Nail Growth CessationNCT02448043

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

A study testing Bimatoprost 0.01% in people with Nail Growth Cessation and Intraocular Pressure, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Nail Growth Cessation, Intraocular Pressure
What is being tested?: Bimatoprost 0.01%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 45 participants
Where: 1 siteUnited States
Study dates: 4 Jun 2015to 6 May 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

English speaking
Normotensive or glaucoma suspects on no ocular medications
No manicure within 2 weeks of the study.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

David J. Palmer, MD
Glenview, Illinois, 60026

Other trials in United States

About this study

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.

Read the 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.

Conditions: Nail Growth Cessation, Intraocular Pressure
Being tested: Bimatoprost 0.01%, Placebo: saline
Keywords: brittleness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bimatoprost 0.01%Drug
Also called Lumigan 0.01%
Bimatoprost drops added to the proximal nail folds of the randomized study hand digits two times per day for 30 days
Placebo: salineOther
Placebo drops added to the proximal nail folds of the hand digits opposite the study hand two times per day for 30 days

Study groups in NCT02448043
Study group	Role	What they receive
Right Hand Bimatoprost 0.01% drops, Left Hand Placebo	Other	* 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. Receives: Drug: Bimatoprost 0.01%; Other: Placebo: saline
Left Hand Bimatoprost 0.01% drops, Right Hand Placebo	Other	* 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. Receives: Drug: Bimatoprost 0.01%; Other: Placebo: saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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)
Measured: 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
Measured: 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).
Measured: Baseline, 30 days

Secondary outcomes (3)

Number of Days Until the First Nail Chipped
Average number of days post-treatment until the first nail chipped
Measured: 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.
Measured: 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.
Measured: Baseline, 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jun 20156 May 2016

First posted19 May 2015 (estimated)
Study start4 Jun 2015
Primary completion6 May 2016
Study completion6 May 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Nail Growth CessationStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02448043
Sponsor's protocol ID: STU00200526
Status last verified: Nov 2019
First submitted: 4 May 2015
Last updated: 13 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Weston BC. Migraine headache associated with latanoprost. Arch Ophthalmol. 2001 Feb;119(2):300-1. No abstract available.
PubMed 11176999
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.
PubMed 2200473
Khouri AS, Fechtner RD, Zimmerman, TJ. Latanoprost: A New Approach to the Treatment of Glaucoma. Today's Therapeutic Trends 14: 225-240, 1997
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.
PubMed 11434936
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.
PubMed 19038626
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.
PubMed 23912967
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.
PubMed 11915838
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.
PubMed 20384750
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.
PubMed 9323945
Wand M. New side effect of Prostaglandins. Agsocietynet@aaoforums.aao.org. Jan 2015.
Seed Oils and Essential Fatty Acids. Retrieved 5/21/12 http://www.naturopathica.com/system/user_files/attachments/7/original/Naturopathica_Seed_Oils.pdf
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.

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cutaneous Prostaglandin Application: Nail Growth, Nail Brittleness, and Eye Pressure
ClinicalTrials.gov ID: NCT02448043
Acronym / sponsor ID: STU00200526
Conditions: Nail Growth Cessation, Intraocular Pressure
Keywords: brittleness
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Collaborators: Allergan
Study start: 4 Jun 2015 (actual)
Primary completion: 6 May 2016 (actual)
Study completion: 6 May 2016 (actual)
First posted: 19 May 2015 (estimated)
Results: Posted 13 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Right Hand Bimatoprost 0.01% drops, Left Hand Placebo	Other	Drug: Bimatoprost 0.01%, Other: Placebo: saline* 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.
Left Hand Bimatoprost 0.01% drops, Right Hand Placebo	Other	Drug: Bimatoprost 0.01%, Other: Placebo: saline* 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

English speaking
Normotensive or glaucoma suspects on no ocular medications
No manicure within 2 weeks of the study.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bimatoprost 0.01%Also: Lumigan 0.01%Bimatoprost drops added to the proximal nail folds of the randomized study hand digits two times per day for 30 days	Drug	Left Hand Bimatoprost 0.01% drops, Right Hand Placebo, Right Hand Bimatoprost 0.01% drops, Left Hand Placebo
Placebo: salinePlacebo 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, Right Hand Bimatoprost 0.01% drops, Left Hand Placebo

Primary outcome

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)
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)
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
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).

