Oral Sarecycline for Treatment of Papulopustular Rosacea: Results of a Pilot Study of Effectiveness and Safety

April 2021 | Volume 20 | Issue 4 | Original Article | 426 | Copyright © April 2021

Published online March 25, 2021

James Q. Del Rosso DO,a Zoe Diana Draelos MD,b Cheryl Effron MD,c Leon H. Kircik MDd

aJDR Dermatology Research/Thomas Dermatology, Las Vegas, NV
bDermatology Consulting Services, PLLC, High Point, NC
cCosmetic Dermatology of Orange County, Anaheim Hills, CA
dIcahn School of Medicine at Mount Sinai, NY; Indiana Medical Center, Indianapolis, IN; Physicians Skin Care, PLLC; DermResearch, PLLC, Louisville, KY

Lesion Count Primary Endpoint
Total inflammatory lesion counts (papules, pustules) were evenly distributed at baseline (P=0.13). Both sarecycline and Centrum produced absolute and percent reductions in lesion counts at weeks 4, week 8, and week 12 (EOS) relative to baseline (P<.001 for all). Absolute and percent lesion count reductions were greater in the sarecycline group at all study visits (P<.001 for all). Summary data for total inflammatory lesion counts observed throughout the study are shown in Table 3. These results demonstrate statistically superior total inflammatory lesion count reductions at week 12 (EOS) with sarecycline as compared to Centrum (P<.0001). Then secondary endpoint evaluations of total inflammatory lesion count reductions at week 4 and week 8 in both study groups are also shown in Table 3.

Subject Global Assessment
There was a significant favorable change in Subject Global Assessment (SGA) scores in the sarecycline group (P<.001), but no significant change in the Centrum group (P=.68) from week 4 to week 12 (EOS). At week 12, 44 percent, 35 percent, and 21 percent of subjects reported “much better”, “slightly better”, or “same” in the sarecycline group, respectively, as compared to 16 percent, 16 percent, and 56 percent in the Centrum group, respectively. No sarecycline-treated subjects reported worsening of rosacea at any time point during the study, as compared to 12 percent of Centrum-treated subjects at week 8 and week 12.

Local Signs and Symptoms (Facial Skin)
Erythema, dryness, peeling, oiliness, and pruritus were evenly distributed between treatment groups at baseline; burning sensation was also not significantly different between both groups (P=.07). Absent or trace ratings for erythema at week 12, were significantly better in the sarecycline group (63 percent of subjects) as compared to the Centrum group (12% of subjects; P<.0001). From baseline to week 12, significant reductions in dryness were observed in the sarecycline group (P=.01). Absent or trace ratings for dryness at week 12 were reported in 98 percent in the sarecycline group and 84 percent in the Centrum group (P=.02). Significant reductions in peeling from baseline to week 12 were observed in the sarecycline group (P=.02) and not in the Centrum group (P=.77), with absent or trace peeling noted in 98 percent of sarecycline-treated subjects. Oiliness was not commonly observed among subjects in either treatment group. Sarecycline-treated subjects exhibited statistically significantly greater reduction in sensation of skin burning (P=.01), with absent or trace ratings documented in 96 percent of subjects receiving sarecycline versus 76 percent of those receiving Centrum (P=.038). Absent or trace ratings of pruritus at week 12 were significantly greater in the sarecycline group 94 percent of subjects) than in the Centrum group (76 percent of subjects; P=.023), with significant reductions also observed only in the sarecycline group from baseline to week 12 (P<.001).

Adverse Events
There were 26 AEs that occurred in 16 subjects in the sarecycline group at some time point during the study. Nine were considered “definitely related”, 3 were “probably related”, and 3 were “possibly related” to study drug as determined by the investigator. Seven AEs were rated as mild, 17 as moderate, and 2 as severe based on AE severity grading, with none determined to be serious AEs. Among the AEs of specific interest in patients treated with a tetracycline derivative, nausea occurred in 2 subjects, headache in 2 subjects, and facial sunburn in 2 subjects (1 mild case determined to be unrelated to study drug). Dosing was interrupted in 2 subjects for AEs determined to not be related to study drug (tinea versicolor, “unknown rash”). Sarecycline was discontinued in 3 subjects, with 2 AEs probably related to sarecycline (headache, gastroenteritis) and 1 AE unlikely related to sarecycline (“boil on leg”). In all other cases, no specific interventions occurred; all AEs resolved in cases where follow-up with subjects was possible, with the two exceptions of one case of mild nausea that was ongoing and one case of headache that was ongoing at EOS, neither of which underwent therapeutic intervention.


Papulopustular rosacea is a common presentation of cutaneous rosacea which has been reported to be bothersome to affected patients. In this investigator-initiated, investigator-blinded, 12- week study, 97 subjects were enrolled. Seventy-two subjects received oral sarecycline once daily (daily dose based on patient weight) and 25 subjects received one Centrum oral multivitamin tablet daily. The results of the study demonstrate that oral sarecycline is efficacious for papulopustular rosacea in adults based on both IGA assessments and documentation of total inflammatory lesion reductions. Additionally, evaluation of local signs and symptoms of facial skin are typically included as part of the safety and tolerability evaluation. However, as this study assesses signs and symptoms at baseline and throughout the study, and is evaluating oral therapy only, the noted significant improvements in facial skin manifestations such erythema, dryness, peeling, burning, and pruritus are believed to be reflective of the therapeutic response of rosacea to oral sarecycline. The type, frequency, and severity of AEs reported in this study are consistent with what has been reported with oral sarecycline in the pivotal trials completed that support its US FDA approval for treatment of acne vulgaris. Additional studies are suggested to further evaluate the use of oral sarecycline for the treatment of rosacea.


Dr. Del Rosso is a research investigator, consultant, and speaker for Almirall, Bausch Health, Galderma, Leo Pharma, and Vyne Therapeutics, and a consultant and speaker for EPI Health and Mayne Pharma.