A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris (AKLIEF)

Galderma

Status and phase: Enrolling; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: Vehicle Cream; Drug: Trifarotene

Study type: Interventional

Funder types: Industry

Identifiers

NCT07186413

CD5789.SPR.205101

Details and patient eligibility

About

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.

Enrollment: 561 estimated patients

Sex: All

Ages: 9+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Participants must meet the following criteria to be included in the study:

1. Male or female Chinese participants aged 9 years or older at the screening visit.

2. A minimum of 20 inflammatory lesions and 25 non-inflammatory lesions on the face at Screening and Baseline.

3. Facial acne vulgaris severity grade 3 (moderate) on the IGA scale at Screening and Baseline.

4. 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).

5. 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).

6. 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.

7. 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.

8. 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.

9. Willing and able to comply with all the time commitments and procedural requirements of the clinical study protocol.

10. Understands and signs an informed consent form (ICF) at the screening visit, before any investigational procedures are performed.

11. 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.

12. 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.

13. 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.

Exclusion criteria

Participants meeting the following criteria at the screening or baseline visits are ineligible to participate in this study:

1. 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.
2. 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.
3. More than 1 nodule on the face at the screening and baseline visits.
4. More than 1 nodule on the trunk at the screening and baseline visits.
5. Any acne cyst on the face at the screening and baseline visits.
6. Any acne cyst on the trunk at the screening and baseline visits.
7. Facial or truncal hair that may interfere with the study assessments according to investigator's judgment.
8. 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.
9. 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.
10. 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])).
11. 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).
12. Previously participated in any trifarotene cream clinical study.
13. Current participation in any other clinical study of a drug or device OR past participation within 30 days before the baseline visit.
14. Alcohol or drug abuse or substance dependence within 12 months before the screening visit.
15. Inability or unwillingness to undergo multiple venipunctures because of poor tolerability or venous access.
16. Loss of over 500 mL of blood or blood donation within the last 3 months before the screening visit.
17. Having received prohibited medication or treatment during the study.
18. Exposure to excessive ultraviolet (UV) radiation within 1 month before the baseline visit.
19. 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.
20. 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.
21. Unwillingness to refrain from prohibited medication during the clinical study as defined by protocol.
22. 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).
23. More than 1 participant sharing the same household.
24. 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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561 participants in 2 patient groups

Trifarotene Cream

Experimental group

Description:

Participants will apply Trifarotene 50 mcg/g cream once daily (QD) in the evening for 12 weeks.

Treatment:

Drug: Trifarotene

Vehicle Cream

Active Comparator group

Description:

Participants will apply Vehicle cream QD in the evening for 12 weeks.

Treatment:

Drug: Vehicle Cream