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A CLEAR CHOICE for Acne and Acne-Induced PIH

Acne-induced post-inflammatory hyperpigmentation (PIH) can be a persistent burden, with nearly one-third of patients reporting PIH as more bothersome than acne itself.¹ Early and effective acne treatment may help reduce the risk of PIH development.²

Phase 4 study evaluating acne and acne-induced PIH reduction

LEAP study was a Phase 4, multicenter, randomized, vehicle-controlled study evaluating AKLIEF (triferotene) Cream, 0.005% in patients with acne-induced PIH.³ab The primary endpoint, change from baseline in PIH Overall Disease Severity (ODS) score at Week 24 was not met.³ab However, faster PIH resolution versus vehicle was observed during the first 12 weeks of treatment, and improve through Week 243,4ab

Patients saw faster improvement of acne and acne-induced PIH when using AKLIEF Creamab

AKLIEF Cream rapidly decreased PIH severity in acne patients over the first 12 weeks of treatment and continued to reduce facial PIH through Week 24.3,4ab 

Week 12

Decreased PIH severity in patients with acne over the first 12 weeks of treatment.³ab

Week 24

Continued, progressively reduce facial PIH observed.3,4ab

With AKLIEF Cream, my dark spots have faded.6

– AKLIEF Cream patient

AKLIEF Cream rapidly decreased acne PIH severity over the first 12 weeksab

In the LEAP study, patients treated with AKLIEF Cream experienced greater reductions in post-inflammatory hyperpigmentation (PIH) severity during the first 12 weeks of treatment compared with vehicle. Although the study did not meet its primary endpoint at Week 24, these findings suggest AKLIEF Cream may contribute to earlier visible improvement in acne-associated PIH.3ab

AKLIEF Cream demonstrated greater continued reduction of facial post-acne hyperpigmentation index (PAHPI) through Week 24

AKLIEF Cream demonstrated greater reductions in PAHPI score from baseline through Week 24 versus vehicle, with greater separation observed at Weeks 20 and 24.3,4ab

See Real Patient Results

AKLIEF Cream demonstrated favorable safety with no study discontinuations due to TAEs

AKLIEF Cream was generally well tolerated throughout the LEAP study.³ab No study discontinuations due to TEAEs were reported in the AKLIEF Cream group, no serious TEAEs occurred, and most adverse events were mild to moderate in severity.³ Mean scores for erythema, dryness, scaling, and burning/stinging remained below mild during treatment.⁵ab 

 

    AKLIEF Cream 
n=60 
n (%) [events]    		Vehicle Cream
n=63
n (%) [events]

Subjects with any TEAE

10 (16.7) [11]19 (30.2) [26]

Subjects with any TEAE that occurred in ≥1% of subjects of the safety population

8 (13.3) [8]13 (20.6) [13]

Subjects with any TEAE of special Interest

000

Subjects with any TEAE due to COVID-19

3 (5.0) [3]6 (9.5) [6]

Subjects with any TEAE by closest relationship to study drug

  

       Subjects with any TEAE whose closest relationship to study drug is related

02 (3.2) [2]

Subjects with any TEAE whose closest relationship to study drug is not related

10 (16.7) [11]17 (27.0) [24]

Subjects with any TEAE by greatest severity

  

       Subjects with any TEAE whose greatest severity is mild

8 (13.3) [9]14 (22.2) [20]

       Subjects with any TEAE whose greatest severity is moderate

2 (3.3) [2]4 (6.3) [5]

       Subjects with any TEAE whose greatest severity is severe

01 (1.6) [1]

Subjects with any TEAE leading to study drug discontinuation

02 (3.2) [2]

Subjects with any TEAE leading to study discontinuation

00

Subjects with any serious TEAE

01 (1.6) [1]

COVID-19, coronavirus disease 2019; TEAE, treatment-emergent adverse event. Alexis A, et al. Int J Dermatol. 2024;63(6):806-815.

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*PIH, post-inflammatory hyperpigmentation

a. Secondary to clearing acne.

b. The primary endpoint was the overall disease severity score (ODS). No statistical significance between AKLIEF Cream and vehicle at Week 24 was seen.

References

  1. Abad-Casintahan F, et al. Postinflammatory hyperpigmentation in acne: a distressing sequela. J Dermatol. 2016;43:826–828.
  2. Layton A, et al. Early and effective acne management to reduce long-term sequelae. JAAD Int. 2021;5:41–48.
  3. Alexis A, et al. Efficacy and safety of trifarotene 50 μg/g cream in acne-induced post-inflammatory hyperpigmentation (LEAP study). Int J Dermatol. 2024;63(6):806–815.
  4. Galderma. Data on file. Clinical Study RD.06.SRE.204245. 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.