AKLIEF® (trifarotene)
Cream, 0.005%:

PROVEN EFFICACY IN PATIENTS WITH ACNE.1

Not an actual patient.

AKLIEF® PIVOTAL Studies 1 & 2

First large scale trials to investigate truncal acne.1,2

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 daily1

AKLIEF Cream

n=1,214

VEHICLE

n=1,206

Figure outline represents AKLIEF® (trifarotene) Cream pivotal studies 1 & 2 on facial acne vulgaris

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

SAFETY ENDPOINTS1

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

*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.

Truncal figure outline represents AKLIEF® (trifarotene) Cream pivotal studies 1 & 2 on truncal acne vulgaris

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 Global Assessment.

 

AKLIEF Cream

THE FIRST TOPICAL ACNE TREATMENT WITH PROVEN RESULTS ON THE FACE AND TRUNK.2

AKLIEF® (trifarotene) Cream PIVOTAL Study 1 chart shows facial lesions reduction over 12 weeks. Significant improvements wk 2

PIVOTAL Primary endpoints: 1) Absolute change in facial inflammatory and non-inflammatory lesion counts from baseline to Week 12; 2) Investigator's Global Assessment (IGA) success rate on the face.1

AKLIEF® (trifarotene) Cream PIVOTAL Study 2 chart shows facial lesions reduction over 12 weeks. Significant improvements wk 2

PIVOTAL Primary endpoints: 1) Absolute change in facial inflammatory and non-inflammatory lesion counts from baseline to Week 12; 2) Investigator’s Global Assessment (IGA) success rate on the face.1

AKLIEF Cream

THE FIRST TOPICAL ACNE TREATMENT WITH PROVEN RESULTS ON THE FACE AND TRUNK.2

AKLIEF® (trifarotene) Cream PIVOTAL Study 1 chart shows truncal lesion reduction over 12 weeks. Significant improvements wk 4

PIVOTAL Secondary endpoints: 1) Absolute change in truncal inflammatory and non-inflammatory lesion counts from baseline at Week 12; 2) Physician's Global Assessment (PGA) success rate on the trunk.1

AKLIEF® (trifarotene) Cream PIVOTAL Study 2 chart shows truncal lesion reduction over 12 weeks. Significant improvements wk 4

PIVOTAL Secondary endpoints: 1) Absolute change in truncal inflammatory and non-inflammatory lesion counts from baseline at Week 12; 2) Physician's Global Assessment (PGA) success rate on the trunk.

 

SAFE AND WELL-TOLERATED ON BOTH THE FACE AND TRUNK AT WEEK 12.1

PIVOTAL STUDY 1: TOLERABILITY SIGNS AND SYMPTOMS

AKLIEF® (trifarotene) Cream PIVOTAL Study 1 chart shows facial tolerability signs & symptoms over 12 weeks
  • Mean tolerability scores for erythema, scaling, dryness, and stinging/burning peaked at Week 1 on the face and decreased thereafter1
  • 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—all scores stayed below 1 through Week 121

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

PIVOTAL STUDY 1: TOLERABILITY SIGNS AND SYMPTOMS

AKLIEF® (trifarotene) Cream PIVOTAL Study 1 chart shows truncal tolerability signs & symptoms over 12 weeks
  • Mean tolerability scores for erythema, scaling, dryness, and stinging/burning peaked at Week 1 on the face and decreased thereafter1
  • 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—all scores stayed below 1 through Week 121
 

In a long-term safety study,

WELL-TOLERATED THROUGHOUT THE STUDY AT 52 WEEKS.5

SATISFY Study: A multicenter, open-label study of 453 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.

PIVOTAL STUDY 1: TOLERABILITY SIGNS AND SYMPTOMS

AKLIEF® (trifarotene) Cream PIVOTAL Study 1 long term SATISFY Study shows facial tolerability signs & symptoms over 52 weeks
  • Mean tolerability scores for erythema, scaling, dryness, and stinging/burning peaked at Week 1 on the face and decreased thereafter5
  • 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—all scores stayed below 1 through Week 525

In a long-term safety study,

WELL-TOLERATED THROUGHOUT THE STUDY AT 52 WEEKS.5

SATISFY Study: A multicenter, open-label study of 453 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.

