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Compares treatment options for Acne Vulgaris
Official title A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris
ClinicalTrials.gov ID: NCT07186413
What this study is testing
What is Trifarotene?
Trifarotene is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for acne vulgaris.
Also referred to as CD5789.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 9 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- Severe forms of acne (e.g., acne conglobata, acne fulminans) or secondary acne form (e.g., chloracne, drug-induced acne) at the screening and...
- 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.
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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...
- 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...
- 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.
What rules you out
- 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...
- 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.
- 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...
- 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...
- 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 side effects 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Jing'an District, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 9 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Jing'an District, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.