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Once-Daily Oral Sarecycline 1.5 mg/kg/day is Effective for Moderate to Severe Acne Vulgaris
Results from Two 12-Week, Phase 3, Randomized, Double-blind Clinical Trials

Angela Moore, MD; Lawrence Green, MD2, Suzanne Bruce, MD; Neil Sadick, MD; Eduardo Tschen, MD, MBA; Philip Werschler, MD, FAAD, FAACS; Sunil Dhawan, MD; Douglas Forsha, MD; Michael Gold, MD, FAAD; Scott Guenthner, MD; Steve Kempers, MD; Leon Kircik, MD; 
Jennifer Parish, MD; Marta Rendon, MD; Phoebe Rich, MD; Linda Stein-Gold, MD; Stephen Tyring, MD, PhD; Robert Weiss, MD, FAAD; Adnan Nasir, MD; Carsten Schmitz, MD, PhD; Terry Boodhoo, MS; Alexandre Kaoukhov, MD; David Berk, MD; Fran Cook-Bolden, MD; Ayman Grada, MD, MS

Email: ayman.grada@Almirall.com

Introduction
 Oral broad-spectrum tetracycline-class antibiotics are prescribed for the  treatment of moderate to severe inflammatory acne
 Poor tolerability and bacterial resistance concerns may limit the use of broad-spectrum tetracycline antibiotics for the treatment of acne

Conclusions

Sarecycline, a narrow-spectrum tetracycline class antibiotic, FDA-approved for the treatment of moderate to severe acne in ages 9 and older, was safe, well tolerated, and statistically significant at 12 
weeks in achieving IGA Success (defined as ≥2-grade improvement and score 0 [clear] or 1 [almost clear]) and reduction in inflammatory lesion count.

Design & Methodology 
Male and female

Aged 9 to 45 years
Between 33 kg and 136 kg

Results 

Financial Support: This study was funded and sponsored by Allergan.  Sarecycline is owned and marketed by Almirall, LLC. USSEY0277               

SC1401 SC1402

Outcome Measure Sarecyclinen =- 483
Placebo
n = 485 P

Sarecycline
n = 519

Placebo
n = 515 P

IGA Success* 21.9% 10.5% 0.0001 22.6% 15.3% 0.0038

Mean Percent Reduction in 
Inflammatory Lesions 52.2% 35.2% 0.0001 50.8% 36.4% 0.0001

*Note:  IGA Success defined as ≥2-grade improvement and score 0 [clear] or 1 [almost clear] 

Table 1.  IGA Success and Inflammatory Lesion Efficacy at Week 12 
 To evaluate the efficacy and safety of sarecycline, a once-daily, narrow-spectrum tetracycline-class drug in moderate to 

severe acne

Objective

Moderate to severe (IGA ≥ 3) facial acne 
20 – 50 Inflammatory Lesions

≤ 100 Noninflammatory Lesions
≤ 2 Nodules

 Two phase 3 multicentre, randomized, double-blind, placebo-controlled, parallel group studies. 
 Up to 35 day screening period to establish eligibility and  baseline
 12 week double-blind treatment with study visits at 3, 6, 9, and 12 weeks 

Subjects randomized 1:1 to 
Sarecycline 1.5 mg/kg/day oral or Placebo

In SC1401 and SC1402 (Table 1) IGA success rates were 21.9% and 22.6% (sarecycline) versus 10.5% and 15.3% (placebo; P < .0001 
and P = .0038). Onset of efficacy in inflammatory lesion reduction occurred as early as week 3, with mean percentage reduction in 
inflammatory lesions at week 12 in SC1401 and SC1402 of 52.5% and 50.8% (sarecycline) versus 35.2% and 36.4% (placebo) (Figs 1 & 
2).  Efficacy on truncal acne in (Fig 3). Adverse events ≥ 2% in any group are shown in Table 2.

 Co-primary efficacy endpoints:  
 Absolute change in facial inflammatory lesion count at week 12
 IGA Success – IGA score of 0 (clear) or 1 (almost clear) and ≥ 2 point improvement from baseline

 Secondary endpoints included absolute and percent change from baseline in inflammatory lesions at weeks 3, 6, & 9.

Table 2.  Adverse Events ≥ 2% in any group 
SC1401 SC1402

TEAEs Sarecycline
n = 481

Placebo
n = 483

TEAEs Sarecycline
n = 513

Placebo
N = 513

Nausea
Nasopharyngitis

Headache
Vomiting

4.6%
3.1%
2.7%
2.1%

2.5%
2.9%
2.7%
1.4%

Nasopharyngitis
Headache

2.5%
2.9%

2.9%
4.9%

BASELINE WEEK 3 WEEK 12

Vestibular, phototoxic, vulvovaginal candidiasis, 
and mycotic infections ≤1.1% in sarecycline 
treated patients. Gastrointestinal TEAE rates 
were low

BASELINE WEEK 3 WEEK 12

Reference: Moore A, Green LJ, Bruce S, et al. Once-Daily Oral Sarecycline 1.5 mg/kg/day Is Effective for Moderate to Severe Acne Vulgaris: Results from Two Identically Designed, Phase 3, Randomized, Double-Blind Clinical Trials. Journal of drugs in dermatology: JDD. 2018 Sep;17(9):987-96.

Fig 1 & 2. Mean % Reduction in Inflammatory Lesions Fig 3. Truncal Acne: % of Patients with IGA success at WK 12 


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