1 month

Extended remission:

2 phase 3 trials (P<0.001 in both trials):

  • 36% of patients in trial 1 and 45% in trial 2 achieved treatment success* at 8 weeks vs 7% and 13% with vehicle, respectively1
  • 4 weeks post treatment, 33% of patients in trial 1 and 33% of patients in trial 2 achieved treatment success* vs 9% and 9% with vehicle, respectively3

See study design

synergy

Greater clearance than with halobetasol alone:

Phase 2 trial:

  • 42.8% treatment success* with DUOBRII Lotion vs 8.9% with tazarotene and 23.6% with halobetasol (32.6% monotherapies combined)4

See study design

2%

Reduced epidermal atrophy:

2 phase 3 trials:

  • Only 2% of patients experienced
    epidermal atrophy1
  • The most common adverse reactions
    were contact dermatitis, application site
    pain, folliculitis, skin atrophy, and
    excoriation1
Once daily

No dosing limitation:

  • The only potent-to-superpotent steroid that has no time limits on dosing; use only until control is achieved1,5-9
  • DUOBRII Lotion was studied in two 8-week clinical trials and a 1-year safety study. Discontinue treatment if atrophy, striae, telangiectasias, or folliculitis occurs1,10

Your patients won't find these benefits in a single-agent topical steroid: they may need halobetasol plus tazarotene in once-daily DUOBRII Lotion1,2

Help your patients get the most out of their treatment with this guide to using DUOBRII Lotion

Download guide

Treatment success was defined as at least a 2-grade improvement from baseline in Investigator's Global Assessment score, and a score of "clear"
or "almost clear" (primary endpoint at Week 8).1,5

Study design (phase 3 trials): The safety and efficacy of DUOBRII Lotion were assessed in 2 prospective, multicenter, randomized, double-blind, phase 3 clinical trials in 418 adult patients with moderate-to-severe plaque psoriasis. Patients were treated with DUOBRII Lotion or vehicle, applied once daily and evaluated at 2, 4, 6, 8 weeks (primary endpoint), and post treatment at 12 weeks.1

Study design (phase 2 trial): A multicenter, double-blind, randomized, parallel-group phase 2 study to assess the safety, tolerability, and efficacy of DUOBRII Lotion in 212 patients with a clinical diagnosis of moderate-to-severe psoriasis. Patients were treated with DUOBRII Lotion, halobetasol 0.01%, tazarotene 0.045%, or vehicle, and evaluated at 2, 4, 6, 8 weeks (primary endpoint), and post treatment at 12 weeks. However, there was no prespecified statistical procedure controlling for Type 1 error rate (false positive rate).11

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. DUOBRII Lotion [prescribing information]. Bridgewater, NJ: Bausch Health US, LLC. 2. Elmets CA, Korman NJ, Prater EF, et al. Joint AAD-NPF Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol. Published online July 30, 2020. DOI: 10.1016/j.jaad.2020.07.087. 3. Gold LS, Lebwohl MG, Sugarman JL, et al. Safety and efficacy of a fixed combination of halobetasol and tazarotene in the treatment of moderate-to-severe plaque psoriasis: results of 2 phase 3 randomized controlled trials. J Am Acad Dermatol. 2018;79(2):287-293. 4. Kircik LH, Papp KA, Gold LS, et al. Assessing the synergistic effect of a fixed combination halobetasol propionate 0.01% and tazarotene 0.045% lotion in moderate-to-severe plaque psoriasis. J Drugs Dermatol. 2019;18(3):279-284. 5. Clobetasol propionate cream [prescribing information]. Lincolnton, NC: Cosette Pharmaceuticals, Inc. 6. Diprolene lotion [prescribing information]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp. 7. Enstilar foam [prescribing information]. Madison, NJ: LEO Pharma Inc. 8. Halobetasol propionate cream [prescribing information]. South Plainfield, NJ: G&W Laboratories, Inc. 9. Mometasone furoate cream [prescribing information]. South Plainfield, NJ: G&W Laboratories, Inc. 10. Data on file. 11. Sugarman JL, Gold LS, Lebwohl MG, et al. A phase 2, multicenter, double-blind, randomized, vehicle controlled clinical study to assess the safety and efficacy of a halobetasol/tazarotene fixed combination in the treatment of plaque psoriasis. J Drugs Dermatol. 2017;16(3):611-618.