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For persistent facial erythema associated with rosacea in adults REDUCE
THE REDNESS Help your patients take a step closer to a more normal, healthy skin color1,2

Illustration only.

Persistent erythema

Persistent facial erythema is the
most common sign of rosacea3

  • Approximately 16 million Americans are affected by rosacea4
    • Emergence of persistent facial erythema is a key to rosacea diagnosis3,5
  • Persistent erythema is bothersome for patients with rosacea6
  • May become progressively more persistent and can worsen over time7

RHOFADE® cream is the first and only α1A adrenoceptor agonist approved for the topical treatment of persistent facial erythema associated with rosacea in adults1

See RHOFADE® cream
in action

Lasting results

RHOFADE® cream significantly improved erythema with lasting results2

Subjects With 2-Grade Improvement From Baseline in Both CEA and SSA Scores Over 12 Hours on Day 291

Trial 1

Hour on Day 29 RHOFADE® Cream(n = 222; P < 0.05 vs vehicle) Vehicle(n = 218)
3 12% 6%
6 16% 8%
9 18% 6%
12 15% 6%

Trial 2

Hour on Day 29 RHOFADE® Cream(n = 224; P < 0.05 vs vehicle) Vehicle(n = 221)
3 14% 7%
6 13% 5%
9 16% 9%
12 12% 6%

CEA = Clinician Erythema Assessment. SSA = Subject Self-Assessment for rosacea facial redness.

Results of 2 identical 29-day, randomized, double-blind, parallel-group, vehicle-controlled studies to evaluate the safety and effectiveness of once-daily RHOFADE® cream in 885 subjects with moderate to severe persistent facial erythema associated with rosacea. The primary end point was the proportion of subjects with at least a 2-grade improvement in erythema from baseline (pre-dose on day 1) on both the CEA and SSA scales measured at hours 3, 6, 9, and 12 on day 29.1

To achieve composite success, physicians and subjects had to independently rate the change in erythema as a 2-grade or greater improvement on similar 5-point scales.1

4severe
3moderate
2mild
1almost clear
0clear/no signs of unwanted redness

Composite success was required to meet the primary end point1

Proportion of subjects with 2-grade
improvement in erythema1

CEA and SSA scales rate severity of erythema as follows: 4 = severe; 3 = moderate; 2 = mild; 1 = almost clear; 0 = clear/no signs of unwanted redness.2

Before and after

RHOFADE® cream significantly improved erythema with lasting results—a step closer to a more normal, healthy skin color1,2

BEFORE
Day 1: Pre-dose
AFTER
Day 29
Unretouched photos of clinical trial subject. Individual results may vary.

On day 29 a 2-grade reduction in erythema was achieved by 12% to 18% of subjects treated with RHOFADE® cream vs 5% to 9% with vehicle.1
BEFORE
Day 1: Pre-dose
AFTER
Day 29
Unretouched photos of clinical trial subject. Individual results may vary.

On day 29 a 2-grade reduction in erythema was achieved by 12% to 18% of subjects treated with RHOFADE® cream vs 5% to 9% with vehicle.1
BEFORE
Day 1: Pre-dose
AFTER
Day 29
Unretouched photos of clinical trial subject. Individual results may vary.

On day 29 a 2-grade reduction in erythema was achieved by 12% to 18% of subjects treated with RHOFADE® cream vs 5% to 9% with vehicle.1
BEFORE
Day 1: Pre-dose
AFTER
Day 29
Unretouched photos of clinical trial subject. Individual results may vary.

On day 29 a 2-grade reduction in erythema was achieved by 12% to 18% of subjects treated with RHOFADE® cream vs 5% to 9% with vehicle.1
Unretouched photos of clinical trial subject. Individual results may vary.

On day 29 a 2-grade reduction in erythema was achieved by 12% to 18% of subjects treated with RHOFADE® cream vs 5% to 9% with vehicle.1
Unretouched photos of clinical trial subject. Individual results may vary.

On day 29 a 2-grade reduction in erythema was achieved by 12% to 18% of subjects treated with RHOFADE® cream vs 5% to 9% with vehicle.1
Unretouched photos of clinical trial subject. Individual results may vary.

On day 29 a 2-grade reduction in erythema was achieved by 12% to 18% of subjects treated with RHOFADE® cream vs 5% to 9% with vehicle.1
Unretouched photos of clinical trial subject. Individual results may vary.

