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

Sponsor

Shanghai Dermatology Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04167982

Collaborator

Huadong Hospital (Other), RenJi Hospital (Other)

234

Enrollment

Location

Arms

32.1

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne	Procedure: Aminolevulinic acid photodynamic therapy Drug: Oral conventional-dose isotretinoin Drug: Oral low-dose isotretinoin	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

234 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 28, 2020

Anticipated Primary Completion Date :

Nov 30, 2022

Anticipated Study Completion Date :

Nov 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: Aminolevulinic acid photodynamic therapy Aminolevulinic acid photodynamic therapy
Active Comparator: 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.	Drug: Oral conventional-dose isotretinoin Conventional-dose isotretinoin
Active Comparator: 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.	Drug: Oral low-dose isotretinoin low-dose isotretinoin

Arm

Intervention/Treatment

Experimental: 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.

Procedure: Aminolevulinic acid photodynamic therapy

Aminolevulinic acid photodynamic therapy

Active Comparator: 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.

Drug: Oral conventional-dose isotretinoin

Conventional-dose isotretinoin

Active Comparator: 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.

Drug: Oral low-dose isotretinoin

low-dose isotretinoin

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts 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