Study of Bimatoprost Gel on Eyelash Growth

Hypotrichosis Clinical Trial

Official title:

The Role of Bimatoprost Eyelash Gel in Chemotherapy-induced Madarosis: an Analysis of Efficacy and Safety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01200251
• Other study ID #: 9459
• Secondary ID: 71320
• Status: Completed
• Phase: Phase 3
• First received: September 10, 2010
• Last updated: July 14, 2014
• Start date: February 2007
• Est. completion date: December 2008

Study information

• Verified date: September 2010
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A internally controlled, single-blinded, randomized controlled trial to investigate the use of Bimatoprost eyelash gel on eyelash growth and appearance in breast cancer patients who suffer from madarosis (loss of eyelashes) due to the side effects of chemotherapy. IND and IRB approval have been obtained.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 18-80 YO females

• madarosis or hypotrichosis (loss of eyelashes) due to chemotherapy used to treat breast cancer

• only breast cancer patients

Exclusion Criteria:

• inability to follow up, apply gel

• active eye/eyelid infection or inflammatory process

• cancer not related to breast cancer, healthy patients

• males

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypotrichosis
• Madarosis

Intervention

Drug:
• Bimatoprost eyelash gel
Bimatoprost 0.03% solution was compounded into a gel - patients used on eyelash margin once daily placing gel with a fingertip or Q-tip for 6 months

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Tosti A, Pazzaglia M, Voudouris S, Tosti G. Hypertrichosis of the eyelashes caused by bimatoprost. J Am Acad Dermatol. 2004 Nov;51(5 Suppl):S149-50. Erratum in: J Am Acad Dermatol. 2004 Dec;51(6):1040. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eyelash length	eyelash ruler used to measure eyelash length	6 months	No
Secondary	eyelash pigment	blinded grader used digital photos to grade degree of pigment on scale of 1-5	6 mos	No
Secondary	eyelash thickness	blinded grader used digital photos to grade degree of thickness on scale of 1-5	6 mos	No
Secondary	eyelash amount	blinded grader used digital photos to grade degree of amount by counting lashes	6 mos	No
Secondary	eyelash side effects	any side effects (irritation, allergy, iop change, visual acuity, macular edema, uveitis, iris color change, etc... were assessed	6 mos	Yes