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

Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05245045
• Other study ID #: 2021-29
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2022
• Est. completion date: February 10, 2023

Study information

• Verified date: February 2022
• Source: Shanghai Dermatology Hospital
• Contact: Haiyan Zhang, MD
• Phone: +8618017336573
• Email: zhanghaiyan10842[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 10, 2023
• Est. primary completion date: February 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

Procedure:
• Shengtaibufen Photodynamic Therapy(STBF-PDT)
Shengtaibufen Photodynamic Therapy(STBF-PDT)
• Red light
Red light

Locations

Country	Name	City	State
China	Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Dermatology Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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