On day 29 a 2-grade reduction in erythema was achieved by 12% to 18% of subjects treated with RHOFADE® cream vs 5% to 9% with vehicle.1

Proven tolerability

In pivotal trials, few subjects discontinued due to adverse events
(2.2% with RHOFADE® cream vs 0.2% with vehicle)2

Three 4-week clinical trials included 972 subjects1

Adverse Reactions Reported by 1% of Subjects Through 4 Weeks of Treatment in Controlled Clinical Trials1

Adverse Reaction RHOFADE® Cream (N = 489) Vehicle Cream (N = 483)
Application-site dermatitis 9 (2%) 0
Worsening inflammatory lesions of rosacea 7 (1%) 1 (< 1%)
Application-site pruritus 5 (1%) 4 (1%)
Application-site erythema 5 (1%) 2 (< 1%)
Application-site pain 4 (1%) 1 (< 1%)
A total of 489 subjects with persistent facial erythema associated with rosacea were treated with RHOFADE® cream once daily for 4 weeks in 3 controlled clinical trials.1

The 52-week, open-label safety trial included 440 subjects1,2

Adverse Reactions Over a 52-Week Treatment Period1,2

Adverse Reaction RHOFADE® Cream (N = 440)
Worsening inflammatory lesions of rosacea 14 (3%)
Application-site dermatitis 13 (3%)
Application-site pruritus 9 (2%)
Application-site pain 9 (2%)
Application-site erythema 7 (2%)
An additional 440 subjects with persistent facial erythema associated with rosacea were also treated with RHOFADE® cream once daily for up to 1 year in a long-term, open-label clinical trial.1,2

Once-a-day,
everyday dosing1

Helpful instructions to discuss with your patients:

Apply 1 pea-sized amount once a day—every day—in a thin layer to cover the entire face (forehead, nose, each cheek, and chin), avoiding the eyes and lips1

Wash hands immediately after application1

Not for oral, ophthalmic, or intravaginal use1

Continue to avoid common triggers

Patient savings

Most commercially insured patients pay about $1/day or less for once-a-day—every day—RHOFADE® cream

Each 30-gram tube of RHOFADE® cream contains approximately a 70-day supply of medicine*

PATIENTS MAY PAY AS LITTLE AS$0PER PRESCRIPTION IF:

  • They have commercial insurance
  • RHOFADE® cream is covered by their plan
  • They have met their deductible

PATIENTS MAY PAY AS LITTLE AS$50PER PRESCRIPTION IF:

  • They have commercial insurance
  • RHOFADE® cream is not covered by their plan
  • They have not met their deductible

*Estimate based on the average daily use of RHOFADE® cream in clinical trials. In phase 3 clinical trials, mean daily usage was 0.43 grams per day.2 Therefore, a 30-gram tube used daily would last approximately 70 days.

Limitations apply. Uninsured and government-insured patients are not eligible for these offers.

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INDICATION

RHOFADE® (oxymetazoline HCl) cream 1% is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Potential Impacts on Cardiovascular Disease

Alpha-adrenergic agonists may impact blood pressure. RHOFADE® cream should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension/hypotension. Advise patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension/hypotension to seek immediate medical care if their condition worsens.

Potentiation of Vascular Insufficiency

RHOFADE® cream should be used with caution in patients with cerebral or coronary insufficiency, Raynaud’s phenomenon, thromboangiitis obliterans, scleroderma, or Sjögren’s syndrome. Advise patients to seek immediate medical care if signs and symptoms of potentiation of vascular insufficiency develop.

Risk of Angle Closure Glaucoma

RHOFADE® cream may increase the risk of angle closure glaucoma in patients with narrow-angle glaucoma. Advise patients to seek immediate medical care if signs and symptoms of acute angle closure glaucoma develop.

ADVERSE REACTIONS

The most common adverse reactions for RHOFADE® cream were: application-site dermatitis 2%, worsening inflammatory lesions of rosacea 1%, application-site pruritus 1%, application-site erythema 1%, and application-site pain 1%.

Please see full Prescribing Information for RHOFADE® cream.

References

  1. RHOFADE® cream Prescribing Information, 2017.
  2. Data on file, Allergan.
  3. Wilkin J, Dahl M, Detmar M, et al. Standard classification of rosacea: Report of the National Rosacea Society Expert Committee on the Classification and Staging of Rosacea. J Am Acad Dermatol. 2002;46(4):584-587.
  4. Rosacea now estimated to affect at least 16 million Americans. Rosacea Review. Winter 2010. National Rosacea Society website. www.rosacea.org/rr/2010/winter/article_1.php. Accessed April 26, 2017.
  5. Tan J, Almeida L, Bewley A, et al. Updating the diagnosis, classification and assessment of rosacea: recommendations from the global ROSacea COnsensus (ROSCO) panel [published online ahead of print October 8, 2016]. Br J Dermatol. doi: 10.1111/bjd.15122.
  6. Huynh TT. Burden of disease: the psychosocial impact of rosacea on a patient’s quality of life. Am Health Drug Benefits. 2013;6(6):348-354.
  7. Del Rosso JQ. Advances in understanding and managing rosacea: part 2. The central role, evaluation, and medical management of diffuse and persistent facial erythema of rosacea. J Clin Aesthet Dermatol. 2012;5(3):26-36.
  8. Del Rosso JQ. Advances in understanding and managing rosacea: part 1. Connecting the dots between pathophysiological mechanisms and common clinical features of rosacea with emphasis on vascular changes and facial erythema. J Clin Aesthet Dermatol. 2012;5(3):16-25.