Acne VulgarisPhase 3AKLIEFNCT07186413
A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris
A Phase 3 study testing Trifarotene in people with Acne Vulgaris, run by Galderma R&D at 1 site in China.
Trial summary
The primary objective is to assess the efficacy of trifarotene 50 microgram per gram (mcg/g) cream versus vehicle cream when applied once daily (QD) for 12 weeks in Chinese participants with moderate facial and truncal acne vulgaris. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Trifarotene
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 561 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2025to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants must meet the following criteria to be included in the study:
- Male or female Chinese participants aged 9 years or older at the screening visit.
- A minimum of 20 inflammatory lesions and 25 non-inflammatory lesions on the face at Screening and Baseline.
- Facial acne vulgaris severity grade 3 (moderate) on the IGA scale at Screening and Baseline.
- A minimum of 20 inflammatory lesions and 20 non-inflammatory lesions but no more than 100 non-inflammatory lesion counts on the trunk (shoulders, upper back, and upper anterior chest) reachable for self-application of investigational product by the participant at Screening and Baseline (optional criterion for participant between 9 and 11 years of age).
- Acne vulgaris severity grade 3 (moderate) on the PGA scale at Screening and Baseline visits on trunk (shoulders, upper back and upper anterior chest) reachable for self-application of investigational product by the participant (optional criterion for participants between 9 and 11 years of age).
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- Female participants of non-childbearing potential, i.e., premenstrual, or postmenopausal. Postmenopausal participants must meet one criterion at Screening:
- Absence of menstrual bleeding for 1 year before screening with no other medical reason, confirmed with follicle-stimulating hormone level in the postmenopausal range.
- Documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at least 3 months before Screening.
- Female participants of childbearing potential (i.e., fertile, after menarche and until becoming postmenopausal unless permanently sterile) must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test (UPT) at the baseline visit (with a sensitivity of 25 international units per litre [IU/L] or less). They must use at least 1 adequate and approved method of contraception throughout the study and for 1 month after the last dose of investigational product.
- Premenstrual participants who start menses during the study must use at least 1 adequate and approved method of contraception throughout the study and for 1 month after the last dose of investigational product.
- Willing and able to comply with all the time commitments and procedural requirements of the clinical study protocol.
- Understands and signs an informed consent form (ICF) at the screening visit, before any investigational procedures are performed.
- Participants who are younger than 18 years of age and whose parent/legal representative is willing/able to comply with the study requirements and understand/sign the ICF at the screening visit, before any investigational procedures are performed, will sign the assent ICF at the screening visit.
- At selected clinical sites: If a participant who is 18 years of age or older at the screening visit and agrees to participate in study photographs, verified by dating and signing a separate approved photography ICF. For participants younger than 18 years of age, an assent photography ICF signed by the participant in conjunction with a photography ICF signed by the parents(s)/legal representative at the screening visit.
- Participant is informed of terms pertaining to personal information protection and privacy and is willing to share personal information and data, in accordance with local regulations.
Who cannot join
- Participants meeting the following criteria at the screening or baseline visits are ineligible to participate in this study:
- Pregnant women (positive serum pregnancy test result at the screening visit or positive UPT at the baseline visit), breastfeeding women, or women planning a pregnancy during the study or within 1 month after the last investigational product application.
- Severe forms of acne (e.g., acne conglobata, acne fulminans) or secondary acne form (e.g., chloracne, drug-induced acne) at the screening and baseline visits.
- More than 1 nodule on the face at the screening and baseline visits.
- More than 1 nodule on the trunk at the screening and baseline visits.
- Any acne cyst on the face at the screening and baseline visits.
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- Any acne cyst on the trunk at the screening and baseline visits.
- Facial or truncal hair that may interfere with the study assessments according to investigator's judgment.
- Abnormal pigmentation, wound, scar, or tattoo on the face or on the shoulders, upper back, or chest that may interfere with the study assessments according to investigator's judgment.
- Any uncontrolled or serious disease or any medical or surgical condition that may interfere with the interpretation of the study results and/or put the participant at significant risk according to investigator's judgment.
- Abnormal laboratory test results at the screening visit (hematology, comprehensive metabolic panel, and urinalysis) judged as clinically significant by the investigator (to be checked before the baseline visit), which may interfere with the interpretation of the study results and/or put the participant at significant risk (e.g., elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (> 3 × upper limit of normal [ULN])).
- Known allergies or hypersensitivities to any component of the formulation of the investigational products (trifarotene 50 mcg/g cream or vehicle cream; see Investigator's Brochure).
