Acne
Conditions
Keywords
Acne, Photodynamic Therapy, Shengtaibufen, Efficacy, Safety
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.
Interventions
PROCEDUREShengtaibufen Photodynamic Therapy(STBF-PDT)
Shengtaibufen Photodynamic Therapy(STBF-PDT)
PROCEDURERed light
Red light
Sponsors
Shanghai Dermatology Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosed with moderate to severe acne; 2. Male and female patients of age between 18-30 years old ; 3. All patients read the instructions of the subject, willing to follow the program requirements; 4. No other topical treatment received within 2 weeks prior to enrollment; 5. No systemic treatment was given within 4 weeks prior to enrollment; 6. 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
1. Those who did not complete the informed consent; 2. The lesions belongs to any of the following conditions: There is damage and inflammation, which may lead to the drug entering the open wound; 3. Patients with skin photoallergic diseases, porphyria; 4. Known to have a history of allergies to test drugs (porphyrins) and their chemically similar drugs; 5. Patients with other obvious diseases that may affect the evaluation of efficacy; 6. Scars or patients with a tendency to form scars; 7. Known to have severe immune dysfunction, or long-term use of glucocorticoids and immunosuppressants; 8. Severe heart, liver, kidney disease; with hereditary or acquired People with sexual coagulopathy 9. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse effect | Immediately, 1 hour, 12 hours, 24hours and 48 hours after treatment | The pain will be assessed using Visual Analogue Scale#VAS) with a score range of 0-10. Erythema edema will be observed. |
Countries
China
Contacts
Primary ContactHaiyan Zhang, MD
Outcome results
None listed