Evaluation of Eflornithine on Facial and Forearm Skin

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00152048
First received: September 8, 2005
Last updated: June 6, 2014
Last verified: September 2007
  Purpose
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
Hirsutism
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
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152048

Sponsors and Collaborators
Shire
Investigators
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:
Hirsutism
Hair Diseases
Skin Diseases
Virilism
Signs and Symptoms
Eflornithine
Antineoplastic Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Ornithine Decarboxylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 24, 2016