NCT01623479

Brief Summary

This is an observational study of patients treated with bimatoprost 0.03% (Latisse®) for at least 12 months for hypotrichosis of the eyelashes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
585

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
3 months until next milestone

Results Posted

Study results publicly available

September 19, 2012

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

10 months

First QC Date

June 18, 2012

Results QC Date

August 16, 2012

Last Update Submit

April 3, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of Subjects Satisfied With Latisse®

    Overall subject satisfaction with Latisse® was assessed on a 5-point scale (Very Satisfied, Satisfied, Neutral, Unsatisfied, and Very Unsatisfied). The percentage of subjects satisfied and very satisfied is reported.

    Day 1

Secondary Outcomes (2)

  • Number of Applications of Latisse® Per Week

    Day 1

  • Percentage of Subjects Satisfied Wtih Their Eyelashes

    Day 1

Study Arms (1)

Hypotrichosis of the Eyelashes

Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months

Drug: bimatoprost 0.03%

Interventions

Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months

Also known as: Latisse®
Hypotrichosis of the Eyelashes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with hypotrichosis of the eyelashes

You may qualify if:

  • Hypotrichosis of the eyelashes
  • Using bimatoprost ophthalmic solution 0.03% (Latisse®) for at least 12 months

You may not qualify if:

  • Use of any over-the-counter medication(s) for eyelash growth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Santa Ana, California, United States

Location

Related Publications (1)

  • Yoelin SG, Fagien S, Cox SE, Davis PG, Campo A, Caulkins CA, Gallagher CJ. A retrospective review and observational study of outcomes and safety of bimatoprost ophthalmic solution 0.03% for treating eyelash hypotrichosis. Dermatol Surg. 2014 Oct;40(10):1118-24. doi: 10.1097/01.DSS.0000452658.83001.d9.

    PMID: 25229783BACKGROUND

MeSH Terms

Interventions

Bimatoprost

Intervention Hierarchy (Ancestors)

AmidesOrganic ChemicalsCloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Results Point of Contact

Title
Vice President Medical Affairs,
Organization
Allergan, Inc

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2012

First Posted

June 20, 2012

Study Start

November 19, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

April 16, 2019

Results First Posted

September 19, 2012

Record last verified: 2019-04

Locations