Evaluation of Eflornithine on Facial & Forearm Skin NCT00152048

Updated 06/21/2024

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00152048
Other study ID #	SPD488-401
Secondary ID	2004-000726-78
Status	Completed
Phase	Phase 4
First received
Last updated
Start date	November 30, 2004
Est. completion date	October 31, 2005

Study information
Verified date	October 2019
Source	Allergan
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Interventional

Clinical Trial 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

Recruitment information / eligibility
Status	Completed
Enrollment	78
Est. completion date	October 31, 2005
Est. primary completion date
Accepts healthy volunteers	No
Gender	Female
Age group	18 Years to 85 Years
Eligibility	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

Related Conditions & MeSH terms

Hirsutism

Intervention

Drug:
• Eflornithine hydrochloride

Locations
Country	Name	City	State
n/a

Sponsors *(1)*
Lead Sponsor	Collaborator
Allergan

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Change in facial skin thickness measured by ultrasound at 24 weeks
Secondary	Skin biopsies
Secondary	Histology and histochemistry in the dermis
Secondary	Physician Global Assessment
Secondary	Subject Self-Assessment Questionnaire

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