Clinical Trial: Evaluation of Eflornithine on Facial and Forearm Skin
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A 24 Week Randomised Double Blind Placebo Controlled Study to Evaluate the Atrophogenic Potential of Eflornithine in the Treatment of Women With Excessive Facial Hair
Brief Summary: The purpose of this study is to evaluate whether regular use of eflornithine 11.5% cream in treating women with facial hair will induce skin damage (atrophy) on the face and/or forearms
Detailed Summary:
Sponsor: Shire
Current Primary Outcome: Change in facial skin thickness measured by ultrasound at 24 weeks
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Skin biopsies
- Histology and histochemistry in the dermis
- Physician Global Assessment
- Subject Self-Assessment Questionnaire
Original Secondary Outcome: Same as current
Information By: Shire
Dates:
Date Received: September 8, 2005
Date Started: November 2004
Date Completion:
Last Updated: June 6, 2014
Last Verified: September 2007