Eyebrow HypotrichosisPhase 3NCT01765764
Bimatoprost for the Treatment of Eyebrow Hypotrichosis
A Phase 3 study testing bimatoprost solution in people with Eyebrow Hypotrichosis, run by Allergan at 2 sites in 2 countries.
Trial summary
This study will evaluate the safety and efficacy of bimatoprost solution compared with vehicle in the treatment of eyebrow hypotrichosis (inadequate eyebrows). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eyebrow Hypotrichosis
- What is being tested?
- bimatoprost solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 357 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Mar 2013to 11 Feb 2014
- Phase
- Phase 3
- 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
- -Adult participants with eyebrow hypotrichosis (inadequate eyebrow growth).
Who cannot join
- Patients with disease, infection, or abnormality of the eyebrow area
- Patients with permanent eyebrow loss due to over-grooming
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
This study will evaluate the safety and efficacy of bimatoprost solution compared with vehicle in the treatment of eyebrow hypotrichosis (inadequate eyebrows).
- Conditions
- Eyebrow Hypotrichosis
- Being tested
- bimatoprost solution, Vehicle to bimatoprost solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bimatoprost solutionDrug
Bimatoprost solution once a day or twice a day applied to each eyebrow for 7 months.
Vehicle to bimatoprost solutionDrug
Vehicle to bimatoprost solution once or twice a day applied to each eyebrow for 7 months.
| Study group | Role | What they receive |
|---|---|---|
| Bimatoprost Solution BID | Experimental | Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months. Receives: Drug: bimatoprost solution |
| Bimatoprost Solution QD | Experimental | Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months. Receives: Drug: bimatoprost solution; Drug: Vehicle to bimatoprost solution |
| Vehicle to Bimatoprost Solution BID | Placebo comparator | Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months. Receives: Drug: Vehicle to bimatoprost solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale
The physician evaluated eyebrow fullness using the 4-point GEBA Scale where: 1=very sparse, 2=sparse, 3=full and 4=very full. The percentage of participants with at least a 1-grade increase from Baseline is reported.
Measured: Baseline, Month 7
Secondary outcomes (3)
Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA)
Photographs were taken of the eyebrows. Eyebrow fullness was measured by DMSIA for both eyes and averaged. Eyebrow fullness was reported in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyebrows (improvement).
Measured: Baseline, Month 7
Change From Baseline in Eyebrow Darkness as Measured Using DMSIA
Photographs were taken of the eyebrows. Eyebrow darkness (intensity) was measured by DMSIA for both eyes and averaged. Eyebrow darkness was reported in intensity units. A negative change from Baseline indicated darker eyebrows (improvement).
Measured: Baseline, Month 7
Percentage of Participants With 'Very Satisfied' or 'Mostly Satisfied' in Eyebrow Satisfaction Scale (ESS) Item #6
ESS Item #6 measured the participant's satisfaction with eyebrow treatment: "Overall, how satisfied are you with the way the eyebrow treatment makes your eyebrows look right now?" using a 5-point scale where: 1=very satisfied, 2=mostly satisfied, 3=neither dissatisfied nor satisfied, 4=mostly dissatisfied and 5=very dissatisfied. The percentage of participants 'very satisfied' or 'mostly satisfied' is reported.
Measured: Month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study start13 Mar 2013
- Primary completion31 Jan 2014
- Study completion11 Feb 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eyebrow 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 357 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
- NCT01765764
- Sponsor's protocol ID
- 192024-043
- Status last verified
- Apr 2019
- First submitted
- 9 Jan 2013
- Last updated
- 23 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Carruthers J, Beer K, Carruthers A, Coleman WP 3rd, Draelos ZD, Jones D, Goldman MP, Pucci ML, VanDenburgh A, Weng E, Whitcup SM. Bimatoprost 0.03% for the Treatment of Eyebrow Hypotrichosis. Dermatol Surg. 2016 May;42(5):608-17. doi: 10.1097/DSS.0000000000000755.
PubMed 27124878
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bimatoprost for the Treatment of Eyebrow Hypotrichosis
- ClinicalTrials.gov ID
- NCT01765764
- Acronym / sponsor ID
- 192024-043
- Conditions
- Eyebrow Hypotrichosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2013 (actual)
- Primary completion
- 31 Jan 2014 (actual)
- Study completion
- 11 Feb 2014 (actual)
- First posted
- 10 Jan 2013 (estimated)
- Results
- Posted 26 Jan 2015
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 compared with vehicle in the treatment of eyebrow hypotrichosis (inadequate eyebrows).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bimatoprost Solution BID | Experimental | Drug: bimatoprost solutionBimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months. |
| Bimatoprost Solution QD | Experimental | Drug: bimatoprost solution, Drug: Vehicle to bimatoprost solutionVehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months. |
| Vehicle to Bimatoprost Solution BID | Placebo comparator | Drug: Vehicle to bimatoprost solutionVehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Adult participants with eyebrow hypotrichosis (inadequate eyebrow growth).
Key exclusion criteria (2 listed)
- Patients with disease, infection, or abnormality of the eyebrow area
- Patients with permanent eyebrow loss due to over-grooming
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 solutionBimatoprost solution once a day or twice a day applied to each eyebrow for 7 months. | Drug | Bimatoprost Solution BID, Bimatoprost Solution QD |
| Vehicle to bimatoprost solutionVehicle to bimatoprost solution once or twice a day applied to each eyebrow for 7 months. | Drug | Bimatoprost Solution QD, Vehicle to Bimatoprost Solution BID |
Primary outcome
Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale
Time frame: Baseline, Month 7
The physician evaluated eyebrow fullness using the 4-point GEBA Scale where: 1=very sparse, 2=sparse, 3=full and 4=very full. The percentage of participants with at least a 1-grade increase from Baseline is reported.
3 secondary outcomes
Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA)
Time frame: Baseline, Month 7
Change From Baseline in Eyebrow Darkness as Measured Using DMSIA
Time frame: Baseline, Month 7
Percentage of Participants With 'Very Satisfied' or 'Mostly Satisfied' in Eyebrow Satisfaction Scale (ESS) Item #6
Time frame: Month 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27124878Carruthers J, Beer K, Carruthers A, Coleman WP 3rd, Draelos ZD, Jones D, Goldman MP, Pucci ML, VanDenburgh A, Weng E, Whitcup SM. Bimatoprost 0.03% for the Treatment of Eyebrow Hypotrichosis. Dermatol Surg. 2016 May;42(5):608-17. doi: 10.1097/DSS.0000000000000755.
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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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bimatoprost solution in people with Eyebrow Hypotrichosis, run by Allergan at 2 sites in 2 countries.
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 1 inclusion and 2 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 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 26 Jan 2015). 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 Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale (time frame: Baseline, Month 7). 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 NCT01765764, which also lists 1 linked publication.
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 23 Apr 2019.