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Evaluation of Eflornithine on Facial and Forearm Skin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00152048
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : June 9, 2014
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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

Condition or disease Intervention/treatment Phase
Hirsutism Drug: Eflornithine hydrochloride Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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
Study Start Date : November 2004
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change in facial skin thickness measured by ultrasound at 24 weeks

Secondary Outcome Measures :
  1. Skin biopsies
  2. Histology and histochemistry in the dermis
  3. Physician Global Assessment
  4. Subject Self-Assessment Questionnaire

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00152048

Sponsors and Collaborators
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Principal Investigator: Professor Jean-Paul Ortonne Hopital L'Archet 2 Service de Dermatologie

Layout table for additonal information Identifier: NCT00152048     History of Changes
Other Study ID Numbers: SPD488-401
2004-000726-78 ( EudraCT Number )
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: June 9, 2014
Last Verified: September 2007
Additional relevant MeSH terms:
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Hair Diseases
Skin Diseases
Signs and Symptoms
Antineoplastic Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Ornithine Decarboxylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action