Clinical trial NCT04167982: Efficacy and Safety of Painless 5-aminolevulinic Acid Photodynamic Therapy for Moderate and Severe Acne Vulgaris
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acne
Keywords: Acne
low-dose isotretinoin
Photodynamic Therapy
Painless
Lead sponsor: Shanghai Dermatology Hospital
Sponsor class: OTHER
Collaborators: name: Huadong Hospital
name: RenJi Hospital
First posted: 2019-11-19
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The clearance rate of Moderate or Severe Acne
timeFrame: The clearance rate of Moderate or Severe Acne will be measured at 1st month after the last treatment
Secondary outcomes:
measure: Pain assessment
timeFrame: immediately, 1st minute, 3rd minute, 5th minute, 7th minute, 10th minute and 2nd hour, 12th hour, 24th hour and 48th hour after treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Lei Shi
state: Shanghai
Study officials:
affiliation: Shanghai Skin Disease Hospital
name: Xiuli Wang, MD PhD
role: STUDY_CHAIR
References: