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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00152048
Other study ID # SPD488-401
Secondary ID 2004-000726-78
Status Completed
Phase Phase 4
First received
Last updated
Start date November 30, 2004
Est. completion date October 31, 2005

Study information

Verified date October 2019
Source Allergan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date October 31, 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Eflornithine hydrochloride


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Allergan

Outcome

Type Measure Description Time frame Safety issue
Primary Change in facial skin thickness measured by ultrasound at 24 weeks
Secondary Skin biopsies
Secondary Histology and histochemistry in the dermis
Secondary Physician Global Assessment
Secondary Subject Self-Assessment Questionnaire
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