Trial · NCT01023841
Safety and Efficacy of Bimatoprost Solution in Treating Eyelash Loss or Hypotrichosis in Children
NCT01023841, Phase 4, Completed, Allergan; results first posted 2013-09-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Bimatoprost Solution in Treating Eyelash Loss or Hypotrichosis in Children. Trials, record NCT01023841. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01023841
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Bimatoprost Solution in Treating Eyelash Loss or Hypotrichosis in Children
- NCT number
- NCT01023841
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 71 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Eyelash Hypotrichosis, Alopecia Areata
- Interventions
- bimatoprost ophthalmic solution 0.03%, Vehicle Sterile Solution
- First posted
- 2009-12-02
- Last updated
- 2019-04-17
- Results first posted
- 2013-09-13
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events | 5 Months | An adverse event was any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. |
| Primary | Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Global Eyebrow Assessment (GEA) Score | Baseline, Month 4 | The physician evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement. |
| Secondary | Change From Baseline Upper Eyelash Length as Measured by Digital Image Analysis (DIA) | Baseline, Month 4 | 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). |
| Secondary | Change From Baseline in Upper Eyelash Thickness as Measured by DIA | Baseline, Month 4 | 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). |
| Secondary | Change From Baseline in Upper Eyelash Darkness as Measured by DIA | Baseline, Month 4 | Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness (intensity) 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). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Adverse Events | 5 Months | Safety population included all randomized participants who received treatment. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline Upper Eyelash Length as Measured by Digital Image Analysis (DIA) | Baseline, Month 4 | Intent-to-treat population included all randomized participants. | mm | MEAN |
| SECONDARY | Change From Baseline in Upper Eyelash Thickness as Measured by DIA | Baseline, Month 4 | Participants from the Intent-to-treat population, that included all randomized participants, with data available at Baseline and Month 4. | mm^2 | MEAN |
| SECONDARY | Change From Baseline in Upper Eyelash Darkness as Measured by DIA | Baseline, Month 4 | Participants from the Intent-to-treat population, that included all randomized participants, with data available at Baseline and Month 4. | Intensity units | MEAN |
| PRIMARY | Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Global Eyebrow Assessment (GEA) Score | Baseline, Month 4 | Intent-to-treat population included all randomized participants. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Adverse Events | Bimatoprost Ophthalmic Solution 0.03% | 35.4 | Percentage of participants | ||
| Percentage of Participants With Adverse Events | Vehicle Sterile Solution | 43.5 | Percentage of participants | ||
| Change From Baseline Upper Eyelash Length as Measured by Digital Image Analysis (DIA) | Bimatoprost Ophthalmic Solution 0.03% | Baseline | 6.83 | Standard Deviation 2.568 | mm |
| Change From Baseline Upper Eyelash Length as Measured by Digital Image Analysis (DIA) | Vehicle Sterile Solution | Baseline | 6.04 | Standard Deviation 2.915 | mm |
| Change From Baseline Upper Eyelash Length as Measured by Digital Image Analysis (DIA) | Bimatoprost Ophthalmic Solution 0.03% | Change from Baseline at Month 4 | 1.12 | Standard Deviation 1.626 | mm |
| Change From Baseline Upper Eyelash Length as Measured by Digital Image Analysis (DIA) | Vehicle Sterile Solution | Change from Baseline at Month 4 | 0.67 | Standard Deviation 1.846 | mm |
| Change From Baseline in Upper Eyelash Thickness as Measured by DIA | Bimatoprost Ophthalmic Solution 0.03% | Baseline | 1.20 | Standard Deviation 0.738 | mm^2 |
| Change From Baseline in Upper Eyelash Thickness as Measured by DIA | Vehicle Sterile Solution | Baseline | 1.18 | Standard Deviation 0.862 | mm^2 |
| Change From Baseline in Upper Eyelash Thickness as Measured by DIA | Bimatoprost Ophthalmic Solution 0.03% | Change from Baseline at Month 4 | 0.41 | Standard Deviation 0.535 | mm^2 |
| Change From Baseline in Upper Eyelash Thickness as Measured by DIA | Vehicle Sterile Solution | Change from Baseline at Month 4 | 0.05 | Standard Deviation 0.449 | mm^2 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bimatoprost Ophthalmic Solution 0.03% | 48 | |
| Overall Study | STARTED | Vehicle Sterile Solution | 23 | |
| Overall Study | COMPLETED | Bimatoprost Ophthalmic Solution 0.03% | 47 | |
| Overall Study | COMPLETED | Vehicle Sterile Solution | 23 | |
| Overall Study | NOT COMPLETED | Bimatoprost Ophthalmic Solution 0.03% | 1 | |
| Overall Study | NOT COMPLETED | Vehicle Sterile Solution | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ovarian cyst ruptured | Reproductive system and breast disorders | Bimatoprost Ophthalmic Solution 0.03% | 0 | 37 | |
| other | Ovarian cyst ruptured | Reproductive system and breast disorders | Vehicle Sterile Solution | 1 | 16 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bimatoprost Ophthalmic Solution 0.03% | ||
| Total, all-cause mortality | Vehicle Sterile Solution | ||
| Total, other adverse events | Bimatoprost Ophthalmic Solution 0.03% | 0 | 48 |
| Total, other adverse events | Vehicle Sterile Solution | 1 | 23 |
| Total, serious adverse events | Bimatoprost Ophthalmic Solution 0.03% | 0 | 48 |
| Total, serious adverse events | Vehicle Sterile Solution | 0 | 23 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27022239 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Bimatoprost Ophthalmic Solution 0.03% vs Vehicle Sterile Solution: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01023841
GET https://conductscience.org/api/trials/v1/NCT01023841/registered