AcneNCT05245045
Efficacy and Safety of STBF Photodynamic Therapy for Moderate and Severe Acne Vulgaris
A study testing Shengtaibufen Photodynamic Therapy(STBF-PDT) and Red light in people with Acne, run by Shanghai Dermatology Hospital at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Acne
- What is being tested?
- Shengtaibufen Photodynamic Therapy(STBF-PDT) and Red light
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2022to 10 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hospital
Shanghai, Shanghai Municipality, 200443
Haiyan Zhang, MD, zhanghaiyan10842@163.com
About this study
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.
- Conditions
- Acne
- Being tested
- Shengtaibufen Photodynamic Therapy(STBF-PDT), Red light
- Keywords
- Acne, Photodynamic Therapy, Shengtaibufen, Efficacy, Safety
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shengtaibufen Photodynamic Therapy(STBF-PDT)Procedure or surgery
Shengtaibufen Photodynamic Therapy(STBF-PDT)
Red lightProcedure or surgery
Red light
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Red light |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Immediately, 1 hour, 12 hours, 24hours and 48 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start10 Feb 2022
- Primary completion10 Feb 2023 (estimated)
- Study completion10 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Dermatology Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiuli Wang, MD, Study director, Shanghai Skin Disease Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245045
- Sponsor's protocol ID
- 2021-29
- Status last verified
- Feb 2022
- First submitted
- 9 Feb 2022
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocal
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of STBF Photodynamic Therapy for Moderate and Severe Acne Vulgaris
- ClinicalTrials.gov ID
- NCT05245045
- Acronym / sponsor ID
- 2021-29
- Conditions
- Acne
- Keywords
- Acne, Photodynamic Therapy, Shengtaibufen, Efficacy, Safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Dermatology HospitalUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 10 Feb 2023 (estimated)
- Study completion
- 10 Feb 2023 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shengtaibufen Photodynamic Therapy(STBF-PDT) | Experimental | Procedure: 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 | Placebo comparator | Procedure: Red lightThe 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shengtaibufen Photodynamic Therapy(STBF-PDT)Shengtaibufen Photodynamic Therapy(STBF-PDT) | Procedure or surgery | Shengtaibufen Photodynamic Therapy(STBF-PDT) |
| Red lightRed light | Procedure or surgery | Red light |
Primary outcome
The clearance rate of Moderate or Severe Acne
Time frame: 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
1 secondary outcome
Adverse effect
Time frame: Immediately, 1 hour, 12 hours, 24hours and 48 hours after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Individual participant dataSharing planned: Yes. study protocal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiuli Wang, MD study director
Shanghai Skin Disease Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shengtaibufen Photodynamic Therapy(STBF-PDT) and Red light in people with Acne, run by Shanghai Dermatology Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haiyan Zhang, MD (+8618017336573, zhanghaiyan10842@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clearance rate of Moderate or Severe Acne (time frame: The clearance rate of Moderate or Severe Acne will be measured at one month after the last treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.