Eyelash HypotrichosisPhase 3NCT01391286
Safety and Efficacy Study of Bimatoprost in Japanese Patients With Chemotherapy-Induced Eyelash Hypotrichosis
A Phase 3 study testing bimatoprost solution 0.03% in people with Eyelash Hypotrichosis, run by Allergan at 1 site in Japan.
Trial summary
This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with vehicle in Japanese adults with hypotrichosis of the eyelashes following chemotherapy treatment. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Eyelash Hypotrichosis
- What is being tested?
- bimatoprost solution 0.03%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteJapan
- Study dates
- 1 Jul 2011to 25 May 2012
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have inadequate eyelashes due to chemotherapy treatment
- Treated for solid tumors such as breast or colorectal cancer in early stages where the cancer has not spread outside the primary organ (eg, stage 1, 2 or 3a for breast cancer)
- Have completed chemotherapy treatment for at least 4 weeks but not more than 24 weeks and all side effects related to chemotherapy are recovered, improved or maintained, with the exception of hair loss
Who cannot join
- Any disease/infection/abnormality of the eye or area around the eye
- Any ocular surgery within 3 months or anticipated need for ocular surgery during the study
- Any permanent eyeliner or implants of any kind or anticipated use of false eyelashes
- Any semi-permanent eyelash tint, dye, curl or eyelash extension application within 3 months
- Use of any over-the-counter eyelash growth product within 6 months or any use of prescription eyelash growth products
- Use of treatments which may affect hair growth (eg, minoxidil) within 6 months except for prior chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Double-masked, Randomized, Parallel-group Study Assessing the Safety and Efficacy of Once-daily Application of Bimatoprost Solution 0.03% Compared to Vehicle to Treat Chemotherapy-induced Hypotrichosis of the Eyelashes in Japanese Subjects
This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with vehicle in Japanese adults with hypotrichosis of the eyelashes following chemotherapy treatment.
- Conditions
- Eyelash Hypotrichosis
- Being tested
- bimatoprost solution 0.03%, bimatoprost vehicle solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bimatoprost solution 0.03%Drug
Also called LATISSE®
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
bimatoprost vehicle solutionDrug
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
| Study group | Role | What they receive |
|---|---|---|
| bimatoprost solution 0.03% | Experimental | One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months. Receives: Drug: bimatoprost solution 0.03% |
| bimatoprost vehicle solution | Placebo comparator | One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months. Receives: Drug: bimatoprost vehicle 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 in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)
The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement.
Measured: Baseline, Month 4
Secondary outcomes (3)
Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)
Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement).
Measured: Baseline, Month 4
Change From Baseline in Eyelash Thickness as Measured by DIA
Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyelashes (improvement).
Measured: Baseline, Month 4
Change From Baseline in Eyelash Darkness as Measured by DIA
Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).
Measured: Baseline, Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study start1 Jul 2011
- Primary completion25 May 2012
- Study completion25 May 2012
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 Eyelash 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 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
- NCT01391286
- Sponsor's protocol ID
- 192024-067
- Status last verified
- Apr 2019
- First submitted
- 8 Jul 2011
- Last updated
- 8 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Harii K, Arase S, Tsuboi R, Weng E, Daniels S, VanDenburgh A. Bimatoprost for eyelash growth in Japanese subjects: two multicenter controlled studies. Aesthetic Plast Surg. 2014 Apr;38(2):451-60. doi: 10.1007/s00266-014-0293-7. Epub 2014 Mar 19.
PubMed 24643895
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-masked, Randomized, Parallel-group Study Assessing the Safety and Efficacy of Once-daily Application of Bimatoprost Solution 0.03% Compared to Vehicle to Treat Chemotherapy-induced Hypotrichosis of the Eyelashes in Japanese Subjects
- ClinicalTrials.gov ID
- NCT01391286
- Acronym / sponsor ID
- 192024-067
- Conditions
- Eyelash Hypotrichosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2011 (actual)
- Primary completion
- 25 May 2012 (actual)
- Study completion
- 25 May 2012 (actual)
- First posted
- 12 Jul 2011 (estimated)
- Results
- Posted 9 Jul 2013
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% compared with vehicle in Japanese adults with hypotrichosis of the eyelashes following chemotherapy treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bimatoprost solution 0.03% | Experimental | Drug: bimatoprost solution 0.03%One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months. |
| bimatoprost vehicle solution | Placebo comparator | Drug: bimatoprost vehicle solutionOne drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have inadequate eyelashes due to chemotherapy treatment
- Treated for solid tumors such as breast or colorectal cancer in early stages where the cancer has not spread outside the primary organ (eg, stage 1, 2 or 3a for breast cancer)
- Have completed chemotherapy treatment for at least 4 weeks but not more than 24 weeks and all side effects related to chemotherapy are recovered, improved or maintained, with the exception of hair loss
Key exclusion criteria (6 listed)
- Any disease/infection/abnormality of the eye or area around the eye
- Any ocular surgery within 3 months or anticipated need for ocular surgery during the study
- Any permanent eyeliner or implants of any kind or anticipated use of false eyelashes
- Any semi-permanent eyelash tint, dye, curl or eyelash extension application within 3 months
- Use of any over-the-counter eyelash growth product within 6 months or any use of prescription eyelash growth products
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 solution 0.03%Also: LATISSE®One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months. | Drug | bimatoprost solution 0.03% |
| bimatoprost vehicle solutionOne drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months. | Drug | bimatoprost vehicle solution |
Primary outcome
Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)
Time frame: Baseline, Month 4
The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement.
3 secondary outcomes
Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)
Time frame: Baseline, Month 4
Change From Baseline in Eyelash Thickness as Measured by DIA
Time frame: Baseline, Month 4
Change From Baseline in Eyelash Darkness as Measured by DIA
Time frame: Baseline, Month 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24643895Harii K, Arase S, Tsuboi R, Weng E, Daniels S, VanDenburgh A. Bimatoprost for eyelash growth in Japanese subjects: two multicenter controlled studies. Aesthetic Plast Surg. 2014 Apr;38(2):451-60. doi: 10.1007/s00266-014-0293-7. Epub 2014 Mar 19.
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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 3 study testing bimatoprost solution 0.03% in people with Eyelash Hypotrichosis, run by Allergan at 1 site in Japan.
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 6 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 8 Jul 2019. 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 Japan. 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 9 Jul 2013). 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 in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA) (time frame: Baseline, Month 4). 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 NCT01391286, 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 8 Jul 2019.