Efficacy and Safety of Painless 5-aminolevulinic Acid Photodynamic Therapy for Moderate and Severe Acne Vulgaris

Shanghai Dermatology Hospital

Status: Unknown

Conditions: Acne

Treatments: Drug: Oral conventional-dose isotretinoin; Procedure: Aminolevulinic acid photodynamic therapy; Drug: Oral low-dose isotretinoin

Study type: Interventional

Funder types: Other

Identifiers

NCT04167982

2019-11 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 234 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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234 participants in 3 patient groups

Painless Photodynamic Therapy(P-PDT) group

Experimental group

Description:

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.

Treatment:

Procedure: Aminolevulinic acid photodynamic therapy

conventional-dose isotretinoin group

Active Comparator group

Description:

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.

Treatment:

Drug: Oral conventional-dose isotretinoin

low-dose isotretinoin group

Active Comparator group

Description:

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.

Treatment:

Drug: Oral low-dose isotretinoin