AcneNCT04167982
Efficacy and Safety of Painless 5-aminolevulinic Acid Photodynamic Therapy for Moderate and Severe Acne Vulgaris
A study testing Aminolevulinic acid photodynamic therapy, Oral conventional-dose isotretinoin and Oral low-dose isotretinoin in people with Acne, run by Shanghai Dermatology Hospital at 1 site in China.
Trial summary
This study is being done to compare a new, continuous illumination and short Incubation time regimen of 5-aminolevulinic acid photodynamic therapy (painless ALA- PDT) to low-dose and conventional dose of oral isotretinoin 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?
- Aminolevulinic acid photodynamic therapy, Oral conventional-dose isotretinoin and Oral low-dose isotretinoin
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2020to 30 Nov 2022
- 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 18-40 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 other treatments for various reasons 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 coagulopathy
- Those with severe neurological, psychiatric or endocrine diseases
- 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
Lei Shi
Shanghai, Shanghai Municipality, 200443
Lei Shi, MD PhD, 18017336512, leishinsh@163.com
linglin Zhang, MD, 180173336872, zhangll363@126.com
About this study
Official title: Efficacy and Safety of Painless 5-aminolevulinic Acid Photodynamic Therapy for the Treatment of Moderate and Severe Acne Vulgaris-- A Multi-center, Randomized Controlled Clinical Trial
This study is being done to compare a new, continuous illumination and short Incubation time regimen of 5-aminolevulinic acid photodynamic therapy (painless ALA- PDT) to low-dose and conventional dose of oral isotretinoin for treatment of moderate or severe acne vulgaris. The hypothesis is that the painless ALA- PDT will be equally or more efficacious as oral isotretinoin, and taking effect more quickly with less adverse effect.
- Conditions
- Acne
- Being tested
- Aminolevulinic acid photodynamic therapy, Oral conventional-dose isotretinoin, Oral low-dose isotretinoin
- Keywords
- Acne, low-dose isotretinoin, Photodynamic Therapy, Painless
- 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 therapyProcedure or surgery
Aminolevulinic acid photodynamic therapy
Oral conventional-dose isotretinoinDrug
Conventional-dose isotretinoin
Oral low-dose isotretinoinDrug
low-dose isotretinoin
| Study group | Role | What they receive |
|---|---|---|
| Painless Photodynamic Therapy(P-PDT) group | Experimental | The painless photodynamic therapy group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 150 J/cm2) after applying 5% 5-aminolevulinic acid(ALA) cream for 30min. A repeat treatment was administered once weekly for a maximum of 5 times. Blood samples, urine routine, blood biochemistry and electrocardiogram were performed before treatment and after treatment. Receives: Procedure: Aminolevulinic acid photodynamic therapy |
| conventional-dose isotretinoin group | Active comparator | Patients in the conventional-dose isotretinoin group were given oral isotretinoin 0.5 mg/kg daily for 6 months, and the cumulative dose was 90 mg/kg. Time for subsequent visit: once every two weeks during the 1st and 2nd months, monthly during 3rd to 6th months. Blood samples, urine routine, blood biochemistry and electrocardiogram were performed before treatment and 2nd , 6th months after treatment. Receives: Drug: Oral conventional-dose isotretinoin |
| low-dose isotretinoin group | Active comparator | Patients in the low-dose isotretinoin group were given oral isotretinoin 0.2 mg/kg daily for 6 months, and the cumulative dose was 36 mg/kg. Time for subsequent visit: once every two weeks during the 1st and 2nd months, monthly during 3rd to 6th months. Blood samples, urine routine, blood biochemistry and electrocardiogram were performed before treatment and 2nd , 6th months after treatment. Receives: Drug: Oral low-dose isotretinoin |
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 1st month after the last treatment
Measured: The clearance rate of Moderate or Severe Acne will be measured at 1st month after the last treatment
Secondary outcomes (1)
Pain assessment
The pain will be assessed using Visual Analogue Scale (NRS) with a score range of 0-10. The higher the score, the greater the pain, with 0 being no pain and 10 being the most unbearable pain. Pain will be measured at different time points during and after every treatment (including immediately, 1st minute, 3rd minute, 5th minute, 7th minute, 10th minute and 2nd hour, 12th hour, 24th hour and 48th hour after treatment.
