Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Allergan | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Right Hand Bimatoprost 0.01% drops, Left Hand Placebo | Other |
|
|
| Left Hand Bimatoprost 0.01% drops, Right Hand Placebo | Other |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days Until the First Nail Chipped | Average number of days post-treatment until the first nail chipped | Baseline to 30 days |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David J Palmer, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David J. Palmer, MD | Glenview | Illinois | 60026 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11176999 | Background | Weston BC. Migraine headache associated with latanoprost. Arch Ophthalmol. 2001 Feb;119(2):300-1. No abstract available. | |
| 2200473 | Background | 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. |
Not provided
Not provided
Not provided
Subjects were recruited voluntarily from private office practices (DP and AS), and a university-based practice (AT).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Right Hand Bimatoprost 0.01% Drops, Left Hand Placebo |
|
| FG001 | Left Hand Bimatoprost 0.01% Drops, Right Hand Placebo |
|
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Right Hand Bimatoprost 0.01% Drops, Left Hand Placebo |
|
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Range from 24-88 years of age |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Intent to treat population | Posted | Mean | Standard Deviation | mm | Baseline, 30 days | Hands | Hands |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bimatoprost 0.01% Drops | Bimatoprost 0.01%: Bimatoprost drops added to the proximal nail folds of the randomized study hand digits two times per day for 30 days |
Not provided
Not provided
Nail chipping reduced the N value at the completion of the study. Suggestion is to etch the nail surface to create a mark, then measure from the nail fold to the nail etch at the end of the trial period.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David J. Palmer | Department of Ophthalmology, Northwestern University Feinberg School of Medicine | 3126958150 | dpalmermd@comcast.net |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
|
| Baseline, 30 days |
| 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 |
| Result | Khouri AS, Fechtner RD, Zimmerman, TJ. Latanoprost: A New Approach to the Treatment of Glaucoma. Today's Therapeutic Trends 14: 225-240, 1997 |
| 11434936 | 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. |
| 19038626 | Result | 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. |
| Result | Sjoquist B. Human pharmacokinetic studies summary. Pharmacia and Upjohn Company Technical Report 9500155. March 25, 1995. |
| 23912967 | 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. |
| 11915838 | Result | 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. |
| 20384750 | Result | 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. |
| 9323945 | Result | 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. |
| Result | Wand M. New side effect of Prostaglandins. Agsocietynet@aaoforums.aao.org. Jan 2015. |
| 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 |
| 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. |
| Left Hand Bimatoprost 0.01% Drops, Right Hand Placebo |
|
| BG002 | Total | Total of all reporting groups |
Number analyzed for each row differs from the Overall analyzed number because the 'All Participants', 'Male', and 'Female' rows identify different populations
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Nail Length of Hands | Mean | Standard Deviation | mm |
|
| Nail Length of Digits | In the "Left Hand Bimatoprost, Right Hand Placebo" group, 1 subject is missing a forefinger | Mean | Standard Deviation | mm |
|
| Intraocular Pressure | No baseline IOP data on 13 subjects | Mean | Standard Deviation | mm Hg |
|
| Nail Brittleness | Scale Title: Nail Brittleness (1-4) Subjective assessment by subjects on scale of 1 (no brittleness) to 4 (maximum brittleness). | No or incomplete data 2 participants | Mean | Standard Deviation | Score on a scale |
|
|
|
|
| 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) | Excluding the negative growth nails and chipped nails combined; one subject is missing a forefinger | Posted | Mean | Standard Deviation | mm | Baseline, 30 Days | Digits | Digits |
|
|
|
|
| Primary | Intraocular Pressure at 30 Days of Treatment | IOP using a Goldmann applanation tonometer (GAT) between 7:30 AM and 10:00 AM | No IOP data on 13 subjects Missing final IOP data on 1 subject Arms are not grouped as 'Bimatoprost 0.01%' and 'Placebo' because this is a split-person study, so every participant received both the treatment and the placebo. Since this outcome is measuring eye pressure, there is no way to distinguish which group/arm is influencing eye pressure. | Posted | Mean | Standard Deviation | mm Hg | Between 7:30 AM and 10:00 AM at 30 days post treatment | Eyes | Eyes |
|
|
|
|
| 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). | No or incomplete data on seven subjects Subjects were asked to assess nail brittleness of both hands and rank them together - i.e. the value each subject gave for nail brittleness was the combination of the placebo hand and the treatment hand. Nail brittleness values were not distinguished between the placebo hands and the treatment hands. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 30 days |
|
|
|
|
| Secondary | Number of Days Until the First Nail Chipped | Average number of days post-treatment until the first nail chipped | - No nail chipping data on 12 participants | Posted | Mean | Standard Deviation | Days | Baseline to 30 days | Hands | Hands |
|
|
|
| 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. |
| Posted | Count of Units | Hands | Baseline, 30 days | Hands | Hands |
|
|
|
| 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. | - No data on 4 participants due to poor photo quality | Posted | Count of Units | Hands | Baseline, 30 days | Hands | Hands |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Placebo | Saline solution drops placed on the proximal nail folds of the hand digits opposite from the study hand two times per day for 30 days. | 0 | 38 | 0 | 38 |
Not provided
Not provided
Not provided
|
| Forefinger |
|
|
| Middle Finger |
|
|
| Ring Finger |
|
|
| Pinky Finger |
|
|
|
| Right eye |
|
|
| Left eye |
|
|
| Increased Pigmentation |
|
| Increased Hair Growth |
|