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

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.

Study Overview

• Status: Recruiting
• Conditions: Acne
• Intervention / Treatment: Procedure: Shengtaibufen Photodynamic Therapy(STBF-PDT); Procedure: Red light

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haiyan Zhang, MD; Phone Number: +8618017336573; Email: zhanghaiyan10842@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200443
      • Recruiting
      • Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Shengtaibufen Photodynamic Therapy(STBF-PDT); Shengtaibufen Photodynamic Therapy(STBF-PDT)
Placebo Comparator: 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.	Procedure: Red light; Red light

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Shanghai Dermatology Hospital
• Investigators: Study Director: Xiuli Wang, MD, Shanghai Skin Disease Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Anticipated): February 10, 2023
• Study Completion (Anticipated): February 10, 2023

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): February 17, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Acne; Photodynamic Therapy; Shengtaibufen
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: 2021-29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: study protocal
• IPD Sharing Time Frame: One year after finishing this study and for permanency
• IPD Sharing Access Criteria: anyone who search pubmed
• IPD Sharing Supporting Information Type: Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No