ACKNOWLEDGEMENTS Study funded by Galderma R&D, LLC. Medical writing supported by Galderma Laboratories, L.P.  ALT.P-RD18250-08

INTRODUCTION
Introduction to trifarotene 50 μg/g cream:1

• Retinoid receptor agonist that selectively targets retinoic acid receptor gamma
• Low systemic exposure after topical administration
• Once-daily cream developed for treatment of acne vulgaris on the face and trunk
Objectives:
• Study 1 and Study 2: Assess safety and efficacy of trifarotene 50 μg/g cream applied once daily for 12 weeks in subjects with 

acne vulgaris
• Long-term Safety and Efficacy Study: Evaluate long-term safety and efficacy of trifarotene 50 μg/g cream use over a period of 

52 weeks

TRIFAROTENE 50 μg/g CREAM FOR TREATMENT OF ACNE VULGARIS – A SUMMARY OF TWO RANDOMIZED TRIALS AND A LONG-TERM SAFETY STUDY
Jerry Tan, MD1; James Del Rosso, DO2; Jonathan Weiss, MD3; Linda Stein Gold, MD4; Fran Cook-Bolden, MD5; Lawrence Eichenfield, MD6; Emil Tanghetti, MD7; Michael Graeber, MD8; Allesandra Alió Saenz, MD8; Faiz Ahmad8 

1Department of Medicine, University of Western Ontario, Windsor ON, Canada, 2JDR Dermatology Research/Thomas Dermatology, Las Vegas, NV; 3Gwinnett Dermatology, Snellville, GA; 4Henry Ford Medical Center Department of Dermatology, Detroit, MI; 5Mount Sinai Hospital, New York, NY;  
6Department of Pediatric and Adolescent Dermatology, Rady Children’s Hospital, University of California, San Diego, CA; 7Center for Dermatology and Laser Surgery Sacramento, CA; 8Galderma R&D, LLC, Fort Worth, TX

METHODS
Study 1 and 2
• Two identical multi-center, double-blind, randomized 12-week studies of subjects with moderate facial and truncal acne comparing 

vehicle with once-daily trifarotene 50 μg/g cream; N = 2,420
• Study 1: conducted at 109 sites, majority United States
• Study 2: conducted at 80 sites, majority Europe
• Primary efficacy endpoints (face) measured at Baseline and Weeks 1, 2, 4, 8, and 12: 

 - Success rate: percentage of subjects with Investigator Global Assessment (IGA) of clear (0) or almost clear (1) and at least a 
2-grade improvement 

 - Absolute change in facial inflammatory/non-inflammatory lesion count 
• Secondary efficacy endpoints (trunk) measured at Baseline and Weeks 1, 2, 4, 8, and 12: 

 - Success rate: percentage of subjects with Physician Global Assessment (PGA) of clear (0) or almost clear (1) and at least a 
2-grade improvement 

 - Absolute change in truncal inflammatory/non-inflammatory lesion count
• Safety endpoints:

 - Incidence of adverse events and local tolerability1 

Long-term Efficacy and Safety Study
•  A long-term safety and efficacy study conducted over 52 weeks for once-daily use of trifarotene 50 μg/g cream in patients with 

moderate facial and truncal acne; N = 455
• Efficacy and tolerability measured at Baseline and Weeks 12, 20, 26, 38, and 52
• Primary endpoints (safety) included:

 - Local tolerability (erythema, scaling, dryness, stinging/burning) on face and trunk
 - Adverse events

• Secondary endpoints (efficacy) included:
 - Success rate: IGA/PGA score of clear (0) or almost clear (1) and at least a 2-grade IGA/PGA improvement from Baseline
 - Grade change from baseline of IGA and PGA
 - Subject’s assessment of facial acne improvement2

RESULTS
Study 1 and 2
Efficacy:

Results of all efficacy assessments at Week 12 significant (P <.001) in favor of trifarotene 50 μg/g cream versus vehicle 
• Study 1: Primary efficacy endpoints (MI)

 - 29.4% IGA success rate in trifarotene 50 μg/g cream compared with 19.5% for vehicle 
 - Mean percent change of -54.4% in facial inflammatory lesion count from Baseline to Week 12 for trifarotene 50 μg/g cream, 

compared with -44.8% for vehicle 
 - Mean percent change of -49.7% in facial non-inflammatory lesion count from Baseline to Week 12 for trifarotene 50 μg/g 

cream, compared with -35.7% for vehicle (multiple imputation values used)
• Study 2: Primary efficacy endpoints

 - 42.3% trifarotene 50 μg/g cream IGA success rate compared with 25.7% for vehicle 
 - Mean percent change of -66.2% in facial inflammatory lesion count from Baseline to Week 12 for trifarotene 50 μg/g cream, 

compared with -51.2% for vehicle 
 - Mean percent change of -57.7% in facial non-inflammatory lesion count from Baseline to Week 12 for trifarotene 50 μg/g 

cream, compared with -43.9% for vehicle (multiple imputation values used)
Safety:
• Skin irritation related to trifarotene 50 μg/g cream was transient, and consistent with known patterns of topical retinoid dermatitis

 - Most common related AEs included irritation, pruritus, and sunburn (incidence ≥1%)
 - Severe AEs related to trifarotene 50 μg/g cream reported in nine subjects versus none in the vehicle group, with no serious AEs 

reported
 - Severe related AEs led to subject discontinuation in 1.9% of the trifarotene 50 μg/g cream group in Study 1, and in 1.2% of 

the trifarotene 50 μg/g cream group in Study 2
• Tolerability signs related to trifarotene 50 μg/g cream assessed as mostly mild to moderate by investigator

Long-term Efficacy and Safety Study
Efficacy:
• Both IGA and PGA success rates improved over time 

 - IGA success rates increased from 26.6% at Week 12 to 65.1% at Week 52
 - PGA success rates increased from 38.6% at Week 12 to 66.9% at Week 52
 - At Week 52, 57.9% of patients had both IGA and PGA success2

Safety:
• Majority of treatment emergent adverse events (TEAEs) occurred during the first three months of the study
• Most common TEAEs included pruritus, irritation, and sunburn
• No serious TEAEs were related to trifarotene 50 μg/g cream2

REFERENCES

We wish to thank our colleagues in Galderma International, Galderma R&D in Sophia Antipolis, and Galderma Laboratories and the trifarotene study 
group, as well as all investigators in the United States, Canada, Europe, and Russia who participated in these clinical trials.

1. Tan J, Thiboutot D, Popp G, Gooderham M, Lynde C, Del Rosso J, et al. Randomized phase 3 evaluation of trifarotene 50 mg/g cream treatment of 
moderate facial and truncal acne. J Am Acad Dermatol. 2019;80:1691-9.

2. Blume-Peytavi U, Fowler J, Lajos K, Draelos Z, Cook-Bolden F, Dirschka T, et al. Long-term safety and efficacy of trifarotene 50μg/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:(In preparation).

SUMMARY

• In Study 1 and Study 2, trifarotene 50 μg/g cream had a rapid effect, with  
significant reduction in lesion counts on the face as early as Week 1, and on the 
trunk as early as Week 2

• Subjects in the Long-term Safety and Efficacy Study demonstrated continuous 
clinical improvement over the course of the 52-week study period 

• Trifarotene 50 μg/g cream is well tolerated and efficacious for treatment of 
facial and truncal acne, compared with vehicle

• Treatment with trifarotene 50 μg/g cream was observed to be safe 
and tolerable in both the 12- and 52-week studies1, 2

Subject screened
N = 2817

Subject randomized
N = 2420

Screen failure
N = 397

Discontinued
N = 98

Discontinued
N = 116

R

Trifarotene 50 µg cream 
N = 1214

Completed study protocol
N = 1098

Vehicle
N = 1206

Completed study protocol
N = 1108

Study 1

Study 2

Mean age (standard deviation): 19.4 ± 6.41
Gender ratio: 52.1% female/47.9% male

Mean age (standard deviation): 19.7 ± 6.3
Gender ratio: 57.3% female/42.7% male

Figure 2. Efficacy Comparison of Trifarotene 50 μg/g Cream and Vehicle 

0.5%
1.8% 4.0%

9.5%

20.0% 19.5%

0.2%
2.2%

7.9%*

16.2%*

29.7%* 29.4%
†

0

5

10

15

20

25

30

35

40

45

50

Baseline

*P<.05; 95% CI (1.2, 6.7) ; † Treatment difference at Week 12 (95% CI) 9.9% (4.8, 14.8); P<.001

1 2 4 8 12 12 (MI)

IG
A 

Su
cce

ss
 %

Weeks

Vehicle
Trifarotene  50 µg/g

*P<.05; 95% CI (4.6, 13.7) ; † Treatment difference (95% CI) 10.7% (5.4, 16.1); P<.001

