Phase 3 clinical trials

Significant topical efficacy vs vehicle with once-daily dosing plus extended efficacy 4 weeks post treatments2,3

Patients with treatment success* (8 week primary endpoint)
Trial 1 8 weeks: 36% treatment success with DUOBRII Lotion vs 7% with vehicle. Trial 2 8 weeks: 45% treatment success with DUOBRII Lotion vs 13% with vehicle Trial 1 8 weeks: 36% treatment success with DUOBRII Lotion vs 7% with vehicle. Trial 2 8 weeks: 45% treatment success with DUOBRII Lotion vs 13% with vehicle
Trial 1 8 weeks: 36% treatment success with DUOBRII Lotion vs 7% with vehicle. Trial 2 8 weeks: 45% treatment success with DUOBRII Lotion vs 13% with vehicle Trial 1 8 weeks: 36% treatment success with DUOBRII Lotion vs 7% with vehicle. Trial 2 8 weeks: 45% treatment success with DUOBRII Lotion vs 13% with vehicle
Study design
Hal holding picture of a patient with plaque psoriasis
Superior clearance vs vehicle at 8 weeks in both trials (P<0.001)3

The topical combination lotion for plaque psoriasis with long-term efficacy

  • The most common adverse events in clinical trials were contact dermatitis (7%), application site pain (3%), folliculitis (2%), skin atrophy (2%), and excoriation (2%).
*Treatment success was defined as at least a 2-grade improvement from baseline in Investigator's Global Assessment (IGA) score and a score of “clear” or “almost clear” (primary endpoint at week 8).2
†The treatment difference at Week 2 in Trial 1 was not statistically significant.
 
Taz holding picture of a patient with plaque psoriasis

Additional studies

Results of an open-label, long-term (1-year) safety study4

Percent of patients with a baseline BSA of 3%-12% who achieved and also maintained treatment success‡
1 month post treatment: 55%

n=125/226

2 months post treatment: 28%

n=64/226

3 months post treatment: 19%

n=44/226

Hal and Taz walking side-by-side with Hal holding a daily calendar and pages blowing away behind him
Efficacy was evaluated using descriptive statistics
Adverse events seen in a long-term safety study through 8 weeks were consistent with those seen in the phase 3 studies
  • Rate of epidermal atrophy during the long-term study was 0.7%
  • The percentage of subjects with reported adverse events at 8 weeks did not increase throughout the rest of the study (52 weeks)
  • Some individuals may experience atrophy, striae, telangiectasias, and folliculitis. If these effects occur, discontinue until the integrity of the skin has been restored
  • Efficacy results from an open-label study should be interpreted with caution

‡Treatment success was defined as at least a 2-grade improvement from baseline in the IGA score, and a score of “clear” or “almost clear”. Retreatment occurred when IGA was at 2-mild. Patients achieved treatment success at any point during the study. 4

Study design

See the results of an open-label pilot study of 20 patients with psoriasis with scalp involvement1

In pivotal trials, the scalp was not treated with DUOBRII and not included in IGA/BSA assessment.

PRIMARY ENDPOINT

At week 8, 48% (n=10/21) of patients were clear or almost clear on overall IGA1

Psoriasis Scalp Severity Index (PSSI) scores

Overall treatment success (IGA: 33% treatment success with DUOBRII Lotion vs 34% with vehicle) 2-grade improvement in signs of psoriasis (Erythema: 34% treatment success with DUOBRII Lotion vs 43% with vehicle; Plaque elevation: 54% treatment success with DUOBRII Lotion vs 51% with vehicle; Scaling: 61% treatment success with DUOBRII Lotion vs 51% with vehicle) blobid0.gif blobid0.giff
PSSI 75 was a secondary endpoint and PSSI 90 and PSSI 100 were exploration endpoints.

SELECT SECONDARY ENDPOINT

72% (n=15/21) of patients were clear or almost clear at week 8 on the scalp IGA1

SELECT SECONDARY ENDPOINT

72% (n=15/21) of patients were clear or almost clear at week 8 on the scalp IGA1
BSA, body surface area; IGA, investigator's global assessment.

Study design1

A single-center open-label 12-week pilot study designed to assess treatment with fixed combination tazarotene 0.045% and halobetasol propionate 0.01% lotion in adult subjects (age 18 or older) with moderate-to-severe plaque psoriasis, as indicated by an Investigator's Global Assessment (IGA) scale value of 3 or 4, with scalp involvement. Efficacy was measured by the percentage of patients who were clear or almost clear on IGA at week 8 (primary endpoint). Secondary endpoints included percentage of patients who were clear or almost clear on IGA at weeks 4 and 12; percentage of patients who achieved Psoriasis Scalp Severity Index (PSSI) 75 and Scalp IGA 0/1, and BSA improvement at weeks 4, 8, and 12.

Safety Measures1

Seven adverse events occurred in 5 subjects. None were serious or appeared to be related to the use of DUOBRII. Additional safety evaluation included VAS for pruritus. Local tolerability assessment included itching, dryness, burning/stinging.

Study Limitations1

Results are from an open-label study that included exploratory endpoints and therefore should be interpreted with caution.

Study design1

A single-center open-label 12-week pilot study designed to assess treatment with fixed combination tazarotene 0.045% and halobetasol propionate 0.01% lotion in adult subjects (age 18 or older) with moderate-to-severe plaque psoriasis, as indicated by an Investigator's Global Assessment (IGA) scale value of 3 or 4, with scalp involvement. Efficacy was measured by the percentage of patients who were clear or almost clear on IGA at week 8 (primary endpoint). Secondary endpoints included percentage of patients who were clear or almost clear on IGA at weeks 4 and 12; percentage of patients who achieved Psoriasis Scalp Severity Index (PSSI) 75 and Scalp IGA 0/1, and BSA improvement at weeks 4, 8, and 12.

Safety Measures1

Seven adverse events occurred in 5 subjects. None were serious or appeared to be related to the use of DUOBRII. Additional safety evaluation included VAS for pruritus. Local tolerability assessment included itching, dryness, burning/stinging.

Study Limitations1

Results are from an open-label study that included exploratory endpoints and therefore should be interpreted with caution.

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Important Safety Information and Indication

Contraindication

DUOBRII Lotion is contraindicated in pregnancy.

Warnings and Precautions
  • Embryofetal risks. Women of child-bearing potential should be warned of the potential risk of fetal harm from DUOBRII and use adequate birth-control during treatment with DUOBRII. 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.
  • Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Unwanted Systemic Glucocorticoid Effects. 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. 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. Photosensitivity and Risk for Sunburn. 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 of augmented photosensitivity.
  • Ophthalmic Adverse Reactions. Topical corticosteroids may increase the risk of cataracts and glaucoma; advise patients to report any visual symptoms and refer to an ophthalmologist if needed.
  • Concomitant Skin Infections: An appropriate antimicrobial agent should be used if skin infection is present or develops. If favorable response does not promptly occur, discontinue use of DUOBRII until infection has been adequately treated.
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.

Indication

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

Please click here for full Prescribing Information.

References: 1. Ozyurekoglu E, Kircik LH. An open-label pilot study to investigate safety and efficacy of fixed combination tazarotene 0.045% and halobetasol propionate 0.01% lotion for the treatment of scalp psoriasis. J Drugs Dermatol. 2021;20(11):1191-1194. 2. DUOBRII Lotion [prescribing information]. Bridgewater, NJ: Bausch Health US, LLC. 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. Lebwohl MG, Stein Gold L, Papp K, et al. Long-term safety and efficacy of a fixed-combination halobetasol propionate 0.01%/tazarotene 0.045% lotion in moderate-to-severe plaque psoriasis: phase 3 open-label study. J Eur Acad Dermatol Venereol. 2021;35(5):1152-1160.

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Important Safety Information and Indication

Important Safety Information and Indication

See More
Contraindication

DUOBRII Lotion is contraindicated in pregnancy.

Warnings and Precautions
  • Embryofetal risks. Women of child-bearing potential should be warned of the potential risk of fetal harm from DUOBRII and use adequate birth-control during treatment with DUOBRII. 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.
Contraindication

DUOBRII Lotion is contraindicated in pregnancy.

Warnings and Precautions