Measured: immediately, 1st minute, 3rd minute, 5th minute, 7th minute, 10th minute and 2nd hour, 12th hour, 24th hour and 48th hour after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start28 Mar 2020
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2022 (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
- Outcomes assessor
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Dermatology Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Huadong Hospital, RenJi Hospital
- Responsible party
- Sponsor
- Investigators
- Xiuli Wang, MD PhD, Study chair, Shanghai Skin Disease Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167982
- Sponsor's protocol ID
- 2019-11
- Status last verified
- Nov 2020
- First submitted
- 26 Oct 2019
- Last updated
- 24 Nov 2020
- 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 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Painless 5-aminolevulinic Acid Photodynamic Therapy for the Treatment of Moderate and Severe Acne Vulgaris-- A Multi-center, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04167982
- Acronym / sponsor ID
- 2019-11
- Conditions
- Acne
- Keywords
- Acne, low-dose isotretinoin, Photodynamic Therapy, Painless
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Shanghai Dermatology HospitalUniversity, hospital or other
- Collaborators
- Huadong Hospital, RenJi Hospital
- Study start
- 28 Mar 2020 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 19 Nov 2019 (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 compare a new, continuous illumination and short Incubation time regimen of 5-aminolevulinic acid photodynamic therapy (painless ALA- PDT) to low-dose and conventional dose of oral isotretinoin for treatment of moderate or severe acne vulgaris. The hypothesis is that the painless ALA- PDT will be equally or more efficacious as oral isotretinoin, and taking effect more quickly with less adverse effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Painless Photodynamic Therapy(P-PDT) group | Experimental | Procedure: Aminolevulinic acid photodynamic therapyThe painless photodynamic therapy group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 150 J/cm2) after applying 5% 5-aminolevulinic acid(ALA) cream for 30min. A repeat treatment was administered once weekly for a maximum of 5 times. Blood samples, urine routine, blood biochemistry and electrocardiogram were performed before treatment and after treatment. |
| conventional-dose isotretinoin group | Active comparator | Drug: Oral conventional-dose isotretinoinPatients in the conventional-dose isotretinoin group were given oral isotretinoin 0.5 mg/kg daily for 6 months, and the cumulative dose was 90 mg/kg. Time for subsequent visit: once every two weeks during the 1st and 2nd months, monthly during 3rd to 6th months. Blood samples, urine routine, blood biochemistry and electrocardiogram were performed before treatment and 2nd , 6th months after treatment. |
| low-dose isotretinoin group | Active comparator | Drug: Oral low-dose isotretinoinPatients in the low-dose isotretinoin group were given oral isotretinoin 0.2 mg/kg daily for 6 months, and the cumulative dose was 36 mg/kg. Time for subsequent visit: once every two weeks during the 1st and 2nd months, monthly during 3rd to 6th months. Blood samples, urine routine, blood biochemistry and electrocardiogram were performed before treatment and 2nd , 6th months after treatment. |
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 18-40 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 (10 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 |
|---|---|---|
| Aminolevulinic acid photodynamic therapyAminolevulinic acid photodynamic therapy | Procedure or surgery | Painless Photodynamic Therapy(P-PDT) group |
| Oral conventional-dose isotretinoinConventional-dose isotretinoin | Drug | conventional-dose isotretinoin group |
| Oral low-dose isotretinoinlow-dose isotretinoin | Drug | low-dose isotretinoin group |
Primary outcome
The clearance rate of Moderate or Severe Acne
Time frame: The clearance rate of Moderate or Severe Acne will be measured at 1st month after the last treatment
The clearance rate of Moderate or Severe Acne will be measured at 1st month after the last treatment
1 secondary outcome
Pain assessment
Time frame: immediately, 1st minute, 3rd minute, 5th minute, 7th minute, 10th minute and 2nd hour, 12th hour, 24th hour and 48th hour after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- 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 chair
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, Oral conventional-dose isotretinoin and Oral low-dose isotretinoin 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 10 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 24 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Shi, MD PhD (18017336512, leishinsh@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 1st 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 24 Nov 2020.