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

Primary Purpose

Acne

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Shengtaibufen Photodynamic Therapy(STBF-PDT)
Red light
Sponsored by
Shanghai Dermatology Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne focused on measuring Acne, Photodynamic Therapy, Shengtaibufen, Efficacy, Safety

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Shengtaibufen Photodynamic Therapy(STBF-PDT)

Red light

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse effect
The pain will be assessed using Visual Analogue Scale#VAS) with a score range of 0-10. Erythema edema will be observed.

Full Information

First Posted
February 9, 2022
Last Updated
February 16, 2022
Sponsor
Shanghai Dermatology Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05245045
Brief Title
Efficacy and Safety of STBF Photodynamic Therapy for Moderate and Severe Acne Vulgaris
Official Title
Efficacy and Safety of STBF Photodynamic Therapy for Moderate and Severe Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2022 (Actual)
Primary Completion Date
February 10, 2023 (Anticipated)
Study Completion Date
February 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Dermatology Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne
Keywords
Acne, Photodynamic Therapy, Shengtaibufen, Efficacy, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Shengtaibufen Photodynamic Therapy(STBF-PDT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Red light
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Shengtaibufen Photodynamic Therapy(STBF-PDT)
Intervention Description
Shengtaibufen Photodynamic Therapy(STBF-PDT)
Intervention Type
Procedure
Intervention Name(s)
Red light
Intervention Description
Red light
Primary Outcome Measure Information:
Title
The clearance rate of Moderate or Severe Acne
Description
The clearance rate of Moderate or Severe Acne will be measured at one month after the last treatment
Time Frame
The clearance rate of Moderate or Severe Acne will be measured at one month after the last treatment
Secondary Outcome Measure Information:
Title
Adverse effect
Description
The pain will be assessed using Visual Analogue Scale#VAS) with a score range of 0-10. Erythema edema will be observed.
Time Frame
Immediately, 1 hour, 12 hours, 24hours and 48 hours after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haiyan Zhang, MD
Phone
+8618017336573
Email
zhanghaiyan10842@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiuli Wang, MD
Organizational Affiliation
Shanghai Skin Disease Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200443
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiyan Zhang, MD
Email
zhanghaiyan10842@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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