3 secondary outcomes

Number of Days Until the First Nail Chipped
Time frame: Baseline to 30 days
Change in Skin Pigmentation on Hands
Time frame: Baseline, 30 days
Change in Hirsutism on Hands
Time frame: Baseline, 30 days

Results and safety

Results posted to the registry on 13 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Right Hand Bimatoprost 0.01% Drops, Left Hand Placebo	23	20
Left Hand Bimatoprost 0.01% Drops, Right Hand Placebo	22	18

Primary outcome: Change From Baseline in Nail Length of Hands

Time frame: Baseline, 30 days. Mean (Standard Deviation). Unit: mm

Measure	Bimatoprost 0.01% Drops n = 38	Placebo n = 38
Total Nail Growth (power = 1.0)	13.49 (1.14)	15.10 (1.29)
Individual Nail Growth	1.34 (0.33)	1.51 (0.48)

Bimatoprost 0.01% Drops vs Placebo: p = 0.532, t-test, 2 sided

Population analysed: Intent to treat population

Primary outcome: Change From Baseline in Nail Length of Digits

Time frame: Baseline, 30 Days. Mean (Standard Deviation). Unit: mm

Measure	Bimatoprost 0.01% Drops n = 38	Placebo n = 38
Thumb	1.58 (1.70)	1.48 (1.82)
Forefinger	1.26 (1.38)	1.02 (2.76)
Middle Finger	0.90 (1.76)	1.40 (1.50)
Ring Finger	1.33 (1.27)	1.76 (1.77)
Pinky Finger	1.63 (1.55)	1.62 (1.65)

Bimatoprost 0.01% Drops vs Placebo: p = 0.523, t-test, 2 sided

Population analysed: Excluding the negative growth nails and chipped nails combined; one subject is missing a forefinger

Primary outcome: Intraocular Pressure at 30 Days of Treatment

Time frame: Between 7:30 AM and 10:00 AM at 30 days post treatment. Mean (Standard Deviation). Unit: mm Hg

Measure	Right Hand Bimatoprost 0.01% Drops, Left Hand Placebo n = 13	Left Hand Bimatoprost 0.01% Drops, Right Hand Placebo n = 11
Both eyes	16.42 (3.24)	13.91 (1.80)
Right eye	16.38 (3.73)	14.0 (2.10)
Left eye	16.46 (2.82)	13.82 (1.54)

Right Hand Bimatoprost 0.01% Drops, Left Hand Placebo vs Left Hand Bimatoprost 0.01% Drops, Right Hand Placebo: p = 0.912, t-test, 2 sided

Population analysed: 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.

Primary outcome: Nail Brittleness at 30 Days of Treatment

Time frame: Baseline, 30 days. Mean (Standard Deviation). Unit: Score on a scale

Measure	Right Hand Bimatoprost 0.01% Drops, Left Hand Placebo n = 16	Left Hand Bimatoprost 0.01% Drops, Right Hand Placebo n = 15
Value	2.25 (0.93)	2.43 (1.10)

Right Hand Bimatoprost 0.01% Drops, Left Hand Placebo vs Left Hand Bimatoprost 0.01% Drops, Right Hand Placebo: p = 0.062, t-test, 2 sided

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bimatoprost 0.01% Drops	0 of 38 (0%)	0 of 38 (0%)	Not reported
Placebo	0 of 38 (0%)	0 of 38 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 11176999Weston BC. Migraine headache associated with latanoprost. Arch Ophthalmol. 2001 Feb;119(2):300-1. No abstract available.
Background: PubMed 2200473Ziboh 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.
Results publicationKhouri AS, Fechtner RD, Zimmerman, TJ. Latanoprost: A New Approach to the Treatment of Glaucoma. Today's Therapeutic Trends 14: 225-240, 1997
Results publication: PubMed 11434936Woodward 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.
Results publication: PubMed 19038626Bean 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.
Results publicationSjoquist B. Human pharmacokinetic studies summary. Pharmacia and Upjohn Company Technical Report 9500155. March 25, 1995.
Results publication: PubMed 23912967Tan J, Berke S. Latanoprost-induced prostaglandin-associated periorbitopathy. Optom Vis Sci. 2013 Sep;90(9):e245-7; discussion 1029. doi: 10.1097/OPX.0b013e31829d8dd7.
Results publication: PubMed 11915838Wand 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.
Results publication: PubMed 20384750Cohen 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.
Results publication: PubMed 9323945Johnstone 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.
Results publicationWand M. New side effect of Prostaglandins. Agsocietynet@aaoforums.aao.org. Jan 2015.
Results publicationSeed Oils and Essential Fatty Acids. Retrieved 5/21/12 http://www.naturopathica.com/system/user_files/attachments/7/original/Naturopathica_Seed_Oils.pdf

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David J Palmer, MD principal investigator

Northwestern University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Bimatoprost 0.01% in people with Nail Growth Cessation and Intraocular Pressure, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Nail Length of Hands (time frame: Baseline, 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02448043, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.