Acne VulgarisPhase 1/2NCT04018885
A Study on Safety and Preliminary Efficacy of ALA in Acne Vulgaris
A Phase 1/2 study testing ALA 2.5%, ALA 5% and ALA 10% in people with Acne Vulgaris, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 4 sites in China.
Trial summary
The purpose of this study is to explore the safety, tolerability, and preliminary efficacy of ALA used with photodynamic therapy for the treatment of moderate to severe acne vulgaris. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- ALA 2.5%, ALA 5% and ALA 10%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 4 sitesChina
- Study dates
- 11 Jul 2019to 20 Jan 2020
- Phase
- Phase 1/2
- 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
- Chinese male or female patients aged 18 - 40 years;
- Grade III-IV facial acne vulgaris according to the Pillsbury International Improvement scale.;
- All patients claimed to take effective contraception from 14 days before to 1 month after the end of the study, (among those who had used contraceptive two weeks prior to the study, the dosage of the drug should remain the same throughout the study) and had no fertility or donation of sperm/egg plan;
- Informed consents were signed.
Who cannot join
- Suffering with malignant tumors, cardiac, endocrine, blood, liver, immunity, metabolism, urinary system, lungs, nervous system, rheumatism / joint, psychology and kidney diseases;
- Obviously abnormal liver and kidney function;
- Suffering with allergy diseases; suspected or known to have porphyria; allergic to studying drugs and / or porphyrin; allergic to visible light; allergic constitution (allergic to two or more drugs, food or pollen);
- Secondary acne patients, such as occupational acne or acne caused by corticosteroids;
- Complicated with other obvious facial skin diseases such as actinic dermatitis, psoriasis, seborrheic dermatitis, eczema, skin tumors, etc;
- Other diseases that may significantly affect the efficacy evaluation;
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- Pregnancy, lactation patients;
- Exposed to systemic retinoids 2 months prior to the study (acitretin for 6 months);
- Exposed to systemic antibiotics, glucocorticoids, spironolactone and other drugs for treating acne 4 weeks prior to the study; physical therapy for the treatment of acne;
- Exposed to topical retinoids on the face 4 weeks prior to the study or topical antibiotics, glucocorticoids, and other topical treatment 2 weeks prior to the study;
- Participated in other clinical trials 3 months prior to the study;
- Other reasons that the investigator considered inappropriate for participation in the study.
Trial locations and contacts
4 sites in 1 country.
China4 sites
The General Hospital of the People's Liberation Army
Beijing
Hospital for Skin Diseases, Chinese Academy of Medical Sciences
Nanjing, Jiangsu
Huashan Hospital
Shanghai, Shanghai Municipality, 200040
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality
About this study
Official title: A Multi-center, Open, Randomized, Parallel Group Study to Assess Safety, Tolerance and Preliminary Efficacy of ALA for the Treatment of Moderate to Severe Acne Vulgaris
The purpose of this study is to explore the safety, tolerability, and preliminary efficacy of ALA used with photodynamic therapy for the treatment of moderate to severe acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- ALA 2.5%, ALA 5%, ALA 10%
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALA 2.5%Drug
Topical treatment for photodynamic therapy, after drug incubation subsequent illumination with red light (72 J/cm2). 4 treatments at an interval of 10 (± 4) days.
ALA 5%Drug
Topical treatment for photodynamic therapy, after drug incubation subsequent illumination with red light (72 J/cm2). 4 treatments at an interval of 10 (± 4) days.
ALA 10%Drug
Topical treatment for photodynamic therapy, after drug incubation subsequent illumination with red light (72 J/cm2). 4 treatments at an interval of 10 (± 4) days.
| Study group | Role | What they receive |
|---|---|---|
| ALA 2.5% 0.5h | Experimental | Topical application of 2.5% ALA for 0.5 hour Receives: Drug: ALA 2.5% |
| ALA 2.5% 1.5h | Experimental | Topical application of 2.5% ALA for 1.5 hours Receives: Drug: ALA 2.5% |
| ALA 2.5% 3h | Experimental | Topical application of 2.5% ALA for 3 hours Receives: Drug: ALA 2.5% |
| ALA 5% 0.5h | Experimental | Topical application of 5% ALA for 0.5 hour Receives: Drug: ALA 5% |
| ALA 5% 1.5h | Experimental | Topical application of 5% ALA for 1.5 hours Receives: Drug: ALA 5% |
| ALA 5% 3h | Experimental | Topical application of 5% ALA for 3 hours Receives: Drug: ALA 5% |
| ALA 10% 0.5h | Experimental | Topical application of 10% ALA for 0.5 hour Receives: Drug: ALA 10% |
| ALA 10% 1.5h | Experimental | Topical application of 10% ALA for 1.5 hours Receives: Drug: ALA 10% |
| ALA 10% 3h | Experimental | Topical application of 10% ALA for 3 hours Receives: Drug: ALA 10% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate in Investigator's Global Assessment (IGA)(8wks)
Proportion of subjects with an assessment of clear or almost clear with at least a 2-grade improvement in IGA
Measured: 8 weeks after the last treatment
Percent Changes From Baseline in Total Lesion Counts
Measured: 8 weeks after the last treatment
Number of Participants With Treatment Related Adverse Events
Number of participants with treatment related adverse events as assessed by physical examination, vital signs, clinical laboratory values, local skin responses
Measured: up to 8 weeks after last treatment
Secondary outcomes (4)
Percent Change from Baseline in inflammatory and non-inflammatory lesion counts
Measured: 4, 8 weeks after the last treatment
Success rate in Investigator's Global Assessment (IGA)(4wks)
Proportion of subjects with an assessment of clear or almost clear with at least a 2-grade improvement in IGA
Measured: 4 weeks after the last treatment
Proportion of acne severity improvement as assessed with the Investigator's Global Assessment (IGA)
Measured: 4, 8 weeks after the last treatment
Change in Quality of Life of Subjects from Baseline
Change in Quality of life will be assessed based on Acne-specific Quality of Life Questionnaire to be filled by subjects before and 4/8 weeks after last treatment
Measured: 4, 8 weeks after the last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start11 Jul 2019
- Primary completion20 Jan 2020
- Study completion20 Jan 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018885
- Sponsor's protocol ID
- F0014-ALA-201809
- Status last verified
- Jun 2020
- First submitted
- 10 Jul 2019
- Last updated
- 2 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open, Randomized, Parallel Group Study to Assess Safety, Tolerance and Preliminary Efficacy of ALA for the Treatment of Moderate to Severe Acne Vulgaris
- ClinicalTrials.gov ID
- NCT04018885
- Acronym / sponsor ID
- F0014-ALA-201809
- Conditions
- Acne Vulgaris
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 15 Jul 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.
