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Evaluation of Eflornithine on Facial and Forearm Skin

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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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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