Acne VulgarisPhase 1NCT04044898
Pharmacokinetics and Safety of ALA in Acne Vulgaris
A Phase 1 study testing ALA 5% and ALA 10% in people with Acne Vulgaris, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study will evaluate the pharmacokinetics and safety of ALA in patients with moderate and severe acne vulgaris after single dose in different dosages. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- ALA 5% and ALA 10%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2021to 6 Dec 2021
- Phase
- Phase 1
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female subjects between 18 and 45 years of age (all subjects are male in pilot study);
- Diagnosis of moderate to severe facial acne vulgaris by the clinician according to the Pillsbury International Improvement Classification III-IV criteria;
- Body weight≥50 kg, body mass index (BMI) ≥19 and ≤28 kg/m2；
- Subjects (including male subjects) voluntarily adopt effective physical contraception from 14 days prior to the use of the study drug to 1 month after the end of the study, and have no fertility or donation of sperm/egg plan;
- Subjects voluntarily sign informed consent forms after being informed of the study procedures，requirements and possible adverse reactions of the study drug.
Who cannot join
- Suffer from allergic diseases ，suspect or known to have porphyrin disease or known to be allergic to test medication and/or porphyrin， or allergic persons (such as allergies to two or more drugs, food or pollen);
- Allergies to visible light
- Secondary acne patients, such as acne caused by occupational acne and corticosteroids.
- Suffering from malignant tumors and suffering from diseases such as heart, endocrine, blood, liver, immunity, metabolism, urinary system, lungs, nervous system, rheumatism/joint, mental, kidney, etc led the researchers to believe that the subject is not suitable for participating in this study
- Have been treated with systemic Vitamin A acid drugs therapy within 2 months before the study and/or antibiotics or hormonal drugs within 4 weeks before the study
- Used local topical vitamin A acid drugs within the 4 weeks before the study or patients with topical antibiotics, glucocorticoid and other topical treatment of acne drugs within the 2 weeks before the study
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- Vaccination within 4 weeks prior to the use of the study drug;
- Severe external injuries were suffered within the first 3 months (90 days) prior to the use of the study drug, or Patients who have undergone surgical treatment may significantly affect the process of studying drugs in vivo or safety assessment;
- Taked clinical trial drugs within 3 months (90 days) prior to the use of the study drug, or be participating in or plan to participate in other clinical trials during the study period.
- Drinking alcohol regularly within 3 months (90 days) prior to the use of the study drug (≥3 times a week, and the average drink is equivalent to 50° white wine ≥200 mL) or can not quit drinking during the study, or alcohol breath test positive
- Smoking cigarettes (more than 10 cigarettes or equivalent of tobacco per day) within 3 months (90 days) prior to the use of the study drug or those who cannot quit smoking during the study;
- Blood loss/blood donation more than 300 mL (except for female physiological blood loss), blood transfusion or blood product use within 3 months (90 days) prior to the use of the study drug, or plan to be blood donors during the study period or 1 month after the end of the study l (30 days) )
- Consumed excessively daily tea, coffee or caffeinated beverages (up to 8 cups per day, 200 mL per cup) within 1 month (30 days) prior to the use of the study drug;
- Drinks or food intake excessive of alcohol or caffeine (coffee, tea, cola, chocolate, etc.) within 48 hours prior to the use of the study drug ;
- Have a history of drug abuse or positive drug abuse screening;
- Hepatitis B surface antigen or hepatitis C virus antibody or treponema pallidum antibody positive or HIV Screening positive;
- Physical examination (except acne), Vital Signs, laboratory examination (blood routine, urine routine, liver function, renal function, fasting blood glucose, blood lipids, etc).and 12 lead ECG results were judged to be abnormal and clinically significant by clinicians
- Pregnant or lactating female; blood or urine pregnancy test positive
- Have a history of blood or Needles fainting, or difficulty in collecting blood
- Unable to complete the study for other reasons or Researchers believe that those who should not be included;
- Researchers and their relatives including spouses and children will be not allowed to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pharmacokinetics and Safety Study of Aminolevulinic Acid Hydrochloride Topical Powder in Subjects With Moderate to Severe Facial Acne Vulgaris.
This study will evaluate the pharmacokinetics and safety of ALA in patients with moderate and severe acne vulgaris after single dose in different dosages.
