Safety and Efficacy Study of Bimatoprost to Treat Hypotrichosis of the Eyelashes After Application to the Eyelid Margin - Full Text View

Sponsor:	Allergan
Information provided by (Responsible Party):	Allergan
ClinicalTrials.gov Identifier:	NCT00907426

Purpose

This one-year study evaluates the long-term safety and effectiveness of bimatoprost solution application to the eyelid margin (where the eyelashes meet the skin) to treat hypotrichosis of the eyelashes (inadequate or not enough eyelashes). There will be two different types of subjects participating in the study 1)those with inadequate eyelashes due to natural causes or 2) those with inadequate eyelashes following a complete course of chemotherapy treatment. There will be two treatment periods of six months each. Subjects will receive either the study medication or vehicle in either of the two treatment periods.

Condition	Intervention	Phase
Hypotrichosis	Drug: Treatment period one (0-6 months): Bimatoprost 0.03% sterile solution; Treatment period two (6-12 months): Bimatoprost 0.03% sterile solution Drug: Treatment period one (0-6 months): vehicle sterile solution; Treatment period two (6-12 months): Bimatoprost 0.03% sterile solution Drug: Treatment period one (0-6 months): Bimatoprost 0.03% sterile solution; Treatment period two (6-12 months): vehicle sterile solution	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: androgenetic alopecia

MedlinePlus related topics: Hair Loss

Drug Information available for: Bimatoprost

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Proportion of subjects with an increase in eyelash prominence as well as an increase in subjective feelings about their eyelash appearance [ Time Frame: Change from baseline at month 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in upper eyelash length [ Time Frame: Baseline, Month 4, 6, 10, 12 ] [ Designated as safety issue: No ]
Change in eyelash thickness [ Time Frame: Baseline, Month 4, 6, 10, 12 ] [ Designated as safety issue: No ]
Change in eyelash darkness [ Time Frame: Baseline, Month 4, 6, 10, 12 ] [ Designated as safety issue: No ]

Enrollment:	368
Study Start Date:	August 2009
Study Completion Date:	May 2011
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 0-6 months: Bimatoprost 0.03% sterile solution; 6-12 months: Bimatoprost 0.03% sterile solution	Drug: Treatment period one (0-6 months): Bimatoprost 0.03% sterile solution; Treatment period two (6-12 months): Bimatoprost 0.03% sterile solution For both subject populations: treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% sterile solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% sterile solution using a single-use per eye applicator will be applied to the upper eyelid margin Other Name: LATISSE™
2 0-6 months: vehicle sterile solution; 6-12 months: Bimatoprost 0.03% sterile solution	Drug: Treatment period one (0-6 months): vehicle sterile solution; Treatment period two (6-12 months): Bimatoprost 0.03% sterile solution For both subject populations: treatment period one (0-6 months), once daily, one drop of vehicle sterile solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% sterile solution using a single-use per eye applicator will be applied to the upper eyelid margin Other Name: LATISSE™
3 0-6 months: Bimatoprost 0.03% sterile solution; 6-12 months: vehicle sterile solution	Drug: Treatment period one (0-6 months): Bimatoprost 0.03% sterile solution; Treatment period two (6-12 months): vehicle sterile solution In subjects who have inadequate eyelashes due to natural causes: treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% sterile solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of vehicle sterile solution using a single-use per eye applicator will be applied to the upper eyelid margin Other Name: LATISSE™

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects who have inadequate eyelashes due to natural causes and are not satisfied with their eyelash appearance.
For the post-chemotherapy population: subjects who have inadequate eyelashes following a complete course of chemotherapy treatment and are not satisfied with their eyelash appearance, are considered free of cancer and are well enough to complete the study.

Exclusion Criteria:

Subjects with unequal right and left eyelashes, any eye disease or abnormality, eye surgery, permanent eyeliner, eyelash implants, eyelash extension application.
Any use of over the counter or prescription use eyelash growth products.
Subjects requiring eye drop medications for glaucoma.
Females who are pregnant, nursing or planning a pregnancy during the study or who are of childbearing potential and not using a reliable method of contraception.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00907426

Locations

United States, California

San Diego, California, United States
United Kingdom

London, England, United Kingdom

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

Additional Information:

More Information This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT00907426 History of Changes
Other Study ID Numbers:	192024-038
Study First Received:	May 20, 2009
Last Updated:	November 23, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Allergan:

eyelashes

Additional relevant MeSH terms:

Hypotrichosis
Hair Diseases
Skin Diseases
Bimatoprost
Cloprostenol
Antihypertensive Agents
Cardiovascular Agents

Therapeutic Uses
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012