Evaluation of Eflornithine on Facial and Forearm Skin

This study has been completed.
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ClinicalTrials.gov Identifier:
First received: September 8, 2005
Last updated: June 6, 2014
Last verified: September 2007
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 Intervention Phase
Drug: Eflornithine hydrochloride
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by Shire:

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

Secondary Outcome Measures:
  • Skin biopsies
  • Histology and histochemistry in the dermis
  • Physician Global Assessment
  • Subject Self-Assessment Questionnaire

Estimated Enrollment: 78
Study Start Date: November 2004
Study Completion Date: October 2005

Ages Eligible for Study:   18 Years to 85 Years
Genders 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00152048

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

ClinicalTrials.gov Identifier: NCT00152048     History of Changes
Other Study ID Numbers: SPD488-401  2004-000726-78 
Study First Received: September 8, 2005
Last Updated: June 6, 2014
Health Authority: Spain: Ministry of Health and Consumption

Additional relevant MeSH terms:
Anti-Infective Agents
Antineoplastic Agents
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Trypanocidal Agents

ClinicalTrials.gov processed this record on May 02, 2016