Evaluation of Eflornithine on Facial and Forearm Skin

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00152048

Enrollment

Registered

2005-09-09

Start date

2004-11-30

Completion date

2005-10-31

Last updated

2019-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hirsutism

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

Interventions

DRUGEflornithine hydrochloride

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
Change in facial skin thickness measured by ultrasound at 24 weeks	—

Secondary

Measure	Time frame
Skin biopsies	—
Histology and histochemistry in the dermis	—
Physician Global Assessment	—
Subject Self-Assessment Questionnaire	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026