Evaluation of Eflornithine on Facial and Forearm Skin

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00152048
• Collaborator: (none)
• Enrollment: 78
• Actual Duration (Months): 11

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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
• Actual Study Start Date: Nov 30, 2004
• Actual Study Completion Date: Oct 31, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Allergan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT00152048
• Other Study ID Numbers: SPD488-401; 2004-000726-78
• First Posted: Sep 9, 2005
• Last Update Posted: Oct 30, 2019
• Last Verified: Oct 1, 2019

• Additional relevant MeSH terms: Hirsutism; Eflornithine

Study Results

No Results Posted as of Oct 30, 2019