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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shengtaibufen Photodynamic Therapy(STBF-PDT) | Experimental | 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. |
|
| Red light | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shengtaibufen Photodynamic Therapy(STBF-PDT) | Procedure | Shengtaibufen Photodynamic Therapy(STBF-PDT) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haiyan Zhang, MD | Contact | +8618017336573 | zhanghaiyan10842@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiuli Wang, MD | Shanghai Skin Disease Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital | Recruiting | Shanghai | Shanghai Municipality | 200443 | China |
study protocal
One year after finishing this study and for permanency
anyone who search pubmed
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D000095742 | Red Light |
| ID | Term |
|---|---|
| D008027 | Light |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
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| Red light | Procedure | Red light |
|
| D055585 |
| Physical Phenomena |
| D055620 | Optical Phenomena |
| D011827 | Radiation |
| D011840 | Radiation, Nonionizing |