Acne VulgarisNCT04709289
Adverse Effects of ALA-PDT for the Treatment of Moderate to Severe Acne Vulgaris: a Prospective Study
A study testing Aminolevulinic acid, photodynamic therapy in people with Acne Vulgaris, run by Shanghai Dermatology Hospital at 1 site in China.
Trial summary
To understand, prevent and treat the adverse reactions more comprehensively, we sought to systemically document the adverse effects of ALA-PDT for moderate to severe acne vulgaris. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Aminolevulinic acid, photodynamic therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 28 Feb 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Patients diagnosed with moderate to severe acne and graded grade III-IV according to Investigator's Global Assessment (IGA) ;
- (2) Patients unsuitable for drug treatment owing to various reasons and who voluntarily participated and signed informed consent following information about other alternatives;
- (3) Patients who read the instructions and were willing to follow the program requirements.
Who cannot join
- (1) Patients who had a history of photosensitive diseases;
- (2) Patients who had Modified-PDT;
- (3) Patients who had oral isotretinoin in the past 3 months, used oral contraceptives or antibiotics and underwent local or facial surgery in the past 4 weeks;
- (4) Female patients who were pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adverse Effects of ALA-PDT for the Treatment of Moderate to Severe Acne
To understand, prevent and treat the adverse reactions more comprehensively, we sought to systemically document the adverse effects of ALA-PDT for moderate to severe acne vulgaris.
Read the detailed description
To understand, prevent and treat the adverse reactions more comprehensively, we sought to systemically document the adverse effects of ALA-PDT for moderate to severe acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- Aminolevulinic acid, photodynamic therapy
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminolevulinic acid, photodynamic therapyOther
Aminolevulinic acid, photodynamic therapy
| Study group | Role | What they receive |
|---|---|---|
| Conventional Photodynamic Therapy(C-PDT) group | Experimental | The conventional photodynamic therapy(C-PDT) group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 140 J/cm2) after applying 5% 5-aminolevulinic acid cream for 3h.A repeat treatment was administered once every two weeks for 3 times. Receives: Other: Aminolevulinic acid, photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clearance rate of lesions
The change rate in lesion clearance of acne vulgaris at 7 days after treatment will be measured as the primary outcome
Measured: 1 week after treatment
Secondary outcomes (1)
Assessment of adverse effects
the incidence, severity, occurrence and duration time of erythema, pain, burning skin, itching, pustule, exudation, edema, blister, dry skin, crust and hyperpigmentation of last treatment, as well as lesion photos were detailed asked and recorded during the clinical encounter, up to 7 days after treatment.
Measured: up to 7 days after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 Jan 2020
- Primary completion1 Jan 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Dermatology Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuli Wang, Shanghai Dermatology Hospital
- Investigators
- Xiuli Wang, MD PhD, Study director, Shanghai Skin Disease Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709289
- Sponsor's protocol ID
- 2020-04
- Status last verified
- Jan 2021
- First submitted
- 10 Jan 2021
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adverse Effects of ALA-PDT for the Treatment of Moderate to Severe Acne
- ClinicalTrials.gov ID
- NCT04709289
- Acronym / sponsor ID
- 2020-04
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shanghai Dermatology HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 14 Jan 2021 (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.
To understand, prevent and treat the adverse reactions more comprehensively, we sought to systemically document the adverse effects of ALA-PDT for moderate to severe acne vulgaris.
Detailed description
To understand, prevent and treat the adverse reactions more comprehensively, we sought to systemically document the adverse effects of ALA-PDT for moderate to severe acne vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conventional Photodynamic Therapy(C-PDT) group | Experimental | Other: Aminolevulinic acid, photodynamic therapyThe conventional photodynamic therapy(C-PDT) group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 140 J/cm2) after applying 5% 5-aminolevulinic acid cream for 3h.A repeat treatment was administered once every two weeks for 3 times. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (1) Patients diagnosed with moderate to severe acne and graded grade III-IV according to Investigator's Global Assessment (IGA) ;
- (2) Patients unsuitable for drug treatment owing to various reasons and who voluntarily participated and signed informed consent following information about other alternatives;
- (3) Patients who read the instructions and were willing to follow the program requirements.
Key exclusion criteria (4 listed)
- (1) Patients who had a history of photosensitive diseases;
- (2) Patients who had Modified-PDT;
- (3) Patients who had oral isotretinoin in the past 3 months, used oral contraceptives or antibiotics and underwent local or facial surgery in the past 4 weeks;
- (4) Female patients who were pregnant or lactating.
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 |
|---|---|---|
| Aminolevulinic acid, photodynamic therapyAminolevulinic acid, photodynamic therapy | Other | Conventional Photodynamic Therapy(C-PDT) group |
Primary outcome
The clearance rate of lesions
Time frame: 1 week after treatment
The change rate in lesion clearance of acne vulgaris at 7 days after treatment will be measured as the primary outcome
1 secondary outcome
Assessment of adverse effects
Time frame: up to 7 days after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Individual participant dataSharing planned: Yes
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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 PhD 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 Aminolevulinic acid, photodynamic therapy in people with Acne Vulgaris, 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 14 Jan 2021. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clearance rate of lesions (time frame: 1 week after 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 14 Jan 2021.