- Conditions
- Acne Vulgaris
- Being tested
- ALA 5%, ALA 10%
- Keywords
- Acne vulgaris
- 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 5%Drug
prepare 5% ALA solution, apply topically to the affected area for 1.5 hours, single dose
ALA 10%Drug
prepare 10% ALA solution, apply topically to the affected area for 3 hours, single dose
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | Not described Receives: Drug: ALA 5% |
| High dose | Experimental | Not described Receives: Drug: ALA 10% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration [Cmax]
pharmacokinetic parameter
Measured: 24 hours postdose
Area Under the Curve [AUC]
pharmacokinetic parameter
Measured: 24 hours postdose
Tmax
pharmacokinetic parameter
Measured: 24 hours postdose
Half-life Time [T1/2]
pharmacokinetic parameter
Measured: 24 hours postdose
Clearance [CL]
pharmacokinetic parameter
Measured: 24 hours postdose
Apparent Volume of Distribution [Vd]
pharmacokinetic parameter
Measured: 24 hours postdose
Maximum Plasma Concentration [Cmax](after deduction of background)
pharmacokinetic parameter
Measured: 24 hours postdose
Area Under the Curve [AUC](after deduction of background)
pharmacokinetic parameter
Measured: 24 hours postdose
Tmax(after deduction of background)
pharmacokinetic parameter
Measured: 24 hours postdose
Half-life Time [T1/2](after deduction of background)
pharmacokinetic parameter
Measured: 24 hours postdose
Clearance [CL](after deduction of background)
pharmacokinetic parameter
Measured: 24 hours postdose
Apparent Volume of Distribution [Vd](after deduction of background)
pharmacokinetic parameter
Measured: 24 hours postdose
Incidence of adverse events
Number of participants with treatment related adverse events as assessed by physical examination, vital signs, clinical laboratory values, local skin responses
Measured: 2 days postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start12 Jan 2021
- Primary completion30 Jul 2021
- Study completion6 Dec 2021
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 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
- NCT04044898
- Sponsor's protocol ID
- F0014-ALA-201811
- Status last verified
- Mar 2022
- First submitted
- 1 Aug 2019
- Last updated
- 17 Mar 2022
- 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 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetics and Safety Study of Aminolevulinic Acid Hydrochloride Topical Powder in Subjects With Moderate to Severe Facial Acne Vulgaris.
- ClinicalTrials.gov ID
- NCT04044898
- Acronym / sponsor ID
- F0014-ALA-201811
- Conditions
- Acne Vulgaris
- Keywords
- Acne vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 6 Dec 2021 (actual)
- First posted
- 5 Aug 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 will evaluate the pharmacokinetics and safety of ALA in patients with moderate and severe acne vulgaris after single dose in different dosages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: ALA 5% |
| High dose | Experimental | Drug: ALA 10% |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female subjects between 18 and 45 years of age (all subjects are male in pilot study);
- Diagnosis of moderate to severe facial acne vulgaris by the clinician according to the Pillsbury International Improvement Classification III-IV criteria;
- Body weight≥50 kg, body mass index (BMI) ≥19 and ≤28 kg/m2；
- Subjects (including male subjects) voluntarily adopt effective physical contraception from 14 days prior to the use of the study drug to 1 month after the end of the study, and have no fertility or donation of sperm/egg plan;
- Subjects voluntarily sign informed consent forms after being informed of the study procedures，requirements and possible adverse reactions of the study drug.
Key exclusion criteria (21 listed)
- Suffer from allergic diseases ，suspect or known to have porphyrin disease or known to be allergic to test medication and/or porphyrin， or allergic persons (such as allergies to two or more drugs, food or pollen);
- Allergies to visible light
- Secondary acne patients, such as acne caused by occupational acne and corticosteroids.
- Suffering from malignant tumors and suffering from diseases such as heart, endocrine, blood, liver, immunity, metabolism, urinary system, lungs, nervous system, rheumatism/joint, mental, kidney, etc led the researchers to believe that the subject is not suitable for participating in this study
- Have been treated with systemic Vitamin A acid drugs therapy within 2 months before the study and/or antibiotics or hormonal drugs within 4 weeks before the study
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 5%prepare 5% ALA solution, apply topically to the affected area for 1.5 hours, single dose | Drug | Low dose |
| ALA 10%prepare 10% ALA solution, apply topically to the affected area for 3 hours, single dose | Drug | High dose |
Primary outcome
Maximum Plasma Concentration [Cmax]
Time frame: 24 hours postdose
pharmacokinetic parameter
Area Under the Curve [AUC]
Time frame: 24 hours postdose
pharmacokinetic parameter
Tmax
Time frame: 24 hours postdose
pharmacokinetic parameter
Half-life Time [T1/2]
Time frame: 24 hours postdose
pharmacokinetic parameter
Clearance [CL]
Time frame: 24 hours postdose
pharmacokinetic parameter
Apparent Volume of Distribution [Vd]
Time frame: 24 hours postdose
pharmacokinetic parameter
Maximum Plasma Concentration [Cmax](after deduction of background)
Time frame: 24 hours postdose
pharmacokinetic parameter
Area Under the Curve [AUC](after deduction of background)
Time frame: 24 hours postdose
pharmacokinetic parameter
Tmax(after deduction of background)
Time frame: 24 hours postdose
pharmacokinetic parameter
Half-life Time [T1/2](after deduction of background)
Time frame: 24 hours postdose
pharmacokinetic parameter
Clearance [CL](after deduction of background)
Time frame: 24 hours postdose
pharmacokinetic parameter
Apparent Volume of Distribution [Vd](after deduction of background)
Time frame: 24 hours postdose
pharmacokinetic parameter
Incidence of adverse events
Time frame: 2 days postdose
Number of participants with treatment related adverse events as assessed by physical examination, vital signs, clinical laboratory values, local skin responses
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 17 Mar 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALA 5% and ALA 10% in people with Acne Vulgaris, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. 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 5 inclusion and 21 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 17 Mar 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
Maximum Plasma Concentration [Cmax] (time frame: 24 hours postdose). The study lists 13 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 17 Mar 2022.