AKLIEF® (trifarotene) Cream, 0.005%

BRINGS RAPID RESULTS* AND POWERFUL EFFICACY.1

*Indicating a 2-week time frame until results on the face; a 4-week time frame until results on the trunk.1

PIVOTAL Studies 1 & 2

FIRST LARGE-SCALE CLINICAL TRIALS.1

PIVOTAL Studies 1 & 2 were the first large-scale, randomized, Phase 3 clinical trials to simultaneously evaluate a topical therapy for the treatment of both moderate facial and truncal acne vulgaris.1

Study Design

2,420

PATIENTS RANDOMIZED 1:1

From sites across US, Canada, Europe, and Russia
Mean age: 19 years (9-58 years); AKLIEF Cream once daily

AKLIEF Cream

n=1,214

VEHICLE

n=1,206

PIVOTAL Studies 1 & 2

PRIMARY ENDPOINTS:
FACE1

  • Success rate: Percentage of subjects with IGA* of clear (0) or almost clear (1) and at least a 2-grade improvement from baseline to Week 12
  • Absolute change in facial inflammatory and non-inflammatory lesion count from baseline to Week 12

*The definitions of severity for the 5-point IGA and PGA scales were the same: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe).

IGA=Investigator’s Global Assessment.

PIVOTAL Studies 1 & 2

SECONDARY ENDPOINTS:
TRUNK1

  • Success rate: Percentage of subjects with PGA* of clear (0) or almost clear (1) and at least a 2-grade improvement from baseline to Week 12
  • Absolute change in truncal inflammatory and non-inflammatory lesion count from baseline to Week 12

*The definitions of severity for the 5-point IGA and PGA scales were the same: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe).

PGA=Physician’s Global Assessment.

PIVOTAL Studies 1 & 2

SAFETY ENDPOINTS1

  • Incidence of adverse events
  • Local tolerability (erythema, scaling, dryness, stinging, burning)
 

AKLIEF Cream

PROVEN TO REDUCE INFLAMMATORY LESIONS OF ACNE.1

In AKLIEF Cream PIVOTAL Study 1, significant improvement seen as early as Week 2.1

AKLIEF Cream

PROVEN TO REDUCE INFLAMMATORY LESIONS OF ACNE.1

In AKLIEF Cream PIVOTAL Study 1, significant improvement seen as early as Week 4.1

 

SAFE AND WELL-TOLERATED ON BOTH THE FACE AND TRUNK.1

PIVOTAL STUDY 1: TOLERABILITY SIGNS AND SYMPTOMS*

Local irritation was transient, peaking at Week 1 on the face and Weeks 2-4 on the trunk and decreased thereafter.1

Most common adverse reactions (incidence ≥ 1%) in patients treated with AKLIEF Cream were application site irritation, application site pruritus (itching), and sunburn.

*Local tolerability signs and symptoms were evaluated on a 4-point severity scale: 0 (none), 1 (mild), 2 (moderate), and 3 (severe) from baseline to Week 12.

SAFE AND WELL-TOLERATED ON BOTH THE FACE AND TRUNK.1

PIVOTAL STUDY 1: TOLERABILITY SIGNS AND SYMPTOMS*

Local irritation was transient, peaking at Week 1 on the face and Weeks 2-4 on the trunk and decreased thereafter.1

Most common adverse reactions (incidence ≥ 1%) in patients treated with AKLIEF Cream were application site irritation, application site pruritus (itching), and sunburn.

*Local tolerability signs and symptoms were evaluated on a 4-point severity scale: 0 (none), 1 (mild), 2 (moderate), and 3 (severe) from baseline to Week 12.

 

In a long-term safety study,

WELL-TOLERATED THROUGHOUT THE STUDY AT 1 YEAR.2*

SATISFY Study: A multicenter, open-label study of 455 patients with moderate facial and truncal acne assessing the long-term safety (primary endpoint), efficacy, and quality of life (secondary endpoints) of AKLIEF Cream over 52 weeks.

As observed with other retinoids, the majority of local adverse events occurred during the first weeks of treatment, subsiding thereafter.2

*Local tolerability signs and symptoms were evaluated on a 4-point severity scale: 0 (none), 1 (mild), 2 (moderate), and 3 (severe) from baseline to Week 52.

In a long-term safety study,

WELL-TOLERATED THROUGHOUT THE STUDY AT 1 YEAR.2*

SATISFY Study: A multicenter, open-label study of 455 patients with moderate facial and truncal acne assessing the long-term safety (primary endpoint), efficacy, and quality of life (secondary endpoints) of AKLIEF Cream over 52 weeks.

As observed with other retinoids, the majority of local adverse events occurred during the first weeks of treatment, subsiding thereafter.2

*Local tolerability signs and symptoms were evaluated on a 4-point severity scale: 0 (none), 1 (mild), 2 (moderate), and 3 (severe) from baseline to Week 52.

 

References: 1. Tan J, Thiboutot D, Popp G, et al. Randomized phase 3 evaluation of trifarotene 50 µg/g cream treatment of moderate facial and truncal acne. J Am Acad Dermatol. 2019;80(6):1691-1699. 2. Blume-Peytavi U, Fowler J, Kemény L, et al. Long-term safety and efficacy of trifarotene 50 µg/g cream, a first-in-class RAR-γ selective topical retinoid, in patients with moderate facial and truncal acne. J Eur Acad Dermatol Venereol. 2019. doi: 10.1111/jdv.15794.

IMPORTANT SAFETY INFORMATION

Indication: AKLIEF® (trifarotene) Cream, 0.005% is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in patients treated with AKLIEF Cream were application site irritation, application site pruritus (itching), and sunburn. Warnings/Precautions: Patients using AKLIEF Cream may experience erythema, scaling, dryness, and stinging/burning. Use a moisturizer from the initiation of treatment, and, if appropriate, depending upon the severity of these adverse reactions, reduce the frequency of application of AKLIEF Cream, suspend or discontinue use. 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. Minimize exposure to sunlight and sunlamps. Use sunscreen and protective clothing over treated areas when exposure cannot be avoided.

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Indication: AKLIEF® (trifarotene) Cream, 0.005% is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in patients treated with AKLIEF Cream were application site irritation, application site pruritus (itching), and sunburn. Please see full Important Safety Information below.

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