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Completed

NCT Number: NCT00152048

Evaluation of Eflornithine on Facial and Forearm Skin

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

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Key information

Conditions

Hirsutism Hair Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Virilism

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eflornithine hydrochloride

Drug

Primary outcomes

  1. Change in facial skin thickness measured by ultrasound at 24 weeks

Secondary outcomes

  1. Skin biopsies

  2. Histology and histochemistry in the dermis

  3. Physician Global Assessment

  4. Subject Self-Assessment Questionnaire

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2005
First posted
Sep 9, 2005
Registry last updated
Oct 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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