Efficacy and Safety of Painless 5-aminolevulinic Acid Photodynamic Therapy for Moderate and Severe Acne Vulgaris
1 other identifier
interventional
234
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2019
CompletedFirst Posted
Study publicly available on registry
November 19, 2019
CompletedStudy Start
First participant enrolled
March 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedNovember 24, 2020
November 1, 2020
2.7 years
October 26, 2019
November 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (3)
Painless Photodynamic Therapy(P-PDT) group
EXPERIMENTALThe 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
ACTIVE COMPARATORPatients 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
ACTIVE COMPARATORPatients 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.
Interventions
Aminolevulinic acid photodynamic therapy
Conventional-dose isotretinoin
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Dermatology Hospitallead
- Huadong Hospitalcollaborator
- RenJi Hospitalcollaborator
Study Sites (1)
Lei Shi
Shanghai, Shanghai Municipality, 200443, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Xiuli Wang, MD PhD
Shanghai Skin Disease Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2019
First Posted
November 19, 2019
Study Start
March 28, 2020
Primary Completion
November 30, 2022
Study Completion
November 30, 2022
Last Updated
November 24, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- One year after finishing this study and for permanency
- Access Criteria
- anyone who search pubmed