Study of Bimatoprost Solution in Increasing Eyelash Prominence in African Americans With Eyelash Hypotrichosis

NCT00958035 | Completed Phase 4 Results

• 1 other identifier: 192024-039
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily to the upper eyelid margins (where the eyelashes meet the skin) compared with vehicle in increasing overall eyelash prominence in self-identified African American/ethnic black subjects exhibiting hypotrichosis of the eyelashes (inadequate or not enough eyelashes).

Conditions

Hypotrichosis

Outcome Measures

Primary Outcomes (1)

• Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4

  Percentage of treatment responders in overall eyelash prominence, defined as at least a 1-grade improvement from baseline at Month 4 in the Global Eyelash Assessment (GEA) Scale. The GEA is a 4-point scale in which eyelash prominence is assessed from 1 (minimal prominence) to 4 (very marked prominence).

  Month 4

Study Arms (2)

LATISSE®

EXPERIMENTAL

bimatoprost ophthalmic 0.03% solution

Drug: bimatoprost ophthalmic 0.03% solution

Placebo

PLACEBO COMPARATOR

vehicle sterile solution

Drug: vehicle sterile solution (placebo)

Interventions

bimatoprost ophthalmic 0.03% solution DRUG

Apply one drop of study medication along the upper eyelid margin once daily in the evening

Also known as: LATISSE®

LATISSE®

vehicle sterile solution (placebo) DRUG

Apply one drop of study medication along the upper eyelid margin once daily in the evening

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• African American/ethnic black
• Adults at least 18 years of age
• Eyelash prominence assessment of minimal or moderate

You may not qualify if:

• Subjects with uneven lashes or longer on one side than the other
• Any eye disease or abnormality
• Eye surgery
• Severe hyperpigmentation around the eye
• Eyelash implants
• Eyelash extension application
• Any use of eyelash growth products within 6 months
• Any use of prescription eyelash growth products
• Treatments that may affect hair growth
• Requiring eye drop medications for glaucoma

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

MeSH Terms

Conditions

Hypotrichosis

Interventions

Solutions; Bimatoprost

Condition Hierarchy (Ancestors)

Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan, Inc.

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 13, 2009
• Study Start: November 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2010
• Last Updated: January 5, 2012
• Results First Posted: January 5, 2012

Record last verified: 2011-11

Locations

US (1)