Eyelash HypotrichosisPhase 4NCT01229423
Safety and Efficacy of LATISSE® in the Augmentation of Eyelashes of Korean Subjects
A Phase 4 study testing bimatoprost 0.03% in people with Eyelash Hypotrichosis, run by Allergan at 1 site in South Korea.
Trial summary
This study will evaluate the safety and efficacy of LATISSE® (bimatoprost 0.03%) in the augmentation of eyelashes in Korean women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Eyelash Hypotrichosis
- What is being tested?
- bimatoprost 0.03%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2009to Oct 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eyelash prominence assessment of minimal or moderate
- Of Korean ethnicity
Who cannot join
- Any eye disease or abnormality
- Any ocular surgery or use of any eyelash extension or eyelash growth products within 3 months
- Any permanent eyeliner within 5 years
- Eyelash implants of any kind
- Eyelash tint or dye application within 2 months
- Use of any treatment that may affect hair growth within 6 months
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the safety and efficacy of LATISSE® (bimatoprost 0.03%) in the augmentation of eyelashes in Korean women.
- Conditions
- Eyelash Hypotrichosis
- Being tested
- bimatoprost 0.03%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bimatoprost 0.03%Drug
Also called LATISSE®
One drop of bimatoprost 0.03% (LATISSE®) applied evenly to each upper eyelid in the evening. Treatment is once daily for up to 40 weeks.
| Study group | Role | What they receive |
|---|---|---|
| LATISSE® | Experimental | bimatoprost 0.03% (LATISSE®) Receives: Drug: bimatoprost 0.03% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Eyelash Length at Week 20
Change from baseline in eyelash length at Week 20. Measurements made were based on the mean length of the upper left and right eyelashes. A positive change from baseline indicates an increase in eyelash length, and a negative change from baseline indicates a decrease in eyelash length.
Measured: Baseline, Week 20
Secondary outcomes (5)
Percentage of Subjects With an Improvement of at Least 1-Point in Global Eyelash Assessment (GEA) Score at Week 20
Percentage of subjects with an improvement of at least 1-point in GEA score at Week 20 from baseline. The GEA scale is an investigator-graded 4-point scale of overall eyelash prominence where 1=minimal, 2=moderate, 3=marked, and 4=very marked prominence.
Measured: Week 20
Change From Baseline in Eyelash Thickness at Week 20
Change from baseline in eyelash thickness at Week 20. Assessments made were based on the mean thickness of the upper left and right eyelashes. A positive change from baseline indicates an increase in eyelash thickness, and a negative change from baseline indicates a decrease in eyelash thickness.
Measured: Baseline, Week 20
Change From Baseline in Eyelash Intensity (Darkness) at Week 20
Change from baseline in eyelash intensity (darkness) at Week 20. Assessments made were based on the mean eyelash intensity of the upper left and right eyelashes. Intensity was measured on a scale ranging from 0 (black) to 255 (white). A negative change from baseline indicates eyelash darkening in color, and a positive change from baseline indicates eyelash lightening in color.
Measured: Baseline, Week 20
Percentage of Subjects With an Improvement in Satisfaction With Overall Eyelash Prominence at Week 20
Percentage of subjects with an improvement in satisfaction with overall eyelash prominence at Week 20. Subject satisfaction with overall eyelash prominence was assessed by response to the question "Overall how satisfied are you with your eyelashes?" Responses were based on a 5-point scale ("very unsatisfied", "unsatisfied", "neutral", "satisfied", "very satisfied"). Improvement in subject satisfaction is defined as a 1-point increase from baseline.
Measured: Week 20
Percentage of Subjects Satisfied With Treatment at Week 20
Percentage of subjects satisfied with treatment at week 20 was assessed using the Treatment Satisfaction Scale response to the question "Which best describes your satisfaction with LATISSE®?" Responses were "very satisfied", "satisfied", "neutral", "unsatisfied", and "very unsatisfied." Satisfied is defined as responses of "very satisfied" and "satisfied."
Measured: Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2010 (estimated)
- Study startNov 2009
- Primary completionJun 2010
- Study completionOct 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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 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
- NCT01229423
- Sponsor's protocol ID
- LAT-KOR-01
- Status last verified
- Jan 2019
- First submitted
- 25 Oct 2010
- Last updated
- 29 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kwon O, Kim JY, Paik SH, Jeon HC, Jung YJ, Lee Y, Baek JH, Chun JH, Lee WS, Lee JY, Rogers JD, Halstead M, Eun HC. Long-term utility and durability of the therapeutic effects of bimatoprost 0.03% for eyelash augmentation in healthy Asian subjects. Dermatology. 2014;229(3):222-9. doi: 10.1159/000363379. Epub 2014 Sep 6.
PubMed 25228046
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of LATISSE® in the Augmentation of Eyelashes of Korean Subjects
- ClinicalTrials.gov ID
- NCT01229423
- Acronym / sponsor ID
- LAT-KOR-01
- Conditions
- Eyelash Hypotrichosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 27 Oct 2010 (estimated)
- Results
- Posted 23 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 LATISSE® (bimatoprost 0.03%) in the augmentation of eyelashes in Korean women.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LATISSE® | Experimental | Drug: bimatoprost 0.03%bimatoprost 0.03% (LATISSE®) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eyelash prominence assessment of minimal or moderate
- Of Korean ethnicity
Key exclusion criteria (6 listed)
- Any eye disease or abnormality
- Any ocular surgery or use of any eyelash extension or eyelash growth products within 3 months
- Any permanent eyeliner within 5 years
- Eyelash implants of any kind
- Eyelash tint or dye application within 2 months
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 0.03%Also: LATISSE®One drop of bimatoprost 0.03% (LATISSE®) applied evenly to each upper eyelid in the evening. Treatment is once daily for up to 40 weeks. | Drug | LATISSE® |
Primary outcome
Change From Baseline in Eyelash Length at Week 20
Time frame: Baseline, Week 20
Change from baseline in eyelash length at Week 20. Measurements made were based on the mean length of the upper left and right eyelashes. A positive change from baseline indicates an increase in eyelash length, and a negative change from baseline indicates a decrease in eyelash length.
5 secondary outcomes
Percentage of Subjects With an Improvement of at Least 1-Point in Global Eyelash Assessment (GEA) Score at Week 20
Time frame: Week 20
Change From Baseline in Eyelash Thickness at Week 20
Time frame: Baseline, Week 20
Change From Baseline in Eyelash Intensity (Darkness) at Week 20
Time frame: Baseline, Week 20
Percentage of Subjects With an Improvement in Satisfaction With Overall Eyelash Prominence at Week 20
Time frame: Week 20
Percentage of Subjects Satisfied With Treatment at Week 20
Time frame: Week 20
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25228046Kwon O, Kim JY, Paik SH, Jeon HC, Jung YJ, Lee Y, Baek JH, Chun JH, Lee WS, Lee JY, Rogers JD, Halstead M, Eun HC. Long-term utility and durability of the therapeutic effects of bimatoprost 0.03% for eyelash augmentation in healthy Asian subjects. Dermatology. 2014;229(3):222-9. doi: 10.1159/000363379. Epub 2014 Sep 6.
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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 0.03% in people with Eyelash Hypotrichosis, run by Allergan at 1 site in South Korea.
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 2 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 29 Jan 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 South Korea. 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?
Yes. Results are posted in the registry (first posted 23 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?
Change From Baseline in Eyelash Length at Week 20 (time frame: Baseline, Week 20). 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 NCT01229423, 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 29 Jan 2019.