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

This 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.

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