Back to resultsEvaluation of Eflornithine on Facial and Forearm Skin
Primary Purpose
Hirsutism
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Eflornithine hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Hirsutism
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Change in facial skin thickness measured by ultrasound at 24 weeks
Secondary Outcome Measures
Skin biopsies
Histology and histochemistry in the dermis
Physician Global Assessment
Subject Self-Assessment Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00152048
Brief Title
Evaluation of Eflornithine on Facial and Forearm Skin
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 30, 2004 (Actual)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 31, 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hirsutism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
78 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Eflornithine hydrochloride
Primary Outcome Measure Information:
Title
Change in facial skin thickness measured by ultrasound at 24 weeks
Secondary Outcome Measure Information:
Title
Skin biopsies
Title
Histology and histochemistry in the dermis
Title
Physician Global Assessment
Title
Subject Self-Assessment Questionnaire
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Eflornithine on Facial and Forearm Skin
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