PIVOTAL STUDY 1: TOLERABILITY SIGNS AND SYMPTOMS

AKLIEF® (trifarotene) Cream PIVOTAL Study 1 long term SATISFY Study shows truncal tolerability signs & symptoms over 52 weeks
  • Mean tolerability scores for erythema, scaling, dryness, and stinging/burning peaked at Week 1 on the face and decreased thereafter5
  • 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—all scores stayed below 1 through Week 525

Study Design

DUAL STUDY

A multicenter, randomized, double-blind Phase 4 clinical trial to evaluate the efficacy and safety of AKLIEF® (trifarotene) Cream, 0.005% with oral doxycycline once daily vs vehicle with doxycycline placebo in severe facial acne vulgaris.6

Study Design

202

PATIENTS COMBINED RANDOMIZED 2:1

from sites across US, Puerto Rico Trifarotene topical acne daily; 120 mg enteric coated oral doxycycline (MPC) once daily6

AKLIEF Cream + Doxycycline

n=133

VEHICLE +
Placebo

n=69

PRIMARY ENDPOINT6

  • Absolute change in total facial lesions from baseline to Week 12

SAFETY ENDPOINTS6

  • Local tolerability (erythema, scaling, dryness, stinging/burning)
  • Incidence of treatment-emergent adverse event

*The definitions of severity for the 5-point IGA (face) scale are: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe).6

THE DUAL STUDY SHOWED SIGNIFICANT RESULTS FOR PATIENTS WITH SEVERE ACNE.6

Phase 4 study of AKLIEF® (trifarotene) Cream, 0.005% with 120 mg enteric coated oral doxycycline in a population with severe acne.6

AKLIEF® (trifarotene) Cream Dual Study with doxycycline: facial lesions reduction over 12 wks. Significant improvements wk 4

Figure is based on observed case analysis. Results of MI statistical analysis at Week 12 are included. For percent change in total lesion count from baseline (MI), the difference between treatment groups [95% CI] was -8.6 [-16.5, -0.7] at Week 4 (P=0.0334), -12.1 [-20.0, -4.2] at Week 8 (P=0.0028) and -21.5 [-28.9, -14.1] at Week 12 (P<0.0001).

CI=confidence interval; MI=multiple imputation statistical modeling.6

SAFE AND WELL-TOLERATED FOR PATIENTS WITH SEVERE ACNE.6

Phase 4 study of AKLIEF® (trifarotene) Cream, 0.005% with 120 mg enteric coated oral doxycycline in a population with severe acne.6

Local irritation was

MILD & TRANSIENT

AT WEEK 1 AND REDUCED THEREAFTER6

  • The most common adverse reactions (incidence ≥ 1%) in patients treated with AKLIEF Cream were application site pruritus (itching) and sunburn6
  • AKLIEF Cream and enteric coated oral doxycycline 120 mg was well tolerated, with tolerability comparable to placebo6
    • The incidence of treatment-emergent adverse events was low6

SECONDARY ENDPOINTS6

  • Investigator's Global Assessment (IGA)* facial success rate at Week 12, defined as BOTH IGA 0 (clear) or 1 (almost clear) AND ≥2-grade IGA improvement
  • Percentage change in facial inflammatory and non-inflammatory lesions from baseline to Week 12

SAFETY ENDPOINTS6

  • Local tolerability (erythema, scaling, dryness, stinging/burning)
  • Incidence of treatment-emergent adverse event

*The definitions of severity for the 5-point IGA (face) scale is: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe).6

DOUBLE THE IGA SUCCESS RATE AT WEEK 12 VS VEHICLE.6

Phase 4 study of AKLIEF® (trifarotene) Cream, 0.005% with 120 mg enteric coated oral doxycycline in a population with severe acne.6

Figure is based on observed case analysis. Results of statistical analysis at Week 12 are included. IGA success is defined as IGA score 0 (clear) or 1 (almost clear), and at least a 2-grade improvement from baseline. (31.7 vs 15.8; P=0.0107; MI).

IGA=Investigator's Global Assessment; ITT=intent to treat; MI=multiple imputation.6

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. AKLIEF Press Release. Federal Drug Administration approval 2019. 3. Data on File, Galderma Laboratories, L.P. 4. Data on File, Galderma Laboratories, L.P. 5. 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. 2020;34(1):166-173. 6. Data on File, Galderma Laboratories, L.P.

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.

 

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