Acne VulgarisPhase 1NCT06454708
Pharmacokinetics, Safety and Tolerability of Clascoterone Cream 1% in Healthy Chinese Adult Subjects
A Phase 1 study testing Clascoterone Cream 1% in people with Acne Vulgaris, run by Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. at 1 site in China.
Trial summary
The primary objective of this study is to determine the pharmacokinetics (PK) of Clascoterone Cream, 1% after single dose and repeat dose topical administrations in healthy Chinese adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Clascoterone Cream 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 12 Aug 2024
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese adult subjects, male or female;
- 18-45 years of age (18 years old and 45 years old are inclusive, on the day of signing the written informed consent);
- Males should be ≥50.0 kg females should be ≥45.0 kg, respectively, and their body mass index [BMI = weight (kg)/height2 (m2)] should be within the range of 19.0 to 28.0 kg/m2 (including critical value);
- Female subjects of childbearing potential or male subjects whose partners are of childbearing potential should agree and be able to use effective contraception from the time of signing the written informed consent to within 3 months after the last dosing (see Appendix 2 for details);
- Subjects should be able to communicate well with the investigator and complete the study as per the protocol; subjects should be fully informed about the study and sign a written informed consent voluntarily.
Who cannot join
- Subject has a previous history of chronic or serious disease;
- Subject who has undergone major surgical procedure or procedure affecting drug absorption, distribution, metabolism, or excretion within 6 months prior to screening, or plans to undergo surgery during the study;
- Subject has a history of drug abuse and drug dependence;
- Subject who has received any medication prior to screening;
- Subject has previous allergies or has allergic symptoms;
- Subject has skin damages;
Show all 18Show fewer
- Subject who has consumed alcohol regularly;
- Subject has positive testing result of drug abuse and narcotics screening ;
- Subject who has consumed excessive of strong tea, coffee, or caffeine-containing beverages;
- Subject who has been addicted to smoking;
- Subject who has intake of grapefruit-rich beverages or foods;
- Subject who has participated in a clinical study with another drug or device and has used the drug or device prior to screening
- Subject who has donated blood or bled heavily , or received a blood transfusion or used blood products; or who plans to donate blood or blood components;
- Subject has abnormal physical examination result at screening, or abnormal result of vital signs, or abnormal ECG findings;
- Subject has abnormal and clinically significant results of clinical laboratory tests;
- Subject who is a pregnant or lactation woman or has positive pregnancy test result;
- Subject who is unable to follow a uniform diet;
- Subject who has difficulty in collecting blood, has a history of needle and blood fainting or cannot tolerate venipuncture;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Phase I Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Single Dose and Repeat Dose Topical Administrations of Clascoterone Cream, 1% in Healthy Chinese Adult Subjects
The primary objective of this study is to determine the pharmacokinetics (PK) of Clascoterone Cream, 1% after single dose and repeat dose topical administrations in healthy Chinese adult subjects.
- Conditions
- Acne Vulgaris
- Being tested
- Clascoterone Cream 1%
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clascoterone Cream 1%Drug
Clascoterone Cream 1% (Winlevi) is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
| Study group | Role | What they receive |
|---|---|---|
| Clascoterone Cream 1% | Experimental | Not described Receives: Drug: Clascoterone Cream 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to maximum plasma concentration (Tmax)
Time to maximum plasma concentration
Measured: Day 1
Maximum plasma concentration (Cmax)
Maximum plasma concentration
Measured: Day 1
Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration (AUC0-t)
Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration
Measured: Day 1
Time to maximum plasma concentration (Tmax)
Time to maximum plasma concentration
Measured: Day 7
Maximum plasma concentration at steady state (Cmax,ss)
Maximum plasma concentration at steady state
Measured: Day 7
Minimum plasma concentration at steady state (Cmin,ss)
Minimum plasma concentration at steady state
Measured: Day 7
Secondary outcomes (4)
AEs and SAEs
Incidence and severity of all adverse events (AEs) and serious adverse events (SAEs), and their relevance with the investigational drug.
Measured: Day 7
Temperature
Incidence of abnormal clinically significant temperature results.
Measured: Day 7
Pulse rate
Incidence of abnormal clinically significant pulse rate results.
Measured: Day 7
Blood pressure
Incidence of abnormal clinically significant blood pressure results.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Aug 2024
- Primary completion12 Aug 2024
- Study completion12 Aug 2024
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454708
- Sponsor's protocol ID
- LWY23090P
- Status last verified
- Jun 2024
- First submitted
- 31 May 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- 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 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Phase I Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Single Dose and Repeat Dose Topical Administrations of Clascoterone Cream, 1% in Healthy Chinese Adult Subjects
- ClinicalTrials.gov ID
- NCT06454708
- Acronym / sponsor ID
- LWY23090P
- Conditions
- Acne Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 12 Aug 2024 (actual)
- Study completion
- 12 Aug 2024 (actual)
- First posted
- 12 Jun 2024 (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 primary objective of this study is to determine the pharmacokinetics (PK) of Clascoterone Cream, 1% after single dose and repeat dose topical administrations in healthy Chinese adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clascoterone Cream 1% | Experimental | Drug: Clascoterone Cream 1% |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Chinese adult subjects, male or female;
- 18-45 years of age (18 years old and 45 years old are inclusive, on the day of signing the written informed consent);
- Males should be ≥50.0 kg females should be ≥45.0 kg, respectively, and their body mass index [BMI = weight (kg)/height2 (m2)] should be within the range of 19.0 to 28.0 kg/m2 (including critical value);
- Female subjects of childbearing potential or male subjects whose partners are of childbearing potential should agree and be able to use effective contraception from the time of signing the written informed consent to within 3 months after the last dosing (see Appendix 2 for details);
- Subjects should be able to communicate well with the investigator and complete the study as per the protocol; subjects should be fully informed about the study and sign a written informed consent voluntarily.
Key exclusion criteria (18 listed)
- Subject has a previous history of chronic or serious disease;
- Subject who has undergone major surgical procedure or procedure affecting drug absorption, distribution, metabolism, or excretion within 6 months prior to screening, or plans to undergo surgery during the study;
- Subject has a history of drug abuse and drug dependence;
- Subject who has received any medication prior to screening;
- Subject has previous allergies or has allergic symptoms;
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 |
|---|---|---|
| Clascoterone Cream 1%Clascoterone Cream 1% (Winlevi) is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. | Drug | Clascoterone Cream 1% |
Primary outcome
Time to maximum plasma concentration (Tmax)
Time frame: Day 1
Time to maximum plasma concentration
Maximum plasma concentration (Cmax)
Time frame: Day 1
Maximum plasma concentration
Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration (AUC0-t)
Time frame: Day 1
Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration
Time to maximum plasma concentration (Tmax)
Time frame: Day 7
Time to maximum plasma concentration
Maximum plasma concentration at steady state (Cmax,ss)
Time frame: Day 7
Maximum plasma concentration at steady state
Minimum plasma concentration at steady state (Cmin,ss)
Time frame: Day 7
Minimum plasma concentration at steady state
4 secondary outcomes
AEs and SAEs
Time frame: Day 7
Temperature
Time frame: Day 7
Pulse rate
Time frame: Day 7
Blood pressure
Time frame: Day 7
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 28 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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 Clascoterone Cream 1% in people with Acne Vulgaris, run by Zhejiang Sunshine Mandi 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 18 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 28 Jan 2025. 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?
Time to maximum plasma concentration (Tmax) (time frame: Day 1). The study lists 6 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 28 Jan 2025.