HirsutismPhase 4NCT01817894
Treatment With Topical Eflornithin After Laser Treatment in Women With Facial Hirsutism
A Phase 4 study testing Eflornithine cream 11.5 w/w % in people with Hirsutism, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Split-face investigation of the efficacy of applying Eflornithin cream twice daily for six months after a period with six laser treatments for hair removal. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hirsutism
- What is being tested?
- Eflornithine cream 11.5 w/w %
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to Oct 2013
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- habile, understands Danish
- moderate to severe hirsutism prior to laser treatments
- succeeded minimum five laser treatments
- intact skin with no severe adverse events to laser treatments
- record of current medication and androgen hormone blood profile available
- Use of safe anti-conception (fertile women)
Who cannot join
- Pregnant or lactating
- allergy toward the content of Eflornithin cream
- Concomitant use of immunosuppressive therapy
- Dementia, psychiatric disease, alcoholic
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dermatological Dep Bispebjerg Hospital
Copenhagen NV, Copenhagen, 2400
About this study
Split-face investigation of the efficacy of applying Eflornithin cream twice daily for six months after a period with six laser treatments for hair removal.
Read the detailed description
Background: Unwanted facial hair growth is a serious problem for 5-15% of all women winch affects their quality of life. In Denmark patients are offered six laser treatments covered by the public health insurance. There is a lack of good follow-up treatments to this regime that can extent the efficacy of the laser treatment. Eflornithin cream is an approved treatment for reduction of facial hair growth which has proved to give an additional efficiency when used in combination with laser treatments.The efficacy when used after laser hair removal is not known.
Aim: To investigate whether an extended efficacy of laser hair removal can be achieved with application of Eflornithin cream twice daily for six months after completion of laser treatments.
Method: in a split-face trial to apply Eflornithin cream twice daily for six months. Outcome measures are investigator evaluation, blinded on-site evaluation, patient's assessment score and clinical photos.
- Conditions
- Hirsutism
- Being tested
- Eflornithine cream 11.5 w/w %
- Keywords
- Unwanted facial hair growth
- Medical subject headings
- Hirsutism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eflornithine cream 11.5 w/w %Drug
Also called Vaniqa
Split face intervention with application of Eflornithine cream 11.5 w/w % versus no treatment for six months
| Study group | Role | What they receive |
|---|---|---|
| split-face eflornithin vs. no treatment | Other | Eflornithine cream 11.5 W/W% applied twice daily to one side of the face for six months Receives: Drug: Eflornithine cream 11.5 w/w % |
What is being measured
The primary outcome is the main question the study is designed to answer.
blinded photo-evaluation of change in facial hirsutism by hair count in a standardized square field
Measured: baseline, 1, 3 and 6 months
Secondary outcomes (6)
Doctors blinded on-site evaluation of efficacy
Based on a four-point scale used on both sides of the face separately:
- no effect
- small effect (clearly visible hairs on evaluated side)
- large effect (minimal hair on evaluated side)
- significant effect (none or next to no hair on evaluated side)
Measured: Baseline, 1, 3 and 6 months
Patient's overall satisfaction
Based on a VAS scale (0-10)
Measured: Baseline, 1, 3 and 6 months
Patient's assessment of efficacy
Based on a four-point scale used on both sides of the face separately:
- no effect
- small effect (clearly visible hairs on evaluated side)
- large effect (minimal hair on evaluated side)
- significant effect (none or next to no hair on evaluated side)
Measured: Baseline, 1, 3 and 6 months
Patient's assessment of adverse events
Five common side-effects (acne, rash, erythema, changes in pigment, stinging or burning sensation) are evaluated based on a four-point scale:
- none
- mild
- moderate
- severe Other observed side effects will also be registered and rated
Measured: Baseline, 1, 3 and 6 months
Doctor's on-site blinded assessment of adverse events
Five common side-effects (acne, rash, erythema, changes in pigment, stinging or burning sensation) are evaluated based on a four-point scale:
- none
- mild
- moderate
- severe Other observed side effects will also be registered and rated
Measured: Baseline, 1,3 and 6 months
Patient's overall impression of efficacy
Assessment of the patients impression of difference between two sides of the face on a four-point scale:
- No difference
- little difference
- large difference
- significant difference, complete or almost complete clearance of hair on treated side.
Measured: Baseline, 1,3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startJan 2012
- Primary completionOct 2013
- Study completionOct 2013
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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabeth Taudorf, Bispebjerg Hospital
- Investigators
- Elisabeth H Taudorf, MD, Principal investigator, BispbejergH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817894
- Sponsor's protocol ID
- H-2-2011-139
- Status last verified
- Nov 2013
- First submitted
- 14 Feb 2013
- Last updated
- 2 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Topical Eflornithin After Laser Treatment in Women With Facial Hirsutism
- ClinicalTrials.gov ID
- NCT01817894
- Acronym / sponsor ID
- H-2-2011-139
- Conditions
- Hirsutism
- Keywords
- Unwanted facial hair growth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 26 Mar 2013 (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.
Split-face investigation of the efficacy of applying Eflornithin cream twice daily for six months after a period with six laser treatments for hair removal.
Detailed description
Background: Unwanted facial hair growth is a serious problem for 5-15% of all women winch affects their quality of life. In Denmark patients are offered six laser treatments covered by the public health insurance. There is a lack of good follow-up treatments to this regime that can extent the efficacy of the laser treatment. Eflornithin cream is an approved treatment for reduction of facial hair growth which has proved to give an additional efficiency when used in combination with laser treatments.The efficacy when used after laser hair removal is not known.
Aim: To investigate whether an extended efficacy of laser hair removal can be achieved with application of Eflornithin cream twice daily for six months after completion of laser treatments.
Method: in a split-face trial to apply Eflornithin cream twice daily for six months. Outcome measures are investigator evaluation, blinded on-site evaluation, patient's assessment score and clinical photos.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| split-face eflornithin vs. no treatment | Other | Drug: Eflornithine cream 11.5 w/w %Eflornithine cream 11.5 W/W% applied twice daily to one side of the face for six months |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years or older
- habile, understands Danish
- moderate to severe hirsutism prior to laser treatments
- succeeded minimum five laser treatments
- intact skin with no severe adverse events to laser treatments
Key exclusion criteria (4 listed)
- Pregnant or lactating
- allergy toward the content of Eflornithin cream
- Concomitant use of immunosuppressive therapy
- Dementia, psychiatric disease, alcoholic
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 cream 11.5 w/w %Also: VaniqaSplit face intervention with application of Eflornithine cream 11.5 w/w % versus no treatment for six months | Drug | split-face eflornithin vs. no treatment |
Primary outcome
blinded photo-evaluation of change in facial hirsutism by hair count in a standardized square field
Time frame: baseline, 1, 3 and 6 months
6 secondary outcomes
Doctors blinded on-site evaluation of efficacy
Time frame: Baseline, 1, 3 and 6 months
Patient's overall satisfaction
Time frame: Baseline, 1, 3 and 6 months
Patient's assessment of efficacy
Time frame: Baseline, 1, 3 and 6 months
Patient's assessment of adverse events
Time frame: Baseline, 1, 3 and 6 months
Doctor's on-site blinded assessment of adverse events
Time frame: Baseline, 1,3 and 6 months
Patient's overall impression of efficacy
Time frame: Baseline, 1,3 and 6 months
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 2 Dec 2013.
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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.
Elisabeth H Taudorf, MD principal investigator
BispbejergH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eflornithine cream 11.5 w/w % in people with Hirsutism, run by Bispebjerg Hospital at 1 site in Denmark.
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 7 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 2 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
blinded photo-evaluation of change in facial hirsutism by hair count in a standardized square field (time frame: baseline, 1, 3 and 6 months). 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 2 Dec 2013.