- Previously participated in any trifarotene cream clinical study.
- Current participation in any other clinical study of a drug or device OR past participation within 30 days before the baseline visit.
- Alcohol or drug abuse or substance dependence within 12 months before the screening visit.
- Inability or unwillingness to undergo multiple venipunctures because of poor tolerability or venous access.
- Loss of over 500 mL of blood or blood donation within the last 3 months before the screening visit.
- Having received prohibited medication or treatment during the study.
- Exposure to excessive ultraviolet (UV) radiation within 1 month before the baseline visit.
- Unwillingness to avoid excessive or prolonged exposure to UV light (i.e., occupational exposure to the sun, sunbathing, tanning bed use, phototherapy) throughout the study.
- Any drug that in the opinion of the investigator may interfere with the study assessments or exacerbate acne, i.e., lithium, halogens, haloperidol, hydantoin, phenobarbital, Vitamin B12, androgens.
- Unwillingness to refrain from prohibited medication during the clinical study as defined by protocol.
- Participant vulnerability (such as freedom deprivation, mental disease, those incapable of giving consent) as defined in Section 1.61 of the International Council for Harmonization Guideline for Good Clinical Practice (GCP).
- More than 1 participant sharing the same household.
- Clinical site personnel, close relatives of the clinical site personnel (e.g., parents, children, siblings, or spouse), employees, or close relatives of employees of the Sponsor company.
Trial locations and contacts
1 site in 1 country.
China1 site
Galderma Research & Development Site #5378
Shanghai, Jing'an District
About this study
Official title: A Multicenter, Randomized, Double-blinded, Parallel-group, Vehicle-controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris
The primary objective is to assess the efficacy of trifarotene 50 microgram per gram (mcg/g) cream versus vehicle cream when applied once daily (QD) for 12 weeks in Chinese participants with moderate facial and truncal acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- Trifarotene, Vehicle Cream
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrifaroteneDrug
Also called CD5789
Trifarotene cream applied QD topically.
Vehicle CreamDrug
Vehicle cream applied QD topically.
| Study group | Role | What they receive |
|---|---|---|
| Trifarotene Cream | Experimental | Participants will apply Trifarotene 50 mcg/g cream once daily (QD) in the evening for 12 weeks. Receives: Drug: Trifarotene |
| Vehicle Cream | Active comparator | Participants will apply Vehicle cream QD in the evening for 12 weeks. Receives: Drug: Vehicle Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Investigator Global Assessment (IGA) Success (Face only) at Week 12
The areas defined for IGA assessment are the forehead, each cheek, chin, and nose. IGA will be confined to a global assessment of each area defined above. IGA consists of 5 grades ranging from 0-4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Success Rate, defined as the percentage of participants who achieve an IGA score (face only) of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12.
Measured: Baseline to Week 12
Change from Baseline to Week 12 in Facial Non-inflammatory Lesion Count
Measured: Baseline to Week 12
Change from Baseline to Week 12 in Facial Inflammatory Lesion Count
Measured: Baseline to Week 12
Secondary outcomes (6)
Percentage of Participants with Physician Global Assessment (PGA) Success at Week 12
The areas defined for PGA assessment are shoulders, upper back and upper anterior chest which are accessible to self-application by the participants. PGA will be confined to a global assessment of each areas defined above. The PGA is a snapshot static assessment to be done prior to detailed lesion counts. PGA consists of 5 grades ranging from 0-4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. PGA Success, defined as the percentage of participants who achieve a PGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12
Measured: Baseline to Week 12
Change from Baseline to Week 12 in Truncal Non-inflammatory Lesion Count
Measured: Baseline to Week 12
Change from Baseline to Week 12 in Truncal Inflammatory Lesion Count
Measured: Baseline to Week 12
Number of Participants With Adverse Events (AEs), Including AEs of Special Interest (AESIs), Treatment-emergent AEs (TEAEs), and Serious AEs (SAEs)
Measured: Baseline to Week 12
Investigator's Local Tolerability Assessment
Local tolerability, which includes individual assessment of erythema, scaling, dryness, and stinging/burning, will be graded on a 4-point scale (ranging from 0 [None] to 3 [Severe]) separately for the face and trunk. A higher score indicated a severe outcome. The areas for evaluation on the face include the forehead, nose, chin, and right and left cheeks. The areas for evaluation on the upper trunk include the shoulders, right and left chest, and right and left upper back, which are accessible to self-application by the subject. If IP is applied to the middle and/or lower back, the local tolerability assessment of the trunk will include the upper, middle, and/or lower back, if applicable, and will be analyzed as 1 area.
