Safety and Efficacy Study of Bimatoprost to Treat Hypotrichosis of the Eyelashes After Application to the Eyelid Margin

NCT00907426 | Completed Phase 3 Results

• 1 other identifier: 192024-038
• Study Type: interventional
• Target: 368
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Hypotrichosis

Keywords

eyelashes

Outcome Measures

Primary Outcomes (1)

• Percentage of Treatment Responders at Month 4

  Percentage of Treatment Responders at Month 4 defined by: a) at least a 1-grade improvement from baseline in the Global Eyelash Assessment (GEA) score, AND b) at least a 3-point improvement from baseline in the total score for Domain 2 of the Eyelash Symptom Questionnaire (ESQ). The GEA 4-point scale assessed eyelash prominence from 1 (minimal) to 4 (very marked). Domain 2 of the ESQ assessed subjective attributes of confidence, attractiveness, and professionalism rated on a 5-point scale from 1 (very much disagree) to 5 (very much agree) for a total score between 3 and 15.

  Month 4

Secondary Outcomes (3)

• Change From Baseline in Upper Eyelash Length at Month 4

  Baseline, Month 4

• Change From Baseline in Average Progressive Upper Eyelash Thickness at Month 4

  Baseline, Month 4

• Change From Baseline in Upper Eyelash Darkness at Month 4

  Baseline, Month 4

Other Outcomes (1)

• Percentage of Subjects With at Least a 1-Grade Improvement in Global Eyelash Assessment (GEA) Score at Month 4

  Month 4

Study Arms (3)

Bimatoprost 0.03% Followed by Bimatoprost 0.03%

EXPERIMENTAL

Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% 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% solution using a single-use per eye applicator will be applied to the upper eyelid margin.

Drug: Bimatoprost 0.03% solution

Bimatoprost 0.03% Followed by Vehicle

OTHER

Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% 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 solution using a single-use per eye applicator will be applied to the upper eyelid margin.

Drug: Bimatoprost 0.03% solution; Drug: Vehicle solution

Vehicle Followed by Bimatoprost 0.03%

OTHER

Treatment period one (0-6 months), once daily, one drop of vehicle 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% solution using a single-use per eye applicator will be applied to the upper eyelid margin.

Drug: Bimatoprost 0.03% solution; Drug: Vehicle solution

Interventions

Bimatoprost 0.03% solution DRUG

Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).

Also known as: LATISSE™

Bimatoprost 0.03% Followed by Bimatoprost 0.03%; Bimatoprost 0.03% Followed by Vehicle; Vehicle Followed by Bimatoprost 0.03%

Vehicle solution DRUG

Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).

Also known as: LATISSE™

Bimatoprost 0.03% Followed by Vehicle; Vehicle Followed by Bimatoprost 0.03%

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allergan: lead

Study Sites (2)

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

London, England, United Kingdom

Location

Related Publications (2)

• Wirta D, Baumann L, Bruce S, Ahluwalia G, Weng E, Daniels S. Safety and Efficacy of Bimatoprost for Eyelash Growth in Postchemotherapy Subjects. J Clin Aesthet Dermatol. 2015 Apr;8(4):11-20.

  PMID: 26060513 DERIVED

• Harii K, Arase S, Tsuboi R, Weng E, Daniels S, VanDenburgh A. Bimatoprost for eyelash growth in Japanese subjects: two multicenter controlled studies. Aesthetic Plast Surg. 2014 Apr;38(2):451-60. doi: 10.1007/s00266-014-0293-7. Epub 2014 Mar 19.

  PMID: 24643895 DERIVED

MeSH Terms

Conditions

Hypotrichosis

Interventions

Bimatoprost; Solutions

Condition Hierarchy (Ancestors)

Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

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 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2009
• First Posted: May 22, 2009
• Study Start: August 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: May 1, 2011
• Last Updated: September 19, 2012
• Results First Posted: September 19, 2012

Record last verified: 2012-08

Locations

US (1); GB (1)