Clinical trial NCT02448043: Cutaneous Prostaglandin Application: Nail Growth, Nail Brittleness, and Eye Pressure
Official title: Cutaneous Prostaglandin Application: Nail Growth, Nail Brittleness, and Eye Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nail Growth Cessation
Intraocular Pressure
Keywords: brittleness
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2015-05-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Nail Length of Hands
timeFrame: Baseline, 30 days
measure: Change From Baseline in Nail Length of Digits
timeFrame: Baseline, 30 Days
measure: Intraocular Pressure at 30 Days of Treatment
timeFrame: Between 7:30 AM and 10:00 AM at 30 days post treatment
measure: Nail Brittleness at 30 Days of Treatment
timeFrame: Baseline, 30 days
Secondary outcomes:
measure: Number of Days Until the First Nail Chipped
timeFrame: Baseline to 30 days
measure: Change in Skin Pigmentation on Hands
timeFrame: Baseline, 30 days
measure: Change in Hirsutism on Hands
timeFrame: Baseline, 30 days
Other outcomes:
Locations:
city: Glenview
country: United States
facility: David J. Palmer, MD
state: Illinois
Study officials:
affiliation: Northwestern University
name: David J Palmer, MD
role: PRINCIPAL_INVESTIGATOR
References:
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