Measured: Baseline, Weeks 1, 2, 4, 8 and 12
Observed Plasma Concentration (Ct) in Selected Participants
Three PK samples will be collected to inform trifarotene exposure in adult participants.
Measured: Baseline, Week 4 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start23 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 561 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186413
- Sponsor's protocol ID
- CD5789.SPR.205101
- Acronym
- AKLIEF
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blinded, Parallel-group, Vehicle-controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT07186413
- Acronym / sponsor ID
- AKLIEF / CD5789.SPR.205101
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 561 participants (estimated)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Sep 2025 (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 is to assess the efficacy of trifarotene 50 microgram per gram (mcg/g) cream versus vehicle cream when applied once daily (QD) for 12 weeks in Chinese participants with moderate facial and truncal acne vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trifarotene Cream | Experimental | Drug: TrifaroteneParticipants will apply Trifarotene 50 mcg/g cream once daily (QD) in the evening for 12 weeks. |
| Vehicle Cream | Active comparator | Drug: Vehicle CreamParticipants will apply Vehicle cream QD in the evening for 12 weeks. |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female Chinese participants aged 9 years or older at the screening visit.
- A minimum of 20 inflammatory lesions and 25 non-inflammatory lesions on the face at Screening and Baseline.
- Facial acne vulgaris severity grade 3 (moderate) on the IGA scale at Screening and Baseline.
- A minimum of 20 inflammatory lesions and 20 non-inflammatory lesions but no more than 100 non-inflammatory lesion counts on the trunk (shoulders, upper back, and upper anterior chest) reachable for self-application of investigational product by the participant at Screening and Baseline (optional criterion for participant between 9 and 11 years of age).
- Acne vulgaris severity grade 3 (moderate) on the PGA scale at Screening and Baseline visits on trunk (shoulders, upper back and upper anterior chest) reachable for self-application of investigational product by the participant (optional criterion for participants between 9 and 11 years of age).
Key exclusion criteria (25 listed)
- Participants meeting the following criteria at the screening or baseline visits are ineligible to participate in this study:
- Pregnant women (positive serum pregnancy test result at the screening visit or positive UPT at the baseline visit), breastfeeding women, or women planning a pregnancy during the study or within 1 month after the last investigational product application.
- Severe forms of acne (e.g., acne conglobata, acne fulminans) or secondary acne form (e.g., chloracne, drug-induced acne) at the screening and baseline visits.
- More than 1 nodule on the face at the screening and baseline visits.
- More than 1 nodule on the trunk at the screening and baseline visits.
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 |
|---|---|---|
| TrifaroteneAlso: CD5789Trifarotene cream applied QD topically. | Drug | Trifarotene Cream |
| Vehicle CreamVehicle cream applied QD topically. | Drug | Vehicle Cream |
Primary outcome
Percentage of Participants with Investigator Global Assessment (IGA) Success (Face only) at Week 12
Time frame: Baseline to Week 12
The areas defined for IGA assessment are the forehead, each cheek, chin, and nose. IGA will be confined to a global assessment of each area defined above. IGA consists of 5 grades ranging from 0-4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Success Rate, defined as the percentage of participants who achieve an IGA score (face only) of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12.
Change from Baseline to Week 12 in Facial Non-inflammatory Lesion Count
Time frame: Baseline to Week 12
Change from Baseline to Week 12 in Facial Inflammatory Lesion Count
Time frame: Baseline to Week 12
6 secondary outcomes
Percentage of Participants with Physician Global Assessment (PGA) Success at Week 12
Time frame: Baseline to Week 12
Change from Baseline to Week 12 in Truncal Non-inflammatory Lesion Count
Time frame: Baseline to Week 12
Change from Baseline to Week 12 in Truncal Inflammatory Lesion Count
Time frame: Baseline to Week 12
Number of Participants With Adverse Events (AEs), Including AEs of Special Interest (AESIs), Treatment-emergent AEs (TEAEs), and Serious AEs (SAEs)
Time frame: Baseline to Week 12
Investigator's Local Tolerability Assessment
Time frame: Baseline, Weeks 1, 2, 4, 8 and 12
Observed Plasma Concentration (Ct) in Selected Participants
Time frame: Baseline, Week 4 and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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 3 study testing Trifarotene in people with Acne Vulgaris, run by Galderma R&D 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 16 inclusion and 25 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of Participants with Investigator Global Assessment (IGA) Success (Face only) at Week 12 (time frame: Baseline to Week 12). 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 24 Aug 2026.