Evaluation of Eflornithine on Facial and Forearm Skin

Phase 4CompletedNCT00152048

Allergan78 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hirsutism

Interventions

Eflornithine hydrochlorideDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in facial skin thickness measured by ultrasound at 24 weeks

Secondary Outcomes

Skin biopsies

Histology and histochemistry in the dermis

Physician Global Assessment

Subject Self-Assessment Questionnaire

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.