Trifarotene

Trifarotene is an agonist of retinoic acid receptors (RAR), with particular activity at the gamma subtype of RAR. Stimulation of RAR results in modulation of target genes which are associated with various processes, including cell differentiation and mediation of inflammation.

• AKLIEF Cream is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. AKLIEF Cream is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.ICD-10: L70.0

• None None ( 4 )contraindicated

Apply a thin layer of AKLIEF Cream to the affected areas once daily, in the evening, on clean and dry skin. One pump actuation should be enough to cover the face (i.e., forehead, cheeks, nose, and chin). Two actuations of the pump should be enough to cover the upper trunk (i.e., reachable upper back, shoulders and chest). One additional pump actuation may be used for middle and lower back if acne is present. The use of a moisturizer is recommended as frequently as needed from the initiation of treatment. Avoid contact with the eyes, lips, paranasal creases, mucous membranes. AKLIEF Cream is for topical use only. Not for oral, ophthalmic, or intravaginal use. For topical use only. Not for oral, ophthalmic or intravaginal use. Apply a thin layer of AKLIEF Cream to the affected areas of the face and/or trunk once a day, in the evening, on clean and dry skin. Avoid contact with the eyes, lips, paranasal creases, and mucous membranes. ( 2 )

Skin irritation: Erythema, scaling, dryness, and stinging/burning may be experienced with use of AKLIEF Cream. Use a moisturizer from the initiation of treatment, and, if appropriate, reduce the frequency of application of AKLIEF Cream, suspend or discontinue use. ( 5.1 ) Ultraviolet Light and Environmental Exposure: Minimize exposure to sunlight and sunlamps. Use sunscreen and protective clothing over treated areas when exposure cannot be avoided. ( 5.2 ) 5.1 Skin Irritation Patients using AKLIEF Cream may experience erythema, scaling, dryness, and stinging/burning. Maximum severity of these reactions typically occurred within the first 4 weeks of treatment, and severity decreased with continued use of the medication. Depending upon the severity of these adverse reactions, instruct patients to use a moisturizer, reduce the frequency of application of AKLIEF Cream, or suspend use temporarily. If severe reactions persist the treatment may be discontinued. Avoid application of AKLIEF Cream to cuts, abrasions, or eczematous or sunburned skin. Use of “waxing” as a depilatory method should be avoided on skin treated with AKLIEF Cream. 5.2 Ultraviolet Light and Environmental Exposure Minimize unprotected exposure to ultraviolet rays (including sunlight and sunlamps) during treatment with AKLIEF Cream. Warn patients who normally experience high levels of sun exposure and those with inherent sensitivity to sun to exercise caution. Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided.

Most common adverse reactions (incidence ≥ 1%) in patients treated with AKLIEF Cream were application site irritation, application site pruritus, and sunburn ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical trials experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect rates observed in practice. In the three Phase 3 clinical trials, 1673 subjects with acne vulgaris on the face and trunk, 9 years and older were exposed to AKLIEF Cream. Of these, 1220 subjects were treated once daily for up to 12 weeks and 453 were treated once daily for up to 1 year. Adverse reactions reported in the 2 randomized, double-blind, vehicle-controlled 12-week clinical trials in ≥ 1.0% of subjects treated with AKLIEF Cream (and for which the rate exceeded the rate for vehicle), as well as the corresponding rates reported in subjects treated with the vehicle cream are presented in Table 1. Table 1.

8.1 Pregnancy Risk Summary Available data from clinical trials with AKLIEF Cream use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are case reports of major birth defects similar to those seen in fetuses exposed to oral retinoids in pregnant women exposed to other topical retinoids, but these case reports do not establish a pattern or association with retinoid-related embryopathy. In animal reproduction studies, oral doses of trifarotene administered to pregnant rats and rabbits during organogenesis that resulted in systemic exposures more than 800 times the systemic exposure at the maximum recommended human dose (MRHD) of AKLIEF Cream resulted in adverse fetal effects, including fetal deaths and external, visceral, and skeletal malformations (see Data) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Metabolism

Pharmacokinetics of trifarotene was evaluated in a study involving 19 adult subjects with acne vulgaris following once daily application of AKLIEF Cream for 29 days (daily dose range 1.5 g/day to 2 g/day) to the face, shoulders, chest and upper back. Absorption: Systemic concentrations were at steady state following 2 weeks of treatment and were quantifiable in 7 subjects.

