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A CLEAR CHOICE for Acne & Acne Scarring 

Acne scarring can have a lasting impact on patients that may be as significant as the impact of acne itself.¹ Because scars can be permanent, early and effective treatment of acne remains the best strategy to help reduce the risk of acne scarring.²a

AKLIEF® (triferotene) Cream, 0.005% demonstrated reduction in acne and atrophic acne scar counts in a Phase 4 study

The Phase 4 START study evaluated the impact of AKLIEF Cream on acne and atrophic acne scarring using a randomized split-face design. Patients with symmetrical acne lesions and scars received AKLIEF Cream on one side of the face and vehicle on the other, with video-recorded applications used to assess compliance. The primary endpoint was the change from baseline in total atrophic acne scar count per half-face at Week 243a 

Acne and acne scar reduction with AKLIEF Cream

AKLIEF Cream treats acne and helps to reduce existing acne scars and prevent future scarring in all phototypes3a

Week 1

Visible Improvement in acne lesions seen vs. vehicle group3,4bc

Week 2

7.9% reduction in total atrophic acne
scar counts from baseline3,4a

Week 12

33% reduction in total atrophic acne 
scar counts from baseline3,4a

Week 24

55.2% reduction in total atrophic
acne scar counts from baseline, with an overall scar reduction of greater than 50%3,4a

AKLIEF Cream significantly reduced acne scar counts as early as Week 2 

AKLIEF Cream demonstrated rapid and significant reductions in atrophic acne scar counts compared with vehicle. Treatment differences were observed as early as Week 2,  and continued through Week 24. Patients treated with AKLIEF Cream achieved a 51% reduction from baseline in total atrophic acne scar count versus 23% with vehicle3a

a. Absolute change in atrophic scar count from baseline through Week 24
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AKLIEF Cream was well tolerated in patients with acne scarring, with minimal treatment discontinuations

In the Phase 4 START study, AKLIEF Cream demonstrated favorable tolerability in patients with acne and atrophic acne scarring. Nearly all patients (99%) remained on treatment through Week 24, and fewer than 1% discontinued treatment due to treatment-emergent adverse events (TEAEs), supporting consistent use throughout the study period.3,4abc

n (%) due to TEAEsAKLIEF Creama (N=121)Vehicle Creama (N=121)       Overall       

Subjects with any TEAE

7 (5.8)3 (2.5)33 (27.3)

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

4 (3.3)3 (2.5)18 (14.9)

Subjects with any TEAE of special interest

1 (0.8)01 (0.8)

Subjects with any TEAE related to study drug

6 (5.0)2 (1.7)9 (7.4)

Subjects with any TEAE by greatest severityb

7 (5.8)3 (2.5)33 (27.3)

       Subjects with any TEAE whose greatest severity is mild

1 (0.8)3 (2.5)20 (16.5)

       Subjects with any TEAE whose greatest severity is moderate

4 (3.3)010 (8.3)

       Subjects with any TEAE whose greatest severity is severe

2 (1.7)03 (2.5)

Subjects with any TEAE leading to study discontinuation

1 (0.8)01 (0.8)

Subjects with any serious TEAE

000
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a. Secondary to clearing acne.

b. 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.

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

 

References

  1. Galderma Laboratories, L.P. Kantar burden survey, acne scars qualitative and quantitative report. March 2020.
  2. Layton A, et al. JAAD Int. 2021;5:41–48.
  3. Schleicher S, Moore A, Rafal E, et al. Trifarotene reduces risk for atrophic acne scars: results from a Phase 4 controlled study. Dermatol Ther (Heidelb). 2023;13(12):3085–3096.
  4. Galderma Laboratories, L.P. Data on file. Clinical Study Report (CSR) RD.06.SPR.202395. 2023.

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.