Efficacy and Safety of STBF Photodynamic Therapy for Moderate and Severe Acne Vulgaris

Study Overview
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Brief Summary
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This study is being done to evaluate the efficacy and safety of Shengtaibufen photodynamic therapy (STBF-PDT) for treatment of moderate or severe acne vulgaris.

Detailed Description
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This study is a split randomized controlled trial and being done to evaluate the efficacy and safety of Shengtaibufen photodynamic therapy (STBF-PDT) for treatment of moderate or severe acne vulgaris.

Official Title
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Efficacy and Safety of STBF Photodynamic Therapy for Moderate and Severe Acne Vulgaris

Conditions
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Acne

Intervention / Treatment
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* Procedure: Shengtaibufen Photodynamic Therapy(STBF-PDT)
* Procedure: Red light


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosed with moderate to severe acne; Male and female patients of age between 18-30 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 surgery for various reasons,unwilling to undergo surgery, 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 People with sexual coagulopathy Those with severe neurological, psychiatric or endocrine diseases; (10)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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shengtaibufen Photodynamic Therapy(STBF-PDT)<br>The Shengtaibufen photodynamic therapy group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 150 J/cm2) after applying 0.5mg/ml Shengtaibufen solution for 45min. A repeat treatment was administered once weekly for a maximum of 3 weeks. | Procedure: Shengtaibufen Photodynamic Therapy(STBF-PDT)<br>* Shengtaibufen Photodynamic Therapy(STBF-PDT)<br>|
| Placebo Comparator: Red light<br>The Shengtaibufen photodynamic therapy group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 150 J/cm2) after applying normal saline solution for 45min. A repeat treatment was administered once weekly for a maximum of 3 weeks. | Procedure: Red light<br>* Red light<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The clearance rate of Moderate or Severe Acne | The clearance rate of Moderate or Severe Acne will be measured at one month after the last treatment | The clearance rate of Moderate or Severe Acne will be measured at one month after the last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effect | The pain will be assessed using Visual Analogue Scale#VAS) with a score range of 0-10. Erythema edema will be observed. | Immediately, 1 hour, 12 hours, 24hours and 48 hours after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne, Photodynamic Therapy, Shengtaibufen, Efficacy, Safety