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J Am Acad Dermatol. 2018 Jun;78(6):1156-1163. doi: 10.1016/j.jaad.2018.01.027. Epub 2018 Jan 31.

Efficacy and safety of oxymetazoline cream 1.0% for treatment of persistent facial erythema associated with rosacea: Findings from the 52-week open label REVEAL trial.

Author information

1
Dermatology Consulting Services, High Point, North Carolina. Electronic address: zdraelos@northstate.net.
2
Tennessee Clinical Research Center, Nashville, Tennessee.
3
Laser Skin & Vein Institute, Hunt Valley, Maryland.
4
Baumann Cosmetic & Research Institute, Inc, Miami, Florida.
5
Grekin Skin Institute, Southfield, Michigan.
6
Connecticut Dermatology Group, Norwalk, Connecticut.
7
Associated Skin Care Specialists, Fridley, Minnesota.
8
Allergan plc, Irvine, California.

Abstract

BACKGROUND:

Limited treatments are available for persistent erythema of rosacea.

OBJECTIVE:

To examine the long-term safety and efficacy of oxymetazoline cream 1.0% in patients with rosacea with moderate-to-severe persistent erythema.

METHODS:

Patients applied oxymetazoline once daily for 52 weeks. Safety assessments included treatment-emergent adverse events (TEAEs), skin blanching, inflammatory lesion counts, telangiectasia, disease severity, and rebound effect. Efficacy was assessed by the Clinician Erythema Assessment and Subject Self-Assessment composite score at 3 and 6 hours after the dose on day 1 and at weeks 4, 26, and 52.

RESULTS:

Among 440 patients, 8.2% reported treatment-related TEAEs; the most common were application-site dermatitis, paresthesia, pain, and pruritus. The rate of discontinuation due to adverse events (mostly application-site TEAEs) was 3.2%. No clinically meaningful changes were observed in skin blanching, inflammatory lesions, or telangiectasia. At week 52, 36.7%, and 43.4% of patients achieved a 2-grade or greater composite improvement from baseline in both Clinician Erythema Assessment and Subject Self-Assessment 3 and 6 hours after a dose, respectively. Less than 1% of patients experienced a rebound effect following treatment cessation.

LIMITATIONS:

A vehicle-control group was not included.

CONCLUSION:

This long-term study demonstrated sustained safety, tolerability, and efficacy of oxymetazoline for moderate-to-severe persistent erythema of rosacea.

KEYWORDS:

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

PMID:
29409914
DOI:
10.1016/j.jaad.2018.01.027
[Indexed for MEDLINE]
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