Evaluation of Eflornithine on Facial and Forearm Skin

Allergan

Status and phase: Completed; Phase 4

Conditions: Hirsutism

Treatments: Drug: Eflornithine hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00152048

SPD488-401

2004-000726-78 (EudraCT Number)

Details and patient eligibility

About

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

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind