• 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
    • JobWatch
    • 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 » Soolantra (ivermectin) cream, 1%

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

Soolantra (ivermectin) cream, 1%

  • Profile

Profile

Contact Information

Contact: Galderma Laboratories
Website: http://www.soolantra.com/

Currently Enrolling Trials

    Show More

    General Information

    Soolantra (ivermectin) cream is a broad-spectrum antiparasitic agent. The exact mechanism of action by which it works against rosacea is not clear.

    Soolantra is specifically indicated for the treatment of inflammatory lesions of rosacea.

    Mechanism of Action

    Soolantra (ivermectin) cream is a semi-synthetic derivative isolated from the fermentation of Streptomyces avermitilis, which belongs to the avermectin family of macrocyclic lactones. The exact mechanism of action by which it works against rosacea is not clear. 

    Side Effects

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

    • skin burning sensation
    • skin irritation

    Dosing/Administration

    Soolantra is supplied as a cream for topical administration. Soolantra should be applied to the affected areas of the face once daily. Use a pea-size amount for each area of the face (forehead, chin, nose, each cheek) that is affected. Spread as a thin layer, avoiding the eyes and lips.

    Clinical Trial Results

    The FDA approval of Soolantra was based on two identical randomized, double-blind, vehicle-controlled clinical trials. The trials were conducted in 1,371 subjects aged 18 years and older who were treated once daily for 12 weeks with either Soolantra cream or vehicle cream. Using the 5-point Investigator’s Global Assessment (IGA) scale (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe), 79 percent of subjects were scored as moderate (IGA=3) and 21 percent scored as severe (IGA= 4) at baseline. The co-primary efficacy endpoints in both pivotal trials were the success rate based on the IGA outcome (percentage of subjects “clear” and “almost clear”) and absolute change from baseline in inflammatory lesion counts at week 12. Study 1 - IGA outcome: 38.4 percent for Soolantra cream arm versus 11.6 percent for the vehicle arm; inflammatory lesion count: 64.9 percent for the Soolantra cream arm versus 41.6 percent for the vehicle arm. Study 2 - IGA outcome: 40.1 percent for Soolantra cream arm versus 18.8 percent for the vehicle arm; inflammatory lesion count: 65.7 percent for the Soolantra cream arm versus 43.4 percent for the vehicle arm. 

     

    Approval Date: 2014-12-01
    Company Name: Galderma Labs
    Back to Listings

    Upcoming Events

    • 24May

      Powering an Effective Oversight Strategy with Clinical and Operational Insights

    • 25May

      2022 WCG Avoca Quality & Innovation Summit: Own the Future

    • 28Jun

      Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

    • 16Oct

      WCG MAGI's Clinical Research Hybrid Conference - 2022 West

    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

    • Protocol-360x240.png

      Avoid Deviations by Making Protocol Review a Team Effort

    • SelectionProcess-360x240.png

      Give Us a Voice: Sites Clamor for a Say on Vendor Selection

    • Convince-360x240.png

      Use Data and Details to Convince Site Leadership to Add Staff

    • AsktheExpertsBadge-360x240.png

      Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

    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 © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing