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Study of Bimatoprost Gel on Eyelash Growth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01200251
Recruitment Status : Completed
First Posted : September 13, 2010
Last Update Posted : July 16, 2014
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE September 10, 2010
First Posted Date  ICMJE September 13, 2010
Last Update Posted Date July 16, 2014
Study Start Date  ICMJE February 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2010)		 eyelash length [ Time Frame: 6 months ]
eyelash ruler used to measure eyelash length
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2010)
  • eyelash pigment [ Time Frame: 6 mos ]
    blinded grader used digital photos to grade degree of pigment on scale of 1-5
  • eyelash thickness [ Time Frame: 6 mos ]
    blinded grader used digital photos to grade degree of thickness on scale of 1-5
  • eyelash amount [ Time Frame: 6 mos ]
    blinded grader used digital photos to grade degree of amount by counting lashes
  • eyelash side effects [ Time Frame: 6 mos ]
    any side effects (irritation, allergy, iop change, visual acuity, macular edema, uveitis, iris color change, etc... were assessed
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Bimatoprost Gel on Eyelash Growth
Official Title  ICMJE The Role of Bimatoprost Eyelash Gel in Chemotherapy-induced Madarosis: an Analysis of Efficacy and Safety
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Madarosis
  • Hypotrichosis
Intervention  ICMJE 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
Other Name: lumigan
Study Arms  ICMJE
  • Experimental: Bimatoprost treated eyelid
    one eyelid of the patient was randomized to the treatment arm and given the gel to use
    Intervention: Drug: Bimatoprost eyelash gel
  • No Intervention: control arm - no gel
    the other fellow eyelid of the patient did not receive any treatment until month 4 and the patient crossed over to treating both eyelids
Publications * 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. doi: 10.1016/j.jaad.2004.05.002. Erratum In: J Am Acad Dermatol. 2004 Dec;51(6):1040.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2010)		 20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01200251
Other Study ID Numbers  ICMJE 9459
71320 ( Registry Identifier: IND )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Duke University
Original Responsible Party Dr. Carrie Morris, Duke University Medical Center
Current Study Sponsor  ICMJE Duke University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Duke University
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP