NCT05245045

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

February 10, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2023

Completed
Last Updated

February 17, 2022

Status Verified

February 1, 2022

Enrollment Period

1 year

First QC Date

February 9, 2022

Last Update Submit

February 16, 2022

Conditions

Acne

Keywords

AcnePhotodynamic TherapyShengtaibufenEfficacySafety

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Adverse effect

    Immediately, 1 hour, 12 hours, 24hours and 48 hours after treatment

Study Arms (2)

Shengtaibufen Photodynamic Therapy(STBF-PDT)

EXPERIMENTAL

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)

Red light

PLACEBO COMPARATOR

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

Interventions

Shengtaibufen Photodynamic Therapy(STBF-PDT)PROCEDURE

Shengtaibufen Photodynamic Therapy(STBF-PDT)

Shengtaibufen Photodynamic Therapy(STBF-PDT)
Red lightPROCEDURE

Red light

Red light

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital

Shanghai, Shanghai Municipality, 200443, China

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Red Light

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

LightElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaOptical PhenomenaRadiationRadiation, Nonionizing

Study Officials

  • Xiuli Wang, MD

    Shanghai Skin Disease Hospital

    STUDY DIRECTOR

Central Study Contacts

Haiyan Zhang, MD

CONTACT

+8618017336573zhanghaiyan10842@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2022

First Posted

February 17, 2022

Study Start

February 10, 2022

Primary Completion

February 10, 2023

Study Completion

February 10, 2023

Last Updated

February 17, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

study protocal

Shared Documents
CSR
Time Frame
One year after finishing this study and for permanency
Access Criteria
anyone who search pubmed

Locations

CN(1)