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.

Abstract

BACKGROUND:

Side effects may limit the use of current tetracycline-class antibiotics for acne.

OBJECTIVE:

Evaluate the efficacy and safety of once-daily sarecycline, a novel, narrow-spectrum tetracycline-class antibiotic, in moderate to severe acne.

METHODS:

Patients 9-45 years with moderate to severe facial acne (Investigator's Global Assessment [IGA] score ≥ 3, 20-50 inflammatory and ≤ 100 noninflammatory lesions, and ≤ 2 nodules) were randomized 1:1 to sarecycline 1.5 mg/kg/day or placebo for 12 weeks in identically designed phase 3 studies (SC1401 and SC1402).

RESULTS:

In SC1401 (sarecycline n=483, placebo n=485) and SC1402 (sarecycline n=519, placebo n=515), at week 12, IGA success (≥ 2-grade improvement and score 0 [clear] or 1 [almost clear]) rates were 21.9% and 22.6% (sarecycline), respectively, versus 10.5% and 15.3% (placebo; P less than 0.0001 and P equals 0.0038). Onset of efficacy in inflammatory lesions occurred by the first visit (week 3), with mean percentage reduction in inflammatory lesions at week 12 in SC1401 and SC1402 of -51.8% and -49.9% (sarecycline), respectively, versus -35.1% and -35.4% (placebo; P less than 0.0001). Onset of efficacy for absolute reduction of noninflammatory lesion count occurred at week 6 in SC1401 (P less than 0.05) and week 9 in SC1402 (P less than 0.01). In SC1401, the most common TEAEs (in ≥ 2% of either sarecycline or placebo group) were nausea (4.6% [sarecycline]; 2.5% [placebo]), nasopharyngitis (3.1%; 1.7%), headache (2.7%; 2.7%), and vomiting (2.1%; 1.4%) and, in SC1402, nasopharyngitis (2.5%; 2.9%) and headache (2.9%; 4.9%). Most were not considered treatment-related. Vestibular (dizziness, tinnitus, vertigo) and phototoxic (sunburn, photosensitivity) TEAEs both occurred in ≤ 1% of sarecycline patients. Gastrointestinal TEAE rates for sarecycline were low. Among females, vulvovaginal candidiasis (SC1401: 1.1% [sarecycline] and 0 [placebo]; SC1402: 0.3% and 0) and mycotic infection (0.7% and 0; 1.0% and 0) rates were low.

CONCLUSION:

The narrow-spectrum antibiotic sarecycline was safe, well tolerated, and effective for moderate to severe acne, with low rates of side effects common with tetracycline antibiotics. J Drugs Dermatol. 2018;17(9):987-996.

• Authors: Angela Moore, Lawrence J Green, Suzanne Bruce, Neil Sadick, Eduardo Tschen, Philip Werschler, Fran E Cook-Bolden, Sunil S Dhawan, Douglass Forsha, Michael H Gold, Scott Guenthner, Steven E Kempers, Leon H Kircik, Jennifer L Parish, Marta I Rendon, Phoebe Rich, Linda Stein-Gold, Stephen K Tyring, Robert A Weiss, Adnan Nasir, Carsten Schmitz, Terry I Boodhoo, Alexandre Kaoukhov, David R Berk
• Journal: Journal of drugs in dermatology : JDD (J Drugs Dermatol) Vol. 17 Issue 9 Pg. 987-996 (Sep 01 2018) ISSN: 1545-9616 [Print] United States
• PMID: 30235387 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)

Chemical References

• Anti-Bacterial Agents
• Tetracyclines
• sarecycline

Topics

• Acne Vulgaris (drug therapy, pathology)
• Administration, Oral
• Adolescent
• Adult
• Anti-Bacterial Agents (administration & dosage, therapeutic use)
• Child
• Double-Blind Method
• Drug Administration Schedule
• Facial Dermatoses (drug therapy, pathology)
• Female
• Humans
• Male
• Middle Aged
• Randomized Controlled Trials as Topic
• Severity of Illness Index
• Tetracyclines (administration & dosage, therapeutic use)
• Treatment Outcome
• Young Adult