Epidemiologic Analysis of Change in Eyelash Characteristics With Age in Healthy Women

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01518270
• Collaborator: (none)
• Enrollment: 179
• Location: 1
• Actual Duration (Days): 15
• Patients Per Site Per Month: 363.2

Study Details

Study Description

Brief Summary

This study will asses epidemiologic changes in eyelash characteristics with increasing age.

Condition or Disease	Intervention/Treatment	Phase
Health	Other: No treatment

Study Design

• Study Type: Observational
• Actual Enrollment: 179 participants
• Observational Model: Ecologic or Community
• Time Perspective: Prospective
• Actual Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Dec 16, 2011
• Actual Study Completion Date: Dec 16, 2011

Arms and Interventions

Arm	Intervention/Treatment
Healthy Females Healthy Females	Other: No treatment; No treatment will be provided

Outcome Measures

Primary Outcome Measures

1. Eyelash Length as Measured by Digital Image Analysis (DIA) [Baseline]

   Photographs were taken of the eyelashes. Length was measured in millimeters. Data from both eyes were averaged for each participant for analysis.

Secondary Outcome Measures

1. Eyelash Thickness as Measured by Digital Image Analysis (DIA) [Baseline]

   Photographs were taken of the eyelashes. Eyelash thickness/fullness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm^2).

2. Eyelash Darkness as Measured by Digital Image Analysis (DIA) [Baseline]

   Photographs were taken of the Eyelashes. Eyelash darkness (intensity) was measured within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Willing to have photographs taken of the face/eye regions

Exclusion Criteria:

• No visible eyelashes

• Permanent eyeliner or eyelash implants

• Semi-permanent eyelash tint, dye, or extensions within the last 3 months

• Use of prescription eyelash growth products in the last 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Irvine	California	United States

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

• Glaser DA, Jones D, Carruthers J, Campo A, Moench S, Tardie G, Largent J, Caulkins C. Epidemiologic analysis of change in eyelash characteristics with increasing age in a population of healthy women. Dermatol Surg. 2014 Nov;40(11):1208-13. doi: 10.1097/DSS.0000000000000170.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01518270
• Other Study ID Numbers: GMA-LTS-11-003
• First Posted: Jan 25, 2012
• Last Update Posted: May 1, 2019
• Last Verified: Apr 1, 2019

Study Results

Participant Flow

Arm/Group Title	Healthy Females
Arm/Group Description	Participant's eyelashes were photographed at one study visit.
Period Title: Overall Study
STARTED	179
COMPLETED	179
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Healthy Females
Arm/Group Description	Participant's eyelashes were photographed at one study visit.
Overall Participants	179
Age (Years) [Mean (Full Range) ]
Mean (Full Range) [Years]	40.3 (10.3)
Sex: Female, Male (Count of Participants)
Female	179 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

Title	Eyelash Length as Measured by Digital Image Analysis (DIA)
Description	Photographs were taken of the eyelashes. Length was measured in millimeters. Data from both eyes were averaged for each participant for analysis.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All participants with values available.

Arm/Group Title	Healthy Females
Arm/Group Description	Participant's eyelashes were photographed at one study visit.
Measure Participants	177
Mean (Full Range) [Millimeters (mm)]	7.33 (1.15)

2. Secondary Outcome

Title	Eyelash Thickness as Measured by Digital Image Analysis (DIA)
Description	Photographs were taken of the eyelashes. Eyelash thickness/fullness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm^2).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All participants with values available.

Arm/Group Title	Healthy Females
Arm/Group Description	Participant's eyelashes were photographed at one study visit.
Measure Participants	153
Mean (Full Range) [Millimeters squared (mm^2)]	1.39 (0.56)

3. Secondary Outcome

Title	Eyelash Darkness as Measured by Digital Image Analysis (DIA)
Description	Photographs were taken of the Eyelashes. Eyelash darkness (intensity) was measured within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All participants with values available.

Arm/Group Title	Healthy Females
Arm/Group Description	Participant's eyelashes were photographed at one study visit.
Measure Participants	154
Mean (Full Range) [Units on a scale]	122.2 (14.0)

Adverse Events

Adverse Event Reporting Description	Adverse events were not collected.
Arm/Group Title	Healthy Females
Arm/Group Description	Healthy Females
All Cause Mortality
	Healthy Females
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Healthy Females
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Healthy Females
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.