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

Not Applicable

• Conditions: Acne
• Interventions: Procedure: Shengtaibufen Photodynamic Therapy(STBF-PDT); Procedure: Red light

• Registration Number: NCT05245045
• Lead Sponsor: Shanghai Dermatology Hospital

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.

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-09
• Study Start: 2022-02-10
• Study First Submitted QC: 2022-02-16
• Last Update Submitted: 2022-02-16
• Study First Posted: 2022-02-17
• Last Update Posted: 2022-02-17
• Primary Completion: 2023-02-10
• Study Completion: 2023-02-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shengtaibufen Photodynamic Therapy(STBF-PDT)	Shengtaibufen Photodynamic Therapy(STBF-PDT)	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	Red light	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Hospital; 🇨🇳 Shanghai, Shanghai, China