HirsutismPhase 4NCT00152048
Evaluation of Eflornithine on Facial and Forearm Skin
A Phase 4 study testing Eflornithine hydrochloride in people with Hirsutism, run by Allergan.
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 Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Hirsutism
- What is being tested?
- Eflornithine hydrochloride
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2004to 31 Oct 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or lactating women
- Severe inflammatory acne or presence of significant scarring on the face
- History of skin malignancy
- Connective tissue disorders
About this study
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
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
- Conditions
- Hirsutism
- Being tested
- Eflornithine hydrochloride
- Medical subject headings
- Hirsutism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eflornithine hydrochlorideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in facial skin thickness measured by ultrasound at 24 weeks
Secondary outcomes (4)
Skin biopsies
Histology and histochemistry in the dermis
Physician Global Assessment
Subject Self-Assessment Questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study start30 Nov 2004
- Study completion31 Oct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HirsutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 78 participants
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152048
- Sponsor's protocol ID
- SPD488-401
- Other IDs
- 2004-000726-78, 2004
- Status last verified
- Oct 2019
- First submitted
- 8 Sep 2005
- Last updated
- 30 Oct 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00152048
- Acronym / sponsor ID
- SPD488-401
- Conditions
- Hirsutism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2004 (actual)
- Study completion
- 31 Oct 2005 (actual)
- First posted
- 9 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnant or lactating women
- Severe inflammatory acne or presence of significant scarring on the face
- History of skin malignancy
- Connective tissue disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eflornithine hydrochloride | Drug | – |
Primary outcome
Change in facial skin thickness measured by ultrasound at 24 weeks
4 secondary outcomes
Skin biopsies
Histology and histochemistry in the dermis
Physician Global Assessment
Subject Self-Assessment Questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eflornithine hydrochloride in people with Hirsutism, run by Allergan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in facial skin thickness measured by ultrasound at 24 weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019.