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Completed

NCT Number: NCT01200251

Study of Bimatoprost Gel on Eyelash Growth

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.

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Key information

Conditions

Madarosis Hair Diseases Hypotrichosis Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bimatoprost eyelash gel

Drug

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 names: lumigan

Primary outcomes

  1. eyelash length

    Time frame: 6 months

    eyelash ruler used to measure eyelash length

Secondary outcomes

  1. eyelash pigment

    Time frame: 6 mos

    blinded grader used digital photos to grade degree of pigment on scale of 1-5

  2. eyelash thickness

    Time frame: 6 mos

    blinded grader used digital photos to grade degree of thickness on scale of 1-5

  3. eyelash amount

    Time frame: 6 mos

    blinded grader used digital photos to grade degree of amount by counting lashes

  4. 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Sep 13, 2010
Registry last updated
Jul 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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