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Completed

NCT Number: NCT02448043

Cutaneous Prostaglandin Application: Nail Growth, Nail Brittleness, and Eye Pressure

Topical prostaglandin agents are used to help reduce eye pressure in glaucoma patients. Bimatoprost (Lumigan 0.01%) is such an agent (Allergan, Inc.). Several of our patients on bimatoprost and an observational study of patients on bimatoprost in another center reported that fingernails grew longer and became less brittle using the topical eye drops to the eyes. The purpose of the double-blinded study is to determine whether the application of the eye drops directly to the proximal nail fold of one hand using the opposite hand as a control will result in longer nails, less brittle nails, and reduced eye pressures should any of the medication be absorbed into the systemic circulation.

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Key information

Conditions

Nail Growth Cessation Intraocular Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

David J. Palmer, MD

Glenview, Illinois, 60026, United States

About this study

In addition to our observations with topical bimatoprost on fingernail growth, Wand and colleagues applied bimatoprost to the base of the fingernails demonstrating a 16.9% increase in fingernail growth from baseline, and a 10.4% increase from baseline on untreated nail beds. Other than these two reports, there are no studies addressing this topic to our knowledge based on a Medline search for off-label use of this drug. Other relevant studies have addressed increased hair and eyelash growth with the prostaglandin agents. Researching the biochemistry of the relationship of prostaglandins to hair and nail growth, the final common pathway appears to be with protein kinase C and the production of tropocollagens. The dermatology literature has demonstrated that both hair and nail keratocytes reside in the nail bed suggesting that increased collagen production may enhance the growth of both the nail bed and nail plate, possibly reducing nail brittleness.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • English speaking
  • Normotensive or glaucoma suspects on no ocular medications
  • No manicure within 2 weeks of the study.

Exclusion criteria

  • Individuals on topical or systemic essential fatty acids (EFA's) in hand lotions, creams, ointments, or medication, or on biotin.
  • Digits with signs of nail injury, deformity, or infection.
  • Nail biters, nail polishers, artificial nail wear or gels, and nail and trimming and filing until the study endpoint.
  • Women of childbearing age who are pregnant or who are trying to become pregnant.
  • Individuals with allergies or sensitivity to prostaglandin agents.

Treatment and study plan

Bimatoprost 0.01%

Drug

Bimatoprost drops added to the proximal nail folds of the randomized study hand digits two times per day for 30 days

Other names: Lumigan 0.01%

Placebo: saline

Other

Placebo drops added to the proximal nail folds of the hand digits opposite the study hand two times per day for 30 days

Primary outcomes

  1. Change From Baseline in Nail Length of Hands

    Time frame: Baseline, 30 days

    Measured by digital calipers (Ironton 6 in. Stainless Steel Digital Fractional Caliper, Northern Tool and Equipment, Burnsville, MN, USA)

  2. Change From Baseline in Nail Length of Digits

    Time frame: Baseline, 30 Days

    Measured by digital calipers (Ironton 6 in. Stainless Steel Digital Fractional Caliper, Northern Tool and Equipment, Burnsville, MN, USA)

  3. Intraocular Pressure at 30 Days of Treatment

    Time frame: Between 7:30 AM and 10:00 AM at 30 days post treatment

    IOP using a Goldmann applanation tonometer (GAT) between 7:30 AM and 10:00 AM

  4. Nail Brittleness at 30 Days of Treatment

    Time frame: Baseline, 30 days

    Scale Title: Nail Brittleness (1-4)

    Subjective assessment by subjects on scale of 1 (no brittleness) to 4 (maximum brittleness).

Secondary outcomes

  1. Number of Days Until the First Nail Chipped

    Time frame: Baseline to 30 days

    Average number of days post-treatment until the first nail chipped

  2. Change in Skin Pigmentation on Hands

    Time frame: Baseline, 30 days

    Photographs taken (knuckle to fingertips over white paper with consistent bulb illumination at the site), with an Apple iPhone 6 (Cupertino, CA, USA) and examined. The investigators reviewed the anonymous photos by number to look for comparative skin pigmentation (increased pigmentation, decreased pigmentation, no change in pigmentation) changes on the hands.

  3. Change in Hirsutism on Hands

    Time frame: Baseline, 30 days

    Photographs taken (knuckle to fingertips over white paper with consistent bulb illumination at the site), with an Apple iPhone 6 (Cupertino, CA, USA) and examined. The investigators reviewed the anonymous photos by number to look for comparative (increased hair growth, decreased hair growth, no change) hair changes on the hands.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Allergan

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 19, 2015
Registry last updated
Dec 13, 2019

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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