Evaluation of Eflornithine on Facial and Forearm Skin
October 28, 2019 updated by: Allergan
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
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
Study Overview
Study Type
Interventional
Enrollment
78
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female subjects with clinical diagnosis of facial hirsutism/excessive facial hair
- Women of childbearing potential must agree to use an effective form of birth control for the duration of the study
- Skin type I-IV
- Customary frequency of removal of facial hair two or more times per week
Exclusion Criteria:
- Pregnant or lactating women
- Severe inflammatory acne or presence of significant scarring on the face
- History of skin malignancy
- Connective tissue disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Change in facial skin thickness measured by ultrasound at 24 weeks
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Secondary Outcome Measures
Outcome Measure |
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Skin biopsies
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Histology and histochemistry in the dermis
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Physician Global Assessment
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Subject Self-Assessment Questionnaire
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 30, 2004
Study Completion (Actual)
October 31, 2005
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 8, 2005
First Posted (Estimate)
September 9, 2005
Study Record Updates
Last Update Posted (Actual)
October 30, 2019
Last Update Submitted That Met QC Criteria
October 28, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPD488-401
- 2004-000726-78 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.