PG
A 

Su
cce

ss
 %

0

5

10

15

20

25

30

35

40

45

50

Baseline 1 2 4 8 12 12 (MI)

Weeks

Vehicle
Trifarotene  50 µg/g

0.7% 4.5%
0.5%

8.2%

14.4%

25.7% 25.0%

3.2%

11.2%

23.3%*

35.8%* 35.7%†

Study 1 Face Study 2 Face

IG
A 

Su
cce

ss
 %

Weeks

0

5

10

15

20

25

30

35

40

45

50

Baseline

*P<.05; 95% CI (5.8, 14.1) ; † Treatment difference at Week 12 (95% CI) 16.6% (11.3, 22.0); P<.001

1 2 4 8 12 12 (MI)

Vehicle
Trifarotene  50 µg/g

0.7%
1.8% 3.9%

10.6%

25.8%

25.7%

0.5%

3.1%
5.6%

20.7%*

42.8%*
42.3%†

PG
A 

Su
cce

ss
 %

Weeks

*P<.05; 95% CI (5.8, 14.1) ; † Treatment difference at Week 12 (95% CI) 16.6% (11.3, 22.0); P<.001

0

5

10

15

20

25

30

35

40

45

50

Baseline 1 2 4 8 12 12 (MI)

Vehicle

Trifarotene  50 µg/g

0.7%
3.0%

5.7%

14.4%

30.1% 29.9%

1.3%

4.1%
8.6%

22.4%*

43.1%*
42.6%†

Study 1 trunk Study 2 trunk

Figure 3. Study 1 and Study 2 Safety Data (score is a 3-point scale) 
Study 1 Face

Study 2 trunk

Study 2 Face

Study 1 trunk
Week

1 2 4 8 12

Mild

M
ea

n 
Sc

or
e

1.25

1.50

1.00

0.75

0.50

0.25

0.00

Dryness Trifarotene 50 µg/g (N = 612)
Vehicle (N = 596)

Erythema
Stinging/Burning Scaling

Baseline
Final Visit

Worst

Week

M
ea

n 
Sc

or
e

1 2 4 8 12

1.25

1.50

1.00

0.75

0.50

0.25

0.00

Dryness Trifarotene 50 µg/g (N = 612)
Vehicle (N = 596)

Erythema
Stinging/Burning Scaling

Mild

Baseline
Final Visit

Worst

M
ea

n 
Sc

or
e

1 2 4 8

Week

12

1.25

1.50

1.00

0.75

0.50

0.25

0.00

Dryness Trifarotene 50 µg/g (N = 612)

Vehicle (N = 596)

Erythema

Stinging/Burning Scaling

Mild

Baseline
Final Visit

Worst

Mild

M
ea

n 
Sc

or
e

Week

1 2 4 8 12

Mild

1.25

1.50

1.00

0.75

0.50

0.25

0.00

Dryness Trifarotene 50 µg/g (N = 612)

Vehicle (N = 596)

Erythema

Stinging/Burning Scaling

Baseline
Final Visit

Worst

M
ea

n 
Sc

or
e

1.50

1.25

1.00

0.75

0.50

0.25

0.00

DrynessErythema

Mild

Stinging/BurningScaling

Weeks

Final Visit
Worst

Baseline

1 2 4 8 12 20 26 38 52

M
ea

n 
Sc

or
e

1.50

1.25

1.00

0.75

0.50

0.25

0.00

DrynessErythema

Mild
Stinging/BurningScaling

Weeks

Final Visit
Worst

Baseline

1 2 4 8 12 20 26 38 52

Severity scale score: 0 (none), 1 (mild), 2 (moderate), 3 (severe)

Face

trunk

Subject screened
N = 507

Subject enrolled
N = 455

Screen failure
N = 52

Discontinued
N = 2

Discontinued
N = 77

Subject treated
N = 453

Completed 6 months
of study protocol

N = 376

Discontinued
N = 28

Completed 12 months
of study protocol

N = 348

70

60

50

40

30

20

10

0

12 20 26 38 52

26.6

43.3
50.1

57.6

65.1

38.6

54.1
58.4

62.5
66.9

Baseline

Su
cce

ss
 R

at
e 

(%
)

Weeks

PGA (trunk)

IGA (face)

Figure 5. IGA/PGA success rates from Baseline to Week 52

Figure 4. Long-term Safety and Efficacy Study flowchart

Figure 1. Study 1 and Study 2 Flowchart

Figure 6. Local tolerability of trifarotene 50 µg/g cream