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Status unknownNCT05245045Updated Feb 17, 2022

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

An interventional study of Shengtaibufen Photodynamic Therapy(STBF-PDT) and Red light in Acne, sponsored by Shanghai Dermatology Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-02-17.

Sponsored by Shanghai Dermatology Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acne

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Keywords

  • Acne
  • Photodynamic Therapy
  • Shengtaibufen
  • Efficacy
  • Safety
03

In context

Acne Vulgaris

750 studies on the registry are indexed under Acne Vulgaris; 89 are open to participants now.

This study's planned enrollment of 20 is below the median of 69 across 647 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Shanghai Dermatology Hospital is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
20 participants (estimated)

Study arms

  • 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)

  • 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

Interventions

  • ProcedureShengtaibufen Photodynamic Therapy(STBF-PDT)

    Shengtaibufen Photodynamic Therapy(STBF-PDT)

  • ProcedureRed light

    Red light

06

What researchers measure

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

    Time frame: The clearance rate of Moderate or Severe Acne will be measured at one month after the last treatment

Secondary outcomes

  1. Adverse effect

    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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — study protocal

Supporting information: Clinical study report

Time frame: One year after finishing this study and for permanency

Access criteria: anyone who search pubmed

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05245045
Lead sponsor
Shanghai Dermatology Hospital
Responsible party
Sponsor
First posted
Feb 17, 2022
Start date
Feb 10, 2022
Primary completion
Feb 10, 2023 (estimated)
Completion
Feb 10, 2023 (estimated)
Last update
Feb 17, 2022

Study contacts

Haiyan Zhang, MD
Contact
zhanghaiyan10842@163.com
+8618017336573
Xiuli Wang, MD
study director · Shanghai Skin Disease Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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