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

November 26, 2019 updated by: David Palmer, Northwestern University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Glenview, Illinois, United States, 60026
        • David J. Palmer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Right Hand Bimatoprost 0.01% drops, Left Hand Placebo
  • Bimatoprost 0.01% drops placed on the proximal nail folds of the right hand digits two times per day for 30 days.
  • Saline solution drops placed on the proximal nail folds of the left hand digits two times per day for 30 days.
Drug: Bimatoprost 0.01%
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%
Other: Placebo: saline
Placebo drops added to the proximal nail folds of the hand digits opposite the study hand two times per day for 30 days
Other: Left Hand Bimatoprost 0.01% drops, Right Hand Placebo
  • Bimatoprost 0.01% drops placed on the proximal nail folds of the left hand digits two times per day for 30 days.
  • Saline solution drops placed on the proximal nail folds of the right hand digits two times per day for 30 days.
Drug: Bimatoprost 0.01%
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%
Other: Placebo: saline
Placebo drops added to the proximal nail folds of the hand digits opposite the study hand two times per day for 30 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, 30 days
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)
Baseline, 30 Days
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
Between 7:30 AM and 10:00 AM at 30 days post treatment
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).
Baseline, 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline to 30 days
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.
Baseline, 30 days
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.
Baseline, 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Allergan

Investigators

  • Principal Investigator: David J Palmer, MD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2015

Primary Completion (Actual)

May 6, 2016

Study Completion (Actual)

May 6, 2016

Study Registration Dates

First Submitted

May 4, 2015

First Submitted That Met QC Criteria

May 18, 2015

First Posted (Estimate)

May 19, 2015

Study Record Updates

Last Update Posted (Actual)

December 13, 2019

Last Update Submitted That Met QC Criteria

November 26, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00200526

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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