ClinicalTrials.gg
CompletedNCT00152048Updated Oct 30, 2019

Evaluation of Eflornithine on Facial and Forearm Skin

A Phase 4 interventional study of Eflornithine hydrochloride in Hirsutism, sponsored by Allergan. Completed. Open to female participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-10-30.

Sponsored by Allergan (part of AbbVie) · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Nov 2004, registered Sep 2005).
Phase
Phase 4
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
Female
01

Study 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

02

Conditions studied

  • Hirsutism

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03

In context

Hirsutism

41 studies on the registry are indexed under Hirsutism; 8 are open to participants now.

This study's enrollment of 78 is above the median of 43 across 26 interventional studies indexed under Hirsutism.

Browse Hirsutism studies →

Lead sponsor

Allergan is the lead sponsor of 505 studies on the registry; none are open to participants now.

Of its 93 completed or terminated interventional studies of FDA-regulated products, 91 (98%) have results posted.

First submitted before Allergan became part of AbbVie.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female subjects with clinical diagnosis of facial hirsutism/excessive facial hair
  • Women of must agree to use an effective form of 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

Exclusion Criteria:

  • Pregnant or lactating women
  • Severe inflammatory acne or presence of significant scarring on the face
  • History of skin
  • Connective tissue disorders
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
78 participants
06

What researchers measure

Primary outcomes

  1. Change in facial skin thickness measured by ultrasound at 24 weeks

Secondary outcomes

  1. Skin biopsies

  2. Histology and histochemistry in the dermis

  3. Physician Global Assessment

  4. Subject Self-Assessment Questionnaire

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2004 (actual).

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2005
First posted
Sep 9, 2005
StartActual
Nov 30, 2004
CompletionActual
Oct 31, 2005
Last update
Oct 30, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00152048
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Sep 9, 2005
Start date
Nov 30, 2004
Completion
Oct 31, 2005
Last update
Oct 30, 2019
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Eflornithine

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