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

Intraocular Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02448043
• Other study ID #: STU00200526
• Status: Completed
• Phase: N/A
• Start date: June 4, 2015
• Est. completion date: May 6, 2016

Study information

• Verified date: November 2019
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 6, 2016
• Est. primary completion date: May 6, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intraocular Pressure
• Nail Growth Cessation

Intervention

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:
• 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

Locations

Country	Name	City	State
United States	David J. Palmer, MD	Glenview	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Allergan

Country where clinical trial is conducted

United States, 

References & Publications (13)

Bean GW, Camras CB. Commercially available prostaglandin analogs for the reduction of intraocular pressure: similarities and differences. Surv Ophthalmol. 2008 Nov;53 Suppl1:S69-84. doi: 10.1016/j.survophthal.2008.08.012. Review. — View Citation

Cohen JL. Enhancing the growth of natural eyelashes: the mechanism of bimatoprost-induced eyelash growth. Dermatol Surg. 2010 Sep;36(9):1361-71. doi: 10.1111/j.1524-4725.2010.01522.x. Review. — View Citation

Janis J (ed). Nail bed injuries. Essential of Plastic Surgery: A UT Southwestern Medical Center Handbook. St Louis, MO: Quality Medical Publishing, Inc: 560-567, 2007.

Johnstone MA. Hypertrichosis and increased pigmentation of eyelashes and adjacent hair in the region of the ipsilateral eyelids of patients treated with unilateral topical latanoprost. Am J Ophthalmol. 1997 Oct;124(4):544-7. — View Citation

Khouri AS, Fechtner RD, Zimmerman, TJ. Latanoprost: A New Approach to the Treatment of Glaucoma. Today's Therapeutic Trends 14: 225-240, 1997

Seed Oils and Essential Fatty Acids. Retrieved 5/21/12 http://www.naturopathica.com/system/user_files/attachments/7/original/Naturopathica_Seed_Oils.pdf

Sjoquist B. Human pharmacokinetic studies summary. Pharmacia and Upjohn Company Technical Report 9500155. March 25, 1995.

Tan J, Berke S. Latanoprost-induced prostaglandin-associated periorbitopathy. Optom Vis Sci. 2013 Sep;90(9):e245-7; discussion 1029. doi: 10.1097/OPX.0b013e31829d8dd7. — View Citation

Wand M, Shields BM. Cystoid macular edema in the era of ocular hypotensive lipids. Am J Ophthalmol. 2002 Mar;133(3):393-7. Review. — View Citation

Wand M. New side effect of Prostaglandins. Agsocietynet@aaoforums.aao.org. Jan 2015.

Weston BC. Migraine headache associated with latanoprost. Arch Ophthalmol. 2001 Feb;119(2):300-1. — View Citation

Woodward DF, Krauss AH, Chen J, Lai RK, Spada CS, Burk RM, Andrews SW, Shi L, Liang Y, Kedzie KM, Chen R, Gil DW, Kharlamb A, Archeampong A, Ling J, Madhu C, Ni J, Rix P, Usansky J, Usansky H, Weber A, Welty D, Yang W, Tang-Liu DD, Garst ME, Brar B, Wheel — View Citation

Ziboh VA, Miller CC. Essential fatty acids and polyunsaturated fatty acids: significance in cutaneous biology. Annu Rev Nutr. 1990;10:433-50. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Nail Length of Hands	Measured by digital calipers (Ironton 6 in. Stainless Steel Digital Fractional Caliper, Northern Tool and Equipment, Burnsville, MN, USA)	Baseline, 30 days
Primary	Change From Baseline in Nail Length of Digits	Measured by digital calipers (Ironton 6 in. Stainless Steel Digital Fractional Caliper, Northern Tool and Equipment, Burnsville, MN, USA)	Baseline, 30 Days
Primary	Intraocular Pressure at 30 Days of 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
Primary	Nail Brittleness at 30 Days of Treatment	Scale Title: Nail Brittleness (1-4); Subjective assessment by subjects on scale of 1 (no brittleness) to 4 (maximum brittleness).	Baseline, 30 days
Secondary	Number of Days Until the First Nail Chipped	Average number of days post-treatment until the first nail chipped	Baseline to 30 days
Secondary	Change in Skin Pigmentation on Hands	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
Secondary	Change in Hirsutism on Hands	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