Efficacy and safety of topical oxymetazoline cream 1.0% for treatment of persistent facial erythema associated with rosacea: findings from the 2 phase 3, 29-day, randomized, controlled REVEAL trials

Linda Stein-Gold, Leon H. Kircik, Zoe Diane Draelos, Philip Werschler, Janet DuBois, Edward Lain, Leslie Baumann, David J. Goldberg, Joely Kaufman, Emil A. Tanghetti, Nancy Alvandi, Emily Weng, David R. Berk, Gurpreet Ahluwalia

Research output: Contribution to journalArticle

Abstract

Background: Rosacea is a chronic dermatologic condition with limited treatment options. Objective: To evaluate topical oxymetazoline cream 1.0% in patients with moderate-to-severe persistent erythema of rosacea. Methods: Data were pooled from 2 identically designed phase 3 trials. Patients were randomized to receive oxymetazoline or vehicle once daily for 29 days and were followed for 28 days after treatment. The primary efficacy outcome was the proportion of patients with a 2-grade or greater improvement from baseline on both the Clinician Erythema Assessment (CEA) and Subject Self-Assessment for rosacea facial redness (SSA) at 3, 6, 9, and 12 hours after the dose on day 29. Results: The pooled population included 885 patients (78.8% of whom were female); 85.8% and 91.2% had moderate erythema according to the CEA and SSA, respectively. The primary outcome was achieved by significantly more patients in the oxymetazoline group than in the vehicle group (P <.001). Individual CEA and SSA scores and reduction in facial erythema (digital image analysis) favored oxymetazoline over vehicle (P <.001). The incidence of treatment-emergent adverse events was low (with oxymetazoline, 16.4%; with vehicle, 11.8%). No clinically relevant worsening of erythema (based on the CEA and SSA) was observed during the 28-day post-treatment follow-up period (with oxymetazoline, 1.7%; with vehicle, 0.6%). Limitations: Short-term treatment period. Conclusion: Oxymetazoline effectively reduced moderate-to-severe persistent facial erythema of rosacea and was well tolerated.

Original languageEnglish (US)
JournalJournal of the American Academy of Dermatology
DOIs
StateAccepted/In press - Jan 1 2018
Externally publishedYes

Fingerprint

Oxymetazoline
Rosacea
Erythema
Randomized Controlled Trials
Safety
Therapeutics

Keywords

  • facial dermatoses
  • skin abnormalities
  • vascular skin diseases
  • vasoconstrictor agents
  • α-adrenergic receptors
  • β-adrenergic receptors

ASJC Scopus subject areas

  • Dermatology

Cite this

Efficacy and safety of topical oxymetazoline cream 1.0% for treatment of persistent facial erythema associated with rosacea : findings from the 2 phase 3, 29-day, randomized, controlled REVEAL trials. / Stein-Gold, Linda; Kircik, Leon H.; Draelos, Zoe Diane; Werschler, Philip; DuBois, Janet; Lain, Edward; Baumann, Leslie; Goldberg, David J.; Kaufman, Joely; Tanghetti, Emil A.; Alvandi, Nancy; Weng, Emily; Berk, David R.; Ahluwalia, Gurpreet.

In: Journal of the American Academy of Dermatology, 01.01.2018.

Research output: Contribution to journalArticle

Stein-Gold, Linda ; Kircik, Leon H. ; Draelos, Zoe Diane ; Werschler, Philip ; DuBois, Janet ; Lain, Edward ; Baumann, Leslie ; Goldberg, David J. ; Kaufman, Joely ; Tanghetti, Emil A. ; Alvandi, Nancy ; Weng, Emily ; Berk, David R. ; Ahluwalia, Gurpreet. / Efficacy and safety of topical oxymetazoline cream 1.0% for treatment of persistent facial erythema associated with rosacea : findings from the 2 phase 3, 29-day, randomized, controlled REVEAL trials. In: Journal of the American Academy of Dermatology. 2018.
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abstract = "Background: Rosacea is a chronic dermatologic condition with limited treatment options. Objective: To evaluate topical oxymetazoline cream 1.0{\%} in patients with moderate-to-severe persistent erythema of rosacea. Methods: Data were pooled from 2 identically designed phase 3 trials. Patients were randomized to receive oxymetazoline or vehicle once daily for 29 days and were followed for 28 days after treatment. The primary efficacy outcome was the proportion of patients with a 2-grade or greater improvement from baseline on both the Clinician Erythema Assessment (CEA) and Subject Self-Assessment for rosacea facial redness (SSA) at 3, 6, 9, and 12 hours after the dose on day 29. Results: The pooled population included 885 patients (78.8{\%} of whom were female); 85.8{\%} and 91.2{\%} had moderate erythema according to the CEA and SSA, respectively. The primary outcome was achieved by significantly more patients in the oxymetazoline group than in the vehicle group (P <.001). Individual CEA and SSA scores and reduction in facial erythema (digital image analysis) favored oxymetazoline over vehicle (P <.001). The incidence of treatment-emergent adverse events was low (with oxymetazoline, 16.4{\%}; with vehicle, 11.8{\%}). No clinically relevant worsening of erythema (based on the CEA and SSA) was observed during the 28-day post-treatment follow-up period (with oxymetazoline, 1.7{\%}; with vehicle, 0.6{\%}). Limitations: Short-term treatment period. Conclusion: Oxymetazoline effectively reduced moderate-to-severe persistent facial erythema of rosacea and was well tolerated.",
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T1 - Efficacy and safety of topical oxymetazoline cream 1.0% for treatment of persistent facial erythema associated with rosacea

