Ex vivo study vs Ultravate cream

The DUOBRII Lotion advantage–
More efficient delivery with once-daily targeted penetration1

 

With targeted penetration and 80% less steroid exposure, DUOBRII Lotion delivered halobetasol to the epidermis more effectively than Ultravate cream

Advanced lotion technology

As measured by a percentage of the applied dose, DUOBRII Lotion penetrated ~3x more efficiently than Ultravate cream

Study Design

Patented delivery technology in a moisturizing lotion1

 
Transmission electron micrograph of DUOBRII Lotion. Magnified 1,000 times.
Micron-sized emulsion droplets designed for optimal delivery1

Halobetasol and tazarotene are dissolved in same phase of emulsion in order to reach affected areas simultaneously. This allows for the agents in DUOBRII Lotion to begin working together immediately.1

DUOBRII Lotion improved barrier function and water retention1

 

Tewameter

Decreased trans-epidermal water loss (TEWL) over 24 hours, as compared to an untreated control site1

Corneometer

Increased moisture retention for up to 24 hours as measured by corneometry1

Nongreasy lotion, easily absorbed into skin1

Study Design

Layering with another agent may reduce tazarotene penetration and treatment adherence

 
In an ex vivo study, layering tazarotene with another active agent reduced tazarotene penetration into the epidermis and dermis1

At hour 24, the percent of applied dose of tazarotene was 400% more when tazarotene was applied alone vs when layered with Ultravate cream

Between hours 18 and 24, the percent of applied dose of tazarotene continued to increase with monotherapy while the layered combination of halobetasol cream and tazarotene remained stagnant

In a clinical study, psoriasis patients were more adherent with a once-daily administration of psoriasis medication (82%) than they were with twice-daily administration (44%)(P<0.001)2
Study Design
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Indication

DUOBRII™ (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, is indicated for the topical treatment of plaque psoriasis in adults.

Important Safety Information

Contraindication

DUOBRII Lotion is contraindicated in pregnancy.

Warnings and Precautions
  • Women of child-bearing potential should be warned of the potential risk of fetal harm from DUOBRII and use adequate birth-control. A negative result for pregnancy should be obtained within 2 weeks prior to treatment. If the patient becomes pregnant during treatment, discontinue DUOBRII Lotion and advise patient of the potential hazard to the fetus.
  • DUOBRII Lotion has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis during or after treatment and may require that patients be evaluated periodically during treatment.
  • Predisposing factors for HPA axis suppression include: use of more potent corticosteroids, use on large areas, use under occlusive dressings, use on altered skin barrier, concomitant use of other steroids, liver failure and young age.
  • Systemic effects of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria.
  • Local adverse reactions may include atrophy, striae, telangiectasias, folliculitis and contact dermatitis. If these effects occur, discontinue until the integrity of the skin has been restored. Do not resume treatment if contact dermatitis is identified. DUOBRII Lotion should not be used on eczematous skin, as it may cause severe irritation.
  • Avoid exposure to sunlight, sunlamps and weather extremes. Patients with sunburn should be advised not to use DUOBRII Lotion until fully recovered. DUOBRII Lotion should be administered with caution if the patient is also taking drugs known to be photosensitizers because of the increased potential for photosensitivity.
  • Topical corticosteroids may increase the risk of cataracts and glaucoma; advise patients to report any visual symptoms and refer to an ophthalmologist if needed.
Adverse Events
  • The most common adverse events in clinical trials were contact dermatitis (7%), application site pain (3%), folliculitis (2%), skin atrophy (2%), and excoriation (2%).

To report SUSPECTED ADVERSE REACTIONS, contact Ortho Dermatologics at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Please click here for full Prescribing Information.

References: 1. Data on file. 2. Zaghloul SS, Goodfield MJ. Objective assessment of compliance with psoriasis treatment. Arch Dermatol. 2004;140(4):408-414.

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INDICATION

IMPORTANT SAFETY INFORMATION

See More

DUOBRII™ (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, is indicated for the topical treatment of plaque psoriasis in adults.

IMPORTANT SAFETY INFORMATION

Contraindication

DUOBRII Lotion is contraindicated in pregnancy.

DUOBRII Lotion is contraindicated in pregnancy.