• 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
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • 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 » Verdeso (desonide)

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

Verdeso (desonide)

  • Profile

Profile

Contact Information

Contact: Stiefel
Website: http://www.connetics.com/

Currently Enrolling Trials

    Show More

    General Information

    Verdeso (desonide) Foam is a petrolatum-based emulsion aerosol foam containing the active ingredient desonide, a low-potency topical corticosteroid. Desonide is a white powder or crystal that is practically insoluble in water, sparingly soluble in ethanol and in acetone and soluble in chloroform.

    Verdeso is specifically indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.

     

    Mechanism of Action

    Verdeso Foam is a topical corticosteroid that is thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. These proteins are believed to control the biosynthesis of potent mediators of inflammation, such as prostaglandins and leukotrienes, by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

    Side Effects

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

    • Upper respiratory tract infection
    • Cough
    • Application site burning
    • Application site reaction
    • Viral infection
    • Headache
    • Irritability
    • Asthma

    In addition, in a clinical study, Verdeso was shown to cause adrenal suppression in 4 percent of the pediatric subjects after four weeks of use. Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing’s syndrome, hyperglycemia and glucosuria in some patients. Verdeso Foam is contraindicated in subjects who are hypersensitive to desonide or to any ingredient in this preparation. Treatment should not exceed four consecutive weeks.

    Dosing/Administration

    Verdeso is supplied in 100-g aluminum cans. The recommended initial dose of the drug is a thin layer applied to the affected area(s) twice daily. The smallest amount of foam necessary to adequately cover the affected area(s) with a thin layer should be used.

    Clinical Trial Results

    FDA Approval
    FDA approval of Verdeso was based on results of one clinical trial. This double-blind, randomized trial enrolled 581 subjects, ages 3 months to 17 years old, with mild to moderate atopic dermatitis, who received Verdeso Foam applied twice daily for four weeks. Of the subjects on the Verdeso treatment, 39 percent achieved success, defined as an Investigator's Static Global Assessment (ISGA) score of clear or almost clear, a minimum improvement in the five-point ISGA score of two grades from baseline to week four, and a score of absent or minimal for both erythema and induration/papulation at week four. Only 9 percent of the subjects on placebo achieved success.

    Ongoing Study Commitments

    • Connetics has agreed to commit to conducting a dermal carcinogenicity study with Verdeso (desonide) Foam.
      90-day dose range-finding study: by April 1, 2008
      Study protocol submission: by October 1, 2008
      Study start date: by June 1, 2009
      Final report submission: by December 1, 2012
    • Connetics has agreed to commit to conducting a study to determine the photoco-carcinogenic potential of Verdeso (desonide) Foam.
      90-day dose range-finding study: by April 1, 2008
      Study protocol submission: by October 1, 2008
      Study start date: by June 1, 2009
      Final report submission: by December 1, 2011

     

     

    Approval Date: 2006-09-01
    Company Name: Connetics Corporation
    Back to Listings

    Upcoming Events

    • 16Feb

      Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

    • 21May

      WCG MAGI Clinical Research Conference – 2023 East

    Featured Products

    • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

      Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    Featured Stories

    • SurveywBlueBackground-360x240.png

      Sites Name Tech Acceptance as Essential Factor in Selection of Sponsors, Survey Finds

    • TrendsInsights2023-360x240.png

      WCG Clinical Research Trends and Insights for 2023, Part Two

    • TimeMoneyEffort-360x240.png

      Time is Money and So Is Effort, Budgeting Experts Say

    • TrendsInsights2023A-360x240.png

      WCG Clinical Research Trends and Insights for 2023, Part Three

    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 or Share My Data

    Footer Logo

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

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing