Status:
UNKNOWN
Efficacy and Safety of STBF Photodynamic Therapy for Moderate and Severe Acne Vulgaris
Lead Sponsor:
Shanghai Dermatology Hospital
Conditions:
Acne
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
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
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 10 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05245045
Start Date
February 10 2022
End Date
February 10 2023
Last Update
February 17 2022
Active Locations (1)
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1
Hospital
Shanghai, Shanghai Municipality, China, 200443