HypotrichosisPhase 4NCT00958035
Study of Bimatoprost Solution in Increasing Eyelash Prominence in African Americans With Eyelash Hypotrichosis
A Phase 4 study testing bimatoprost ophthalmic 0.03% solution in people with Hypotrichosis, run by Allergan at 1 site in United States.
Trial summary
This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily to the upper eyelid margins (where the eyelashes meet the skin) compared with vehicle in increasing overall eyelash prominence in self-identified African American/ethnic black subjects exhibiting hypotrichosis of the eyelashes… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotrichosis
- What is being tested?
- bimatoprost ophthalmic 0.03% solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Aug 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African American/ethnic black
- Adults at least 18 years of age
- Eyelash prominence assessment of minimal or moderate
Who cannot join
- Subjects with uneven lashes or longer on one side than the other
- Any eye disease or abnormality
- Eye surgery
- Severe hyperpigmentation around the eye
- Eyelash implants
- Eyelash extension application
Show all 10Show fewer
- Any use of eyelash growth products within 6 months
- Any use of prescription eyelash growth products
- Treatments that may affect hair growth
- Requiring eye drop medications for glaucoma
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily to the upper eyelid margins (where the eyelashes meet the skin) compared with vehicle in increasing overall eyelash prominence in self-identified African American/ethnic black subjects exhibiting hypotrichosis of the eyelashes (inadequate or not enough eyelashes).
- Conditions
- Hypotrichosis
- Being tested
- bimatoprost ophthalmic 0.03% solution, vehicle sterile solution (placebo)
- Medical subject headings
- Hypotrichosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bimatoprost ophthalmic 0.03% solutionDrug
Also called LATISSE®
Apply one drop of study medication along the upper eyelid margin once daily in the evening
vehicle sterile solution (placebo)Drug
Apply one drop of study medication along the upper eyelid margin once daily in the evening
| Study group | Role | What they receive |
|---|---|---|
| LATISSE® | Experimental | bimatoprost ophthalmic 0.03% solution Receives: Drug: bimatoprost ophthalmic 0.03% solution |
| Placebo | Placebo comparator | vehicle sterile solution Receives: Drug: vehicle sterile solution (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4
Percentage of treatment responders in overall eyelash prominence, defined as at least a 1-grade improvement from baseline at Month 4 in the Global Eyelash Assessment (GEA) Scale. The GEA is a 4-point scale in which eyelash prominence is assessed from 1 (minimal prominence) to 4 (very marked prominence).
Measured: Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startNov 2009
- Primary completionJul 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958035
- Sponsor's protocol ID
- 192024-039
- Status last verified
- Nov 2011
- First submitted
- 11 Aug 2009
- Last updated
- 5 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Bimatoprost Solution in Increasing Eyelash Prominence in African Americans With Eyelash Hypotrichosis
- ClinicalTrials.gov ID
- NCT00958035
- Acronym / sponsor ID
- 192024-039
- Conditions
- Hypotrichosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 13 Aug 2009 (estimated)
- Results
- Posted 5 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily to the upper eyelid margins (where the eyelashes meet the skin) compared with vehicle in increasing overall eyelash prominence in self-identified African American/ethnic black subjects exhibiting hypotrichosis of the eyelashes (inadequate or not enough eyelashes).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LATISSE® | Experimental | Drug: bimatoprost ophthalmic 0.03% solutionbimatoprost ophthalmic 0.03% solution |
| Placebo | Placebo comparator | Drug: vehicle sterile solution (placebo)vehicle sterile solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- African American/ethnic black
- Adults at least 18 years of age
- Eyelash prominence assessment of minimal or moderate
Key exclusion criteria (10 listed)
- Subjects with uneven lashes or longer on one side than the other
- Any eye disease or abnormality
- Eye surgery
- Severe hyperpigmentation around the eye
- Eyelash implants
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 |
|---|---|---|
| bimatoprost ophthalmic 0.03% solutionAlso: LATISSE®Apply one drop of study medication along the upper eyelid margin once daily in the evening | Drug | LATISSE® |
| vehicle sterile solution (placebo)Apply one drop of study medication along the upper eyelid margin once daily in the evening | Drug | Placebo |
Primary outcome
Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4
Time frame: Month 4
Percentage of treatment responders in overall eyelash prominence, defined as at least a 1-grade improvement from baseline at Month 4 in the Global Eyelash Assessment (GEA) Scale. The GEA is a 4-point scale in which eyelash prominence is assessed from 1 (minimal prominence) to 4 (very marked prominence).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director study director
Allergan
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 bimatoprost ophthalmic 0.03% solution in people with Hypotrichosis, run by Allergan 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 3 inclusion and 10 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 5 Jan 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 5 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4 (time frame: Month 4). 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 5 Jan 2012.