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

Not Applicable

• Conditions: Acne
• Interventions: Procedure: Aminolevulinic acid photodynamic therapy; Drug: Oral conventional-dose isotretinoin; Drug: Oral low-dose isotretinoin

• Registration Number: NCT04167982
• Lead Sponsor: Shanghai Dermatology Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-26
• Study First Submitted QC: 2019-11-15
• Study First Posted: 2019-11-19
• Study Start: 2020-03-28
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-11-24
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 234

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Painless Photodynamic Therapy(P-PDT) group	Aminolevulinic acid photodynamic therapy	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.
conventional-dose isotretinoin group	Oral conventional-dose isotretinoin	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.
low-dose isotretinoin group	Oral low-dose isotretinoin	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.

Primary Outcome Measures

Name	Time	Method
The clearance rate of Moderate or Severe Acne	The clearance rate of Moderate or Severe Acne will be measured at 1st month after the last treatment	The clearance rate of Moderate or Severe Acne will be measured at 1st month after the last treatment

Secondary Outcome Measures

Name	Time	Method
Pain assessment	immediately, 1st minute, 3rd minute, 5th minute, 7th minute, 10th minute and 2nd hour, 12th hour, 24th hour and 48th hour after treatment	The pain will be assessed using Visual Analogue Scale (NRS) with a score range of 0-10. The higher the score, the greater the pain, with 0 being no pain and 10 being the most unbearable pain. Pain will be measured at different time points during and after every treatment (including immediately, 1st minute, 3rd minute, 5th minute, 7th minute, 10th minute and 2nd hour, 12th hour, 24th hour and 48th hour after treatment.

Trial Locations

Locations (1)

Lei Shi; 🇨🇳 Shanghai, Shanghai, China