Title
Efficacy and Safety of Painless 5-aminolevulinic Acid Photodynamic Therapy for Moderate and Severe Acne Vulgaris
Efficacy and Safety of Painless 5-aminolevulinic Acid Photodynamic Therapy for the Treatment of Moderate and Severe Acne Vulgaris-- A Multi-center, Randomized Controlled Clinical Trial
Phase
N/ALead Sponsor
Shanghai Dermatology HospitalStudy Type
InterventionalStatus
Unknown statusIndication/Condition
AcneIntervention/Treatment
Oral conventional-dose isotretinoin Oral low-dose isotretinoin ...Study Participants
234This study is being done to compare a new, continuous illumination and short Incubation time regimen of 5-aminolevulinic acid photodynamic therapy (painless ALA- PDT) to low-dose and conventional dose of oral isotretinoin for treatment of moderate or severe acne vulgaris. The hypothesis is that the painless ALA- PDT will be equally or more efficacious as oral isotretinoin, and taking effect more quickly with less adverse effect.
Aminolevulinic acid photodynamic therapy
Conventional-dose isotretinoin
low-dose isotretinoin
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.
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.
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.
Inclusion Criteria: Clinical diagnosed with moderate to severe acne 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: Those who did not complete the informed consent 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
