretinoin group
Patients in the conventional-dose isotretinoin group were given oral isotretinoin 0.5 mg/kg daily for 6 months, and the cumulative dose was 90 mg/kg. Time for subsequent visit: once every two weeks during the 1st and 2nd months, monthly during 3rd to 6th months. Blood samples, urine routine, blood biochemistry and electrocardiogram were performed before treatment and 2nd , 6th months after treatment.
Oral conventional-dose isotretinoin
Conventional-dose isotretinoin
low-dose isotretinoin group
Patients in the low-dose isotretinoin group were given oral isotretinoin 0.2 mg/kg daily for 6 months, and the cumulative dose was 36 mg/kg. Time for subsequent visit: once every two weeks during the 1st and 2nd months, monthly during 3rd to 6th months. Blood samples, urine routine, blood biochemistry and electrocardiogram were performed before treatment and 2nd , 6th months after treatment.
Oral low-dose isotretinoin
low-dose isotretinoin
Interventions
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Aminolevulinic acid photodynamic therapy
Aminolevulinic acid photodynamic therapy
Oral conventional-dose isotretinoin
Conventional-dose isotretinoin
Oral low-dose isotretinoin
low-dose isotretinoin
Eligibility Criteria
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Inclusion Criteria
* Male and female patients of age between 18-40 years old
* All patients read the instructions of the subject, willing to follow the program requirements
* No other topical treatment received within 2 weeks prior to enrollment
* No systemic treatment was given within 4 weeks prior to enrollment
* Patients were unsuitable for other treatments for various reasons and signed informed consent when they had informed other alternatives and agreed to take pictures of the lesion
Exclusion Criteria
* The lesions belongs to any of the following conditions: There is damage and inflammation, which may lead to the drug entering the open wound
* Patients with skin photoallergic diseases, porphyria
* Known to have a history of allergies to test drugs (porphyrins) and their chemically similar drugs
* Patients with other obvious diseases that may affect the evaluation of efficacy
* Scars or patients with a tendency to form scars
* Known to have severe immune dysfunction, or long-term use of glucocorticoids and immunosuppressants
* Severe heart, liver, kidney disease; with hereditary or acquired coagulopathy
* Those with severe neurological, psychiatric or endocrine diseases
* Women who are pregnant, breast-feeding or using inappropriate contraceptives -Those with a history of drug abuse; those who have participated in other drug clinical trials within 4 weeks before treatment
18 Years
40 Years
ALL
No
Sponsors
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Huadong Hospital
OTHER
RenJi Hospital
OTHER
Shanghai Dermatology Hospital
OTHER
Responsible Party
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Principal Investigators
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Xiuli Wang, MD PhD
Role: STUDY_CHAIR
Shanghai Skin Disease Hospital
Locations
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Lei Shi
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Lei Shi, MD PhD
Role: primary
linglin Zhang, MD
Role: backup
Other Identifiers
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2019-11
Identifier Type: -
Identifier Source: org_study_id