T2 - findings from the 2 phase 3, 29-day, randomized, controlled REVEAL trials

AU - Stein-Gold, Linda

AU - Kircik, Leon H.

AU - Draelos, Zoe Diane

AU - Werschler, Philip

AU - DuBois, Janet

AU - Lain, Edward

AU - Baumann, Leslie

AU - Goldberg, David J.

AU - Kaufman, Joely

AU - Tanghetti, Emil A.

AU - Alvandi, Nancy

AU - Weng, Emily

AU - Berk, David R.

AU - Ahluwalia, Gurpreet

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Background: Rosacea is a chronic dermatologic condition with limited treatment options. Objective: To evaluate topical oxymetazoline cream 1.0% in patients with moderate-to-severe persistent erythema of rosacea. Methods: Data were pooled from 2 identically designed phase 3 trials. Patients were randomized to receive oxymetazoline or vehicle once daily for 29 days and were followed for 28 days after treatment. The primary efficacy outcome was the proportion of patients with a 2-grade or greater improvement from baseline on both the Clinician Erythema Assessment (CEA) and Subject Self-Assessment for rosacea facial redness (SSA) at 3, 6, 9, and 12 hours after the dose on day 29. Results: The pooled population included 885 patients (78.8% of whom were female); 85.8% and 91.2% had moderate erythema according to the CEA and SSA, respectively. The primary outcome was achieved by significantly more patients in the oxymetazoline group than in the vehicle group (P <.001). Individual CEA and SSA scores and reduction in facial erythema (digital image analysis) favored oxymetazoline over vehicle (P <.001). The incidence of treatment-emergent adverse events was low (with oxymetazoline, 16.4%; with vehicle, 11.8%). No clinically relevant worsening of erythema (based on the CEA and SSA) was observed during the 28-day post-treatment follow-up period (with oxymetazoline, 1.7%; with vehicle, 0.6%). Limitations: Short-term treatment period. Conclusion: Oxymetazoline effectively reduced moderate-to-severe persistent facial erythema of rosacea and was well tolerated.

AB - Background: Rosacea is a chronic dermatologic condition with limited treatment options. Objective: To evaluate topical oxymetazoline cream 1.0% in patients with moderate-to-severe persistent erythema of rosacea. Methods: Data were pooled from 2 identically designed phase 3 trials. Patients were randomized to receive oxymetazoline or vehicle once daily for 29 days and were followed for 28 days after treatment. The primary efficacy outcome was the proportion of patients with a 2-grade or greater improvement from baseline on both the Clinician Erythema Assessment (CEA) and Subject Self-Assessment for rosacea facial redness (SSA) at 3, 6, 9, and 12 hours after the dose on day 29. Results: The pooled population included 885 patients (78.8% of whom were female); 85.8% and 91.2% had moderate erythema according to the CEA and SSA, respectively. The primary outcome was achieved by significantly more patients in the oxymetazoline group than in the vehicle group (P <.001). Individual CEA and SSA scores and reduction in facial erythema (digital image analysis) favored oxymetazoline over vehicle (P <.001). The incidence of treatment-emergent adverse events was low (with oxymetazoline, 16.4%; with vehicle, 11.8%). No clinically relevant worsening of erythema (based on the CEA and SSA) was observed during the 28-day post-treatment follow-up period (with oxymetazoline, 1.7%; with vehicle, 0.6%). Limitations: Short-term treatment period. Conclusion: Oxymetazoline effectively reduced moderate-to-severe persistent facial erythema of rosacea and was well tolerated.

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KW - skin abnormalities

KW - vascular skin diseases

KW - vasoconstrictor agents

KW - α-adrenergic receptors

KW - β-adrenergic receptors

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