• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • Patient Education
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Duobrii (halobetasol propionate and tazarotene)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Duobrii (halobetasol propionate and tazarotene)

  • Profile

Profile

Contact Information

Currently Enrolling Trials

    Show More

    General Information

    Duobrii is a combination of halobetasol propionate, a corticosteroid and tazarotene, a retinoid prodrug.

    Duobrii is specifically indicated for the topical treatment of plaque psoriasis in adults. 

    Duobrii is supplied as a lotion for topical administration. Each gram of Duobrii Lotion contains 0.1 mg (0.01%) halobetasol propionate and 0.45 mg (0.045%) tazarotene. Apply a thin layer of Duobrii Lotion once daily to cover only affected areas and rub in gently. If a bath or shower is taken prior to application, the skin should be dry before applying the lotion. The total dosage should not exceed approximately 50 g per week because of the potential for the drug to suppress the hypothalamicpituitary-adrenal (HPA) axis. Do not use with occlusive dressings unless directed by a physician. Discontinue treatment when control is achieved. Avoid application of Duobrii Lotion on the face, groin, or in the axillae.

    Clinical Results

    FDA Approval

    The FDA approval of Duobrii was based on three studies. 

    Studies 1 and 2, which enrolled a total of 418 patients, showed Duobrii was consistently more effective than vehicle in achieving treatment success (primary endpoint at eight weeks), demonstrating statistically significant superiority by week four (in Study 1) and week two (in Study 2). At week eight, 36 percent (Study 1) and 45 percent (Study 2) had achieved the primary efficacy outcome, compared to seven percent and 13 percent on vehicle (both p<0.001). The majority of responders maintained treatment success over the four-week post treatment period. A third Phase 3 multicenter, open-label study assessed the long term safety of Duobrii over a year in subjects with plaque psoriasis. Patients were given Duobrii once daily for eight weeks and re-evaluated every four weeks after for a year. Continuous treatment was allowed up to 24 weeks and as needed for up to 52 weeks. Treatment related adverse events > two percent were application site reactions such as itching, pain, irritation and inflamed hair follicles (folliculitis).

    Side Effects

    Adverse effects associated with the use of Duobrii may include, but are not limited to, the following:

    contact dermatitis

    application site pain

    folliculitis

    skin atrophy

    excoriation

    Mechanism of Action

    Duobrii is a combination of halobetasol propionate, a corticosteroid and tazarotene, a retinoid prodrug. Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in plaque psoriasis is unknown. Tazarotene is a retinoid prodrug which is converted to its active form, tazarotenic acid, the carboxylic acid of tazarotene, by deesterification. Tazarotenic acid binds to all three members of the retinoic acid receptor (RAR) family: RARα, RARβ and RARγ, but shows relative selectivity for RARβ, and RARγ and may modify gene expression. The clinical significance of these findings for the treatment of plaque psoriasis is unknown. 

    Additional Information

    For additional information regarding Duobrii or plaque psoriasis, please visit https://www.duobrii.com/

    Approval Date: 2019-04-01
    Company Name: Ortho Dermatologics
    Back to Listings

    Upcoming Events

    • 26Jan

      Reducing Complexity in Starting Clinical Trials – More Patients, Faster Startup

    • 27Jan

      Medical Device Clinical Trials in China: Latest Regulatory Developments

    • 11Feb

      Lab X.0: Addressing Quality and Compliance Challenges in Laboratory Operations in the COVID-19 All-Digital Era

    • 23Mar

      Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

    • 26Apr

      MAGI's Clinical Research vConference — Spring 2021

    Featured Products

    • Regenerative Medicine – Steps to Accelerate Development : PDF

      Regenerative Medicine: Steps to Accelerate Development

    • Clinical Trial Agreements — A Guide to Key Words and Phrases : PDF

      Clinical Trial Agreements: A Guide to Key Words and Phrases

    Featured Stories

    • Virtual Doctoer

      Simple Changes Can Make Trials More Patient Friendly

    • Drug approval

      Two-Thirds of Trial Subjects for Drug Approvals Are Outside the U.S.

    • VaccinewithNeedle-360x240.png

      Rules of Vaccine Approval May Be Changing, But Statistical Analysis Tools Remain Constant

    • AskTheExperts-360x240.png

      Ask the Experts: Trial Operations Adjustments in a Remote World

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell My Personal Information

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing