HypotrichosisPhase 4NCT01387906
Latisse (Bimatoprost .03% Opthalmic Solution) for the Treatment of Hypotrichosis of the Eyebrows: Latisse Versus Placebo
A Phase 4 study testing topical bimatoprost in people with Hypotrichosis, run by Kenneth Beer at 1 site in United States.
Trial summary
The primary purpose of this study is to assess efficacy and safety of Latisse (bimatoprost .03% ophthalmic solution) applied to the lateral and medial eyebrows. The primary outcome is a increase in overall eyebrow prominence as measured by at least a 1-grade increase on the Global Eyebrow Assessment (GEyA) scale, from… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypotrichosis
- What is being tested?
- topical bimatoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jun 2012
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Outpatient, female/male subjects of any race, 18-75 years of age.
- Subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study
- Patients with hypotrichosis (thinning) of the eyebrows with a GEyA score of 1 or 2.
- Patient agrees to abstain from any treatment to the eyebrows including: waxing, plucking, threading, laser hair removal, and/or bleaching (excluding the glabella region).
- Able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization forms.
- Written informed consent and written authorization for use or release of health and research information obtained.
- Willing to complete all required study visits, procedures, and evaluations including photography.
Who cannot join
- Subjects who are pregnant (positive urine pregnancy test), planning to become pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
- Patients with any uncontrolled systemic disease
- Patient with any known disease or abnormality of the eyebrows including eczema and seborrheic dermatitis
- Patients with known or suspected trichotillomania disorder
- Patients with a history of glaucoma and/or increased ocular pressure
- Patients who are currently using an IOP-lowering prostaglandin analog (including Lumigan)
Show all 12Show fewer
- Patients with a known hypersensitivity to bimatoprost or any other ingredient in Latisse
- Previous cosmetic surgery to the upper face (e.g., periorbital surgery, brow lift, eyelid or eyebrow surgery, etc.).
- Patients with permanent eye and/or eyebrow make-up
- Any eyebrow tint or dye applications within 2 months prior to study entry
- Any planned facial cosmetic procedure that would interfere with the evaluation of the eyebrows
- Participation in another investigational drug or device study within the last 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Kenneth R. Beer, M.D. ,PA
West Palm Beach, Florida, 33401
About this study
Official title: Latisse(Bimatoprost .03% Opthalmic Solution) for the Treatment of Hypotrichosis of the Eyebrows: Latisse Versus Placebo
The primary purpose of this study is to assess efficacy and safety of Latisse (bimatoprost .03% ophthalmic solution) applied to the lateral and medial eyebrows. The primary outcome is a increase in overall eyebrow prominence as measured by at least a 1-grade increase on the Global Eyebrow Assessment (GEyA) scale, from baseline to the end of the treatment which will be day 270 period.
- Conditions
- Hypotrichosis
- Being tested
- topical bimatoprost
- Keywords
- mild, moderate
- Medical subject headings
- Hypotrichosis, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical bimatoprostDrug
Also called bimatoprost, Latisse, eyebrows
topical bimatoprost will be applied one drop to each eyebrow each night.
| Study group | Role | What they receive |
|---|---|---|
| Topical bimatoprost for eyebrows | Experimental | Topical bimatoprost will be applied to areas of the eyebrow that have diminished eyebrows (hypotrichosis). Receives: Drug: topical bimatoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Latisse applied to the lateral and medial eyebrow
Increase in overall eyebrow prominence as measured by at least a 1-grade increase on the Global Eyebrow Assessment (GEyA) scale, from baseline to the end of the treatment which will be day 270 period.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypotrichosisStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenneth Beer
- Collaborators
- Allergan
- Responsible party
- Sponsor-investigator, Kenneth Beer, Beer, Kenneth R., M.D., PA
- Investigators
- Kenneth Beer, M.D., Principal investigator, Beer, Kenneth R., M.D., PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387906
- Sponsor's protocol ID
- Latisse2010
- Status last verified
- Jun 2012
- First submitted
- 1 Jul 2011
- Last updated
- 15 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Law SK. Bimatoprost in the treatment of eyelash hypotrichosis. Clin Ophthalmol. 2010 Apr 26;4:349-58. doi: 10.2147/opth.s6480.
PubMed 20463804Bimatoprost 0.03% solution (latisse) for eyelash enhancement. Med Lett Drugs Ther. 2009 Jun 1;51(1313):43-4. No abstract available.
PubMed 19478690
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latisse(Bimatoprost .03% Opthalmic Solution) for the Treatment of Hypotrichosis of the Eyebrows: Latisse Versus Placebo
- ClinicalTrials.gov ID
- NCT01387906
- Acronym / sponsor ID
- Latisse2010
- Conditions
- Hypotrichosis
- Keywords
- mild, moderate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kenneth Beer
- Collaborators
- Allergan
- Study start
- Mar 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 6 Jul 2011 (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 primary purpose of this study is to assess efficacy and safety of Latisse (bimatoprost .03% ophthalmic solution) applied to the lateral and medial eyebrows. The primary outcome is a increase in overall eyebrow prominence as measured by at least a 1-grade increase on the Global Eyebrow Assessment (GEyA) scale, from baseline to the end of the treatment which will be day 270 period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topical bimatoprost for eyebrows | Experimental | Drug: topical bimatoprostTopical bimatoprost will be applied to areas of the eyebrow that have diminished eyebrows (hypotrichosis). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Outpatient, female/male subjects of any race, 18-75 years of age.
- Subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study
- Patients with hypotrichosis (thinning) of the eyebrows with a GEyA score of 1 or 2.
- Patient agrees to abstain from any treatment to the eyebrows including: waxing, plucking, threading, laser hair removal, and/or bleaching (excluding the glabella region).
- Able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization forms.
Key exclusion criteria (12 listed)
- Subjects who are pregnant (positive urine pregnancy test), planning to become pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
- Patients with any uncontrolled systemic disease
- Patient with any known disease or abnormality of the eyebrows including eczema and seborrheic dermatitis
- Patients with known or suspected trichotillomania disorder
- Patients with a history of glaucoma and/or increased ocular pressure
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 |
|---|---|---|
| topical bimatoprostAlso: bimatoprost, Latisse, eyebrowstopical bimatoprost will be applied one drop to each eyebrow each night. | Drug | Topical bimatoprost for eyebrows |
Primary outcome
Efficacy of Latisse applied to the lateral and medial eyebrow
Time frame: 10 months
Increase in overall eyebrow prominence as measured by at least a 1-grade increase on the Global Eyebrow Assessment (GEyA) scale, from baseline to the end of the treatment which will be day 270 period.
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 15 Jun 2012.
- Background: PubMed 20463804Law SK. Bimatoprost in the treatment of eyelash hypotrichosis. Clin Ophthalmol. 2010 Apr 26;4:349-58. doi: 10.2147/opth.s6480.
- Background: PubMed 19478690Bimatoprost 0.03% solution (latisse) for eyelash enhancement. Med Lett Drugs Ther. 2009 Jun 1;51(1313):43-4. No abstract available.
- eyebrows, bimatoprost, hypotrichosisLink provided by the sponsor.
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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.
Kenneth Beer, M.D. principal investigator
Beer, Kenneth R., M.D., PA
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 topical bimatoprost in people with Hypotrichosis, run by Kenneth Beer at 1 site in United States.
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 12 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 15 Jun 2012. 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 United States. 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?
Efficacy of Latisse applied to the lateral and medial eyebrow (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01387906, which also lists 2 linked publications.
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 15 Jun 2012.