• Oct 4, 2019NDANDA211527Galderma Labs Lp

1. 1Erythema2816%
2. 2Acne179.9%
3. 3Skin Burning Sensation179.9%
4. 4Urinary Retention169.3%
5. 5Dry Skin158.7%
6. 6Mydriasis158.7%
7. 7Skin Exfoliation148.1%
8. 8Skin Irritation137.6%
9. 9Drug Ineffective105.8%
10. 10Vision Blurred105.8%
11. 11Product Use In Unapproved Indication95.2%
12. 12Skin Hyperpigmentation95.2%
13. 13Off Label Use84.7%
14. 14Intentional Underdose74.1%
15. 15Pain Of Skin74.1%

The 10 most recently updated of 14 ClinicalTrials.gov registrations naming Trifarotene as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris
  Recruiting · Phase 3 · Interventional · 561 enrolled · Galderma R&D
  NCT07186413updated 2025-11-21
• A Study Comparing Trifarotene Cream 0.005% to AKLIEF® CREAM (US REFERENCE LISTED DRUG), AKLIEF™ CREAM (CANADIAN REFERENCE PRODUCT) in the Treatment of Acne Vulgaris
  Completed · Phase 1 · Interventional · 1,000 enrolled · Sun Pharmaceutical Industries, Inc.
  NCT06733402updated 2024-12-13
• Study Comparing Trifarotene Cream, 0.005% To AKLIEF ® (Trifarotene 0.005% Cream) In The Treatment Of Acne Vulgaris
  Completed · Phase 3 · Interventional · 807 enrolled · Teva Pharmaceuticals USA
  NCT05550337updated 2024-09-26
• Study of Trifarotene Cream to Assess Risk of a Trophic Acne Scar Formation
  Completed · Phase 4 · Interventional · 121 enrolled · Galderma R&D
  NCT04856904updated 2024-06-11
• AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation
  Completed · Phase 4 · Interventional · 123 enrolled · Galderma R&D
  NCT05089708updated 2023-12-20
• A Study Comparing Trifarotene Cream 0.005% to AKLIEF® Cream in the Treatment of Acne Vulgaris
  Completed · Phase 1 · Interventional · 762 enrolled · Sun Pharmaceutical Industries, Inc.
  NCT06063473updated 2023-10-02
• A Safety, Efficacy and Systemic Exposure Study of CD5789 Cream in Adults and Adolescents With Lamellar Ichthyosis
  Terminated · Phase 2 · Interventional · 65 enrolled · Mayne Pharma International Pty Ltd
  NCT03738800updated 2023-08-14
• A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV)
  Completed · Phase 4 · Interventional · 202 enrolled · Galderma R&D
  NCT04451330updated 2022-05-10
• Participant Reported Outcomes With Use of Trifarotene 50 μg/g Cream in the Treatment of Moderate Facial and Truncal Acne Vulgaris
  Completed · Phase 3 · Interventional · 47 enrolled · Galderma R&D
  NCT03915860updated 2021-12-15
• Dose Range Study of CD5789 in Acne Vulgaris
  Completed · Phase 2 · Interventional · 304 enrolled · Galderma R&D
  NCT01616654updated 2021-09-20

Frequently asked questions

How does Trifarotene work?

Trifarotene is an agonist of retinoic acid receptors (RAR), with particular activity at the gamma subtype of RAR. Stimulation of RAR results in modulation of target genes which are associated with various processes, including cell differentiation and mediation of inflammation.

What is Trifarotene used for?

According to FDA labeling, Trifarotene carries indications including: AKLIEF Cream is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. AKLIEF Cream is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Trifarotene?

Trifarotene is classified as Retinoids for topical use in acne, Retinoid, Receptor Interactions, Unknown Cellular or Molecular Interaction.

What are the brand names for Trifarotene?

Trifarotene is marketed under brand names including Aklief.

What are the contraindications for Trifarotene?

Trifarotene labeling lists contraindications including: None None ( 4 ). Always consult the full prescribing information and a clinician.