The purpose of this study is to explore the safety, tolerability, and preliminary efficacy of ALA used with photodynamic therapy for the treatment of moderate to severe acne vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| ALA 2.5% 0.5h | Experimental | Drug: ALA 2.5%Topical application of 2.5% ALA for 0.5 hour |
| ALA 2.5% 1.5h | Experimental | Drug: ALA 2.5%Topical application of 2.5% ALA for 1.5 hours |
| ALA 2.5% 3h | Experimental | Drug: ALA 2.5%Topical application of 2.5% ALA for 3 hours |
| ALA 5% 0.5h | Experimental | Drug: ALA 5%Topical application of 5% ALA for 0.5 hour |
| ALA 5% 1.5h | Experimental | Drug: ALA 5%Topical application of 5% ALA for 1.5 hours |
| ALA 5% 3h | Experimental | Drug: ALA 5%Topical application of 5% ALA for 3 hours |
| ALA 10% 0.5h | Experimental | Drug: ALA 10%Topical application of 10% ALA for 0.5 hour |
| ALA 10% 1.5h | Experimental | Drug: ALA 10%Topical application of 10% ALA for 1.5 hours |
| ALA 10% 3h | Experimental | Drug: ALA 10%Topical application of 10% ALA for 3 hours |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Chinese male or female patients aged 18 - 40 years;
- Grade III-IV facial acne vulgaris according to the Pillsbury International Improvement scale.;
- All patients claimed to take effective contraception from 14 days before to 1 month after the end of the study, (among those who had used contraceptive two weeks prior to the study, the dosage of the drug should remain the same throughout the study) and had no fertility or donation of sperm/egg plan;
- Informed consents were signed.
Key exclusion criteria (12 listed)
- Suffering with malignant tumors, cardiac, endocrine, blood, liver, immunity, metabolism, urinary system, lungs, nervous system, rheumatism / joint, psychology and kidney diseases;
- Obviously abnormal liver and kidney function;
- Suffering with allergy diseases; suspected or known to have porphyria; allergic to studying drugs and / or porphyrin; allergic to visible light; allergic constitution (allergic to two or more drugs, food or pollen);
- Secondary acne patients, such as occupational acne or acne caused by corticosteroids;
- Complicated with other obvious facial skin diseases such as actinic dermatitis, psoriasis, seborrheic dermatitis, eczema, skin tumors, etc;
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 |
|---|---|---|
| ALA 2.5%Topical treatment for photodynamic therapy, after drug incubation subsequent illumination with red light (72 J/cm2). 4 treatments at an interval of 10 (± 4) days. | Drug | ALA 2.5% 0.5h, ALA 2.5% 1.5h, ALA 2.5% 3h |
| ALA 5%Topical treatment for photodynamic therapy, after drug incubation subsequent illumination with red light (72 J/cm2). 4 treatments at an interval of 10 (± 4) days. | Drug | ALA 5% 0.5h, ALA 5% 1.5h, ALA 5% 3h |
| ALA 10%Topical treatment for photodynamic therapy, after drug incubation subsequent illumination with red light (72 J/cm2). 4 treatments at an interval of 10 (± 4) days. | Drug | ALA 10% 0.5h, ALA 10% 1.5h, ALA 10% 3h |
Primary outcome
Success rate in Investigator's Global Assessment (IGA)(8wks)
Time frame: 8 weeks after the last treatment
Proportion of subjects with an assessment of clear or almost clear with at least a 2-grade improvement in IGA
Percent Changes From Baseline in Total Lesion Counts
Time frame: 8 weeks after the last treatment
Number of Participants With Treatment Related Adverse Events
Time frame: up to 8 weeks after last treatment
Number of participants with treatment related adverse events as assessed by physical examination, vital signs, clinical laboratory values, local skin responses
4 secondary outcomes
Percent Change from Baseline in inflammatory and non-inflammatory lesion counts
Time frame: 4, 8 weeks after the last treatment
Success rate in Investigator's Global Assessment (IGA)(4wks)
Time frame: 4 weeks after the last treatment
Proportion of acne severity improvement as assessed with the Investigator's Global Assessment (IGA)
Time frame: 4, 8 weeks after the last treatment
Change in Quality of Life of Subjects from Baseline
Time frame: 4, 8 weeks after the last 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 2 Jun 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ALA 2.5%, ALA 5% and ALA 10% in people with Acne Vulgaris, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 4 sites 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 4 inclusion and 12 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 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Success rate in Investigator's Global Assessment (IGA)(8wks) (time frame: 8 weeks after the last treatment). The study lists 3 primary outcomes in all. 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 2 Jun 2020.