Study Comparing Trifarotene Cream, 0.005% To AKLIEF ® (Trifarotene 0.005% Cream) In The Treatment Of Acne Vulgaris

NCT05550337 | Completed Phase 3 Results FDA Drug

• 1 other identifier: TRIF-2101
• Study Type: interventional
• Target: 807
• Locations: 1 country
• Sites: 14

Brief Summary

To compare the safety and efficacy of the test (Trifarotene 0.005% cream), placebo (vehicle cream) and reference AKLIEF® (Trifarotene 0.005% cream) treatments to demonstrate clinical equivalence in subjects with acne vulgaris.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• Primary Change in Inflammatory Lesion Counts

  Mean percent change from screening/baseline to week 12 in the inflammatory (papules and pustules) lesion counts

  Baseline and 12 Weeks

• Primary Change in Non-Inflammatory Lesion Count

  Mean percent change from screening/baseline to week 12 in the noninflammatory (open and closed comedones) lesion counts.

  Baseline and 12 Weeks

Study Arms (3)

Test: Trifarotene Cream, 0.005%

EXPERIMENTAL

Trifarotene Cream, 0.005%, Apply to the affected areas of the face once daily for 84 days.

Drug: Trifarotene 0.005 % Topical Cream

AKLIEF®

ACTIVE COMPARATOR

AKLIEF® (Trifarotene Cream, 0.005%), Apply to the affected areas of the face once daily for 84 days.

Drug: AKLIEF®

Vehicle Product

PLACEBO COMPARATOR

Vehicle of the Test Product, Cream, Apply to the affected areas of the face once daily for 84 days.

Drug: Placebo

Interventions

Trifarotene 0.005 % Topical Cream DRUG

Cream

Test: Trifarotene Cream, 0.005%

AKLIEF® DRUG

Cream

Also known as: Trifarotene 0.005 % Topical Cream

AKLIEF®

Placebo DRUG

Cream

Also known as: Vehicle of Test Product

Vehicle Product

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or non-pregnant, non-lactating female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
• Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB/IEC approved written informed consent. Subjects 12 to 17 years of age inclusive must have provided IRB/IEC approved written assent; this written assent must be accompanied by an IRB/IEC approved written informed consent from the Subject's legally acceptable representative (i.e., parent or guardian). In addition, all Subjects or their legally acceptable representatives (i.e., parent or guardian) must sign a HIPAA authorization.
• Subjects must have ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤ 2 nodulocystic lesions (i.e.,nodules and cysts), at screening/baseline on the face.
• (a) For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area. All lesions will be counted, including those present on the nose. Subjects may have acne lesions on other areas of the body which will be excluded from the count and the Investigator's Global Assessment (IGA) evaluation (e.g., on the back, chest and arms).
• Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA) (per Table 1 below) at screening/baseline. Acne vulgaris should be stable (for at least 3 months prior to screening), with minimal variation from day to day and within each day, in the opinion of the subject.
• Table 1: Investigator's Global Assessment (IGA) Scale for Acne Vulgaris Grade Description 0 Clear skin with no inflammatory or non-inflammatory lesions 1 Almost clear; rare non-inflammatory lesions with no more than one small inflammatory lesion 2 Mild severity; greater than Grade 1; some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions) 3 Moderate severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion 4\* Severe; greater than Grade 3; up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than a few nodular lesions
• \* The eCRF will allow for reporting by Investigators of lesion worsening beyond Grade 4 with treatment. Acne vulgaris subjects with nodulocystic acne are not to be enrolled in the study.
• Subjects who worsen beyond Grade 4 will be described in the safety evaluation. Note: Counts of nodules and cysts will be reported separately and not included in the inflammatory or non-inflammatory lesion counts.
• Subjects must be willing to refrain from using all other topical acne medications or antibiotics during the 12-week treatment period, other than the investigational product.
• Female subjects of childbearing potential (\*WOCBP) must not be pregnant or lactating at the time of screening/baseline visit as documented by a negative urine pregnancy test with a sensitivity to at least 25 mIU/ml hCG .
• \*Female subjects of childbearing potential (WOCBP) are defined as sexually mature women without prior hysterectomy, or who have had any evidence of menses in the past 12 months.
• However, women who have been amenorrheic for the past 12 or more months are still considered to be of childbearing potential, if the amenorrhea is possibly due to other causes, including prior chemotherapy, anti- estrogens, or ovarian suppression. Postmenopausal women (defined as women who have been amenorrheic for at least 12 consecutive months, in the appropriate age group, without other known or suspected primary cause) or women who have been sterilized surgically or who are otherwise proven sterile (i.e., total hysterectomy, or bilateral oophorectomy with surgery at least 4 weeks prior to randomization) are not considered WOCBP. Subjects who have undergone tubal ligation are NOT considered as surgically sterile.
• Female subjects of childbearing potential must be willing to use an acceptable form of birth control during the study from the day of the first dose administration to 30 days after the last administration of study drug.
• For the purposes of this study the following are considered acceptable methods of birth control: oral or injectable contraceptives, contraceptive patches, medroxyprogesterone acetate (ex. Depo-Provera®) with stabilized use for at least 3 months, vaginal contraceptive (ex. etonogestrel/ethinyl estradiol vaginal ring (ex. NuvaRing®), contraceptive implant with etonogestrel or equivalent, double barrier methods, (e.g.
• condom and spermicide), intrauterine device (IUD), true abstinence (if in line with subject's lifestyle).

