Evaluation of Eflornithine on Facial and Forearm Skin

Phase 4

Completed

• Conditions: Hirsutism

• Registration Number: NCT00152048
• Lead Sponsor: Allergan

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 Description

Not available

Study Timeline

• Study Start: 2004-11-30
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-09
• Study Completion: 2005-10-31
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-28
• Last Update Posted: 2019-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in facial skin thickness measured by ultrasound at 24 weeks

Secondary Outcome Measures

Name	Time	Method
Skin biopsies
Histology and histochemistry in the dermis
Physician Global Assessment
Subject Self-Assessment Questionnaire