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

NCT ID: NCT02448043

Last Updated: 2019-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-04

Study Completion Date

2016-05-06

Brief Summary

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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

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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.

Conditions

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Nail Growth Cessation Intraocular Pressure

Keywords

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brittleness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type OTHER

Bimatoprost 0.01%

Intervention Type DRUG

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

Placebo: saline

Intervention Type OTHER

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

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.

Group Type OTHER

Bimatoprost 0.01%

Intervention Type DRUG

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

Placebo: saline

Intervention Type OTHER

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

Interventions

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Bimatoprost 0.01%

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

Intervention Type DRUG

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

Intervention Type OTHER

Other Intervention Names

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Lumigan 0.01%

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Allergan

INDUSTRY

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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David Palmer

Assistant Professor of Clinical Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David J Palmer, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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David J. Palmer, MD

Glenview, Illinois, United States

Site Status

Countries

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United States

References

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Weston BC. Migraine headache associated with latanoprost. Arch Ophthalmol. 2001 Feb;119(2):300-1. No abstract available.

Reference Type BACKGROUND
PMID: 11176999 (View on PubMed)

Ziboh VA, Miller CC. Essential fatty acids and polyunsaturated fatty acids: significance in cutaneous biology. Annu Rev Nutr. 1990;10:433-50. doi: 10.1146/annurev.nu.10.070190.002245. No abstract available.

Reference Type BACKGROUND
PMID: 2200473 (View on PubMed)

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

Reference Type RESULT

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, Wheeler LA, Kaplan LJ. The pharmacology of bimatoprost (Lumigan). Surv Ophthalmol. 2001 May;45 Suppl 4:S337-45. doi: 10.1016/s0039-6257(01)00224-7.

Reference Type RESULT
PMID: 11434936 (View on PubMed)

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.

Reference Type RESULT
PMID: 19038626 (View on PubMed)

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

Reference Type RESULT

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.

Reference Type RESULT
PMID: 23912967 (View on PubMed)

Wand M, Shields BM. Cystoid macular edema in the era of ocular hypotensive lipids. Am J Ophthalmol. 2002 Mar;133(3):393-7. doi: 10.1016/s0002-9394(01)01412-x.

Reference Type RESULT
PMID: 11915838 (View on PubMed)

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.

Reference Type RESULT
PMID: 20384750 (View on PubMed)

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. doi: 10.1016/s0002-9394(14)70870-0.

Reference Type RESULT
PMID: 9323945 (View on PubMed)

Wand M. New side effect of Prostaglandins. [email protected]. Jan 2015.

Reference Type RESULT

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

Reference Type RESULT

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.

Reference Type RESULT

Other Identifiers

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STU00200526

Identifier Type: -

Identifier Source: org_study_id