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A CLEAR CHOICE for Acne on the Face and Trunk

Rapid acne reduction

AKLIEF® (triferotene) Cream, 0.005% delivers rapid, robust lesion reduction with visible results in as little as 2 weeks on the face and trunk.2ab

See Results on the Face See Results on the Trunk

Pivotal Phase 3 study design for facial and truncal acne

AKLIEF Cream was evaluated in two pivotal, multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies conducted over 12 weeks. A total of 2,420 patients aged 9 years and older with moderate facial and truncal acne were randomized 1:1 to receive AKLIEF Cream or vehicle cream once daily. Safety evaluations included the assessment of adverse events and local cutaneous tolerability.²cd

Demonstrated results in facial acne

Rapid facial acne clearance with AKLIEF Cream

AKLIEF Cream delivered rapid, clinically meaningful facial acne clearance, significantly reducing both inflammatory and noninflammatory lesions.2ab

Week 2

Significant reduction in inflammatory and noninflammatory lesions seen by Week 2.2ab

Week 8

Delivered >50% reduction in facial inflammatory lesions by Week 8.2ab

Week 12

Up to 66.2% reduction in facial inflammatory lesions vs. baseline by Week 12.2ab

Since using AKLIEF Cream, I’m free to enjoy life again—no more worrying about my skin.6

-An actual patient

Significant reductions in facial inflammatory lesions observed as early as Week 1

In both pivotal studies 1 and 2, AKLIEF Cream demonstrated a significant mean percent reduction in facial inflammatory lesions versus vehicle by Week 1. Patients treated with AKLIEF Cream as a monotherapy, achieved more than 50% mean reduction in facial inflammatory lesions by Week 8, with continued improvement through Week 12.2

Facial Inflammatory Iesion Mean percent reduction with Aklief Cream

Mean percent reduction from baseline in facial inflammatory lesion count with AKLIEF Cream in pivotal Studies 1 and 2.

AKLIEF Cream significantly reduced facial non-inflammatory lesion (NIL) counts

In pivotal Studies 1 and 2, patients treated with AKLIEF Cream as a monotherapy achieved a significant mean percent reduction in facial non-inflammatory lesion counts compared with vehicle as early as Week 1, with further reductions observed through Week 12.2ab

Facial non-inflammatory lesion mean percept reduction with AKLIEF Cream

Mean percent reduction from baseline in facial non-inflammatory lesion count with AKLIEF Cream in pivotal Studies 1 and 2.

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Demonstrated results in truncal acne

AKLIEF Cream is effective for acne on chest, shoulders and back2ab

Week 2

Achieved significant reductions in both inflammatory and non-inflammatory lesions.2ab

Week 12

Delivered up to 65.4% truncal inflammatory lesions vs. Baseline.2ab

Significant reductions in truncal acne observed as early as Week 1 with AKLIEF Cream

AKLIEF Cream demonstrated clinically meaningful efficacy in truncal acne as monotherapy, with significant reductions in truncal inflammatory lesion counts versus vehicle observed as early as Week 1 in Study 2 and Week 2 in Study 1. Improvements continued through Week 12 in both pivotal studies.2,3,4,ab 

Mean percent reduction in truncal IL with AKLIEF Cream

Mean percent change from baseline in truncal inflammatory lesion count through Week 12 in pivotal Studies 1 and 2.

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AKLIEF Cream was well tolerated on the face and trunk

AKLIEF Cream demonstrated favorable tolerability across pivotal studies, with discontinuations due to adverse events occurring in fewer than 2% of patients. The most common adverse reactions were application-site irritation, application-site pruritus, and sunburn.2ab

n (%)AKLIEF Cream (n=1,220)Vehicle Cream (n=1,200)
Application site irritation91 (7.5)4 (0.3)
Application site pruritus29 (2.4)10 (0.8)
Sunburn32 (2.6)6 (0.5)
Support Patients Starting AKLIEF Cream
View Acne and Acne Scarring Clinical Data

a. Studied in acne patients from 9 to 58 years of age with diverse skin types and moderate-to-severe acne. Nodulocystic acne was excluded from the trials.

b. Significant improvement seen as early as Week 1 in the pivotal clinical trials.

c. Primary Endpoints: Significant reduction in facial inflammatory lesions (IL) and noninflammatory lesions (NIL)by Week 1 and superior Investigator Global Assessment (IGA) success (of clear/almost clear with >/= 2 grade) improvement vs. vehicle.2

d. Truncal acne improvement by Physician Global Assessment (PGA) success and absolute change in truncal IL’s and NILs from baseline to Week 12 and 50% mean percent reduction in truncal ILs by week 8 with significance by Week 22

References

  1. AKLIEF Press Release. Federal Drug Administration approval 2019. 

  2. 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.

  3. Galderma. Clinical Study Report RD.06.SRE.18251. Dallas, TX: Galderma Laboratories, L.P.

  4. Galderma. Clinical Study Report RD.06.SRE.18252. Dallas, TX: Galderma Laboratories, L.P.

  5. AKLIEF (trifarotene) cream, 0.005% [Prescribing Information]. Dallas, TX: Galderma Laboratories, L.P.

  6. Dias-Barbosa C, Taylor N, Chan K, York JP, Puelles J, Chavda R. Patient Insights on Acne Hyperpigmentation, Trifarotene, and Skincare: 6-Month, LEAP Phase 4 Qualitative Exit Interview Findings. Patient. 2026;19(2):343-352.

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.