You may not qualify if:

• Female subjects who are pregnant, lactating or planning to become pregnant during study participation.
• Subjects with a history of hypersensitivity or allergy to trifarotene, tretinoin, retinoids, or any of the study medication ingredients.
• Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (such conditions include but are not limited to the following on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid or corticosteroid-induced acne, steroid folliculitis, or bacterial folliculitis, auto-immune disease, perioral dermatitis, carcinoid syndrome, mastocytosis, acneiform eruptions caused by make-up and medication, facial psoriasis and facial eczema).
• Subjects with nodulocystic acne (\> 2 nodules and cysts). \[Nodules or cysts defined as; deepseated in the skin (i.e., centered in the dermis or subcutis) and an inflammatory lesion greater than or equal to 5 mm in diameter\], acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.) or acne vulgaris requiring systemic treatment.
• Subjects with excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
• Subjects with tattoos or excessive facial scarring that, in the Investigator's opinion, may interfere with the evaluation of the patient's acne.
• Subjects who have used within 6 months prior to screening/baseline oral retinoids (e.g., Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed). These treatments with oral retinoids or Vitamin A supplements are prohibited during the study participation.
• Subjects who have used within 1 month prior to screening/baseline neuromuscular blocking agents or androgen receptor blockers (e.g., spironolactone, Flutamide etc.).
• Subjects who have had laser therapy, electrodessication phototherapy and or cosmetic procedures (e.g., ClearLight ® BOTOX, Filler, micro needling) to the facial area within 6 months prior to study entry.
• Subjects who have had facial cosmetic procedures (e.g., facials) or application of cosmetic products (cosmetics, makeup or facial products that have a strong drying or possible interactive effect, particularly preparations containing spices, lime sulfur, resorcinol, or salicylic acid with tretinoin or other retinoids) which may affect the efficacy and safety profile of the investigational product within 2 weeks prior to study entry.
• Subjects who have received radiation therapy and/or anti-neoplastic agents within 3 months prior to screening/baseline.
• Subjects who have used for less than (\<) 3 months prior to screening/baseline estrogens or oral contraceptives; use of such therapy must remain constant throughout the study.
• Subjects who have used any of the following procedures on the face within 1 month prior to screening/baseline or use during the study:
• cryodestruction or chemodestruction,
• dermabrasion,

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead
• Teva Pharmaceuticals, Inc.: collaborator

Study Sites (14)

Site 10011

West Covina, California, 91790, United States

Location

Site 10001

Brandon, Florida, 33511, United States

Location

Site 10003

Fort Lauderdale, Florida, 33308, United States

Location

Site 10004

Miami, Florida, 33175, United States

Location

Site 10005

Miramar, Florida, 33027, United States

Location

Site 10002

Tampa, Florida, 33609, United States

Location

Site 10012

Baton Rouge, Louisiana, 70809, United States

Location

Site 10013

Baton Rouge, Louisiana, 70809, United States

Location

Site 10011

New Orleans, Louisiana, 70115, United States

Location

Site 10008

Las Cruces, New Mexico, 88011, United States

Location

Site 10010

Saint Clair, Pennsylvania, 15241, United States

Location

Site 10009

Dallas, Texas, 75234, United States

Location

Site 10006

El Paso, Texas, 79902, United States

Location

Site 10007

El Paso, Texas, 79925, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

trifarotene

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Director, PD/CE Studies
• Organization: Teva Pharmaceuticals, Inc.

usmedinfo@tevapharm.com

1-888-483-8279

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 22, 2022
• Study Start: September 19, 2022
• Primary Completion: May 9, 2023
• Study Completion: May 9, 2023
• Last Updated: September 26, 2024
• Results First Posted: September 26, 2024

Record last verified: 2024-09

Locations

US (14)