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CompletedNCT00986427Updated Aug 20, 2013Results posted

Restasis for Treatment of Brittle Nails

A Phase 2 interventional study of Restasis (cyclosporine ophthalmic emulsion) 0.05% and Refresh® Dry Eye therapy in Brittle Nails, sponsored by Julian M. Mackay-Wiggan. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-08-20.

Sponsored by Julian M. Mackay-Wiggan · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This purpose of this study is to assess the safety and effectiveness of Restasis® ophthalmic emulsion versus emulsion alone( Refresh Dry Eye therapy) both for the treatment of brittle nails and for the enhancement of normal nail growth and texture. The investigators think that daily application of Restasis® to nails and nail beds in patients with brittle nails will enhance nail growth and improve nail texture in both affected and unaffected nails.

Read the detailed description

This is a single center, investigator-blinded (investigator masked), head to head comparison of Restasis® and its vehicle, Refresh® Dry Eye Therapy in 24 patients. Three target fingernails will be identified in each subject. Two of the target nails will be the two nails that have the most severe signs of brittle nail syndrome. The third target nail will be a normal nail or, in the absence of a normal nail, the patient's second-healthiest appearing nail. The patients most normal-appearing nail will be untreated so that growth in the treated nails can be compared to growth in an untreated normal nail, this will be the fourth target nail. Study medication will be applied to target nails (the subjects may also apply to all nails if they wish, except one nail which will be untreated in order to determine the subject's baseline rate of fingernail growth) for 24 weeks. The target nails will be assessed at each visit, every four weeks. There will be a 12-week follow up period after treatment is completed.

This 36 week study will be conducted at one center. Adult male and female patients meeting the inclusion and exclusion criteria will be screened for eligibility. The principal investigator or his/her designee will obtain informed consent from all patients before any protocol specific procedures are performed.

02

Conditions studied

  • Brittle Nails
03

In context

Lead sponsor

Julian M. Mackay-Wiggan is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • must have IRB approved written informed consent prior to participating in any study related procedures
  • Must be a male or female patient 18 to 75 years of age
  • must have a diagnosis of brittle or meet the criteria for a diagnosis of brittle nails at the screening visit based on at least two of the following signs and symptoms of brittle nails in each of the selected nail plates or severe signs (one or more) on each target nail
  • trachyonychia (surface roughness)
  • lamellar onychoschizia (horizontal layering/peeling
  • longitudinal cracking or splitting of the distal edge (raggedness)
  • must have two fingernails with brittle nail signs and symptoms identified at baseline
  • must have two normal or near-normal nails on the same hand
  • female patients of childbearing potential (not surgically sterile or at least 2 years postmenopausal) must have a negative pregnancy at baseline/day 1 and may not be lactating
  • sexually active female subjects who are not surgically sterile or 2 years post menopausal must agree to use contraception/birth control measure while on study (e.g., oral contraceptive, diaphragms with spermicide, condoms with spermicide, intrauterine devices, Norplant System, Depo-Provera, tubal ligation). Monthly urine pregnancy tests will be administered to women of childbearing potential
  • must agree to self administer topical study medication, and must agree to complete all study procedures
  • must be judged to be in good health by medical history and physical examination
  • must be able to adhere to the study visit schedule and other protocol requirements, including avoiding the use of nail polish, adhesive nails, and manicures for the duration of the study

Exclusion criteria

Exclusion Criteria:

  • have a history of surgery of the affected fingernails
  • are chronic nail biters
  • are pregnant, nursing, or planning pregnancy prior to study enrollment
  • have a disturbance of the shape of the affected fingernails (e.g., due to malformation of the underlying bone) that would interfere with the investigator's ability to evaluate photographs or nail changes
  • have onycholysis (lifting of the nail plate off the nail bed) of the affected fingernails
  • have signs of a fungal or bacterial infection of the affected fingernails
  • have a history of psoriasis or lichen planus involving any nail, or active contact dermatitis involving the affected fingernails
  • have used any topical cosmetics or medicated products on the affected nails within 2 weeks of baseline visit
  • have received oral antifungal treatment within 3 months of baseline visit
  • have a known or suspected history of a genetic condition affecting the nails (e.g., Darier's disease, nail-patella syndrome, tuberous sclerosis)
  • have used any investigational drug within the previous 1 month or 5 half-lives of the investigational agent, whichever is longer, or 3 months for any biologic of unknown half-life
  • are known or suspected to have had a substance abuse (drug or alcohol) problem within the previous 3 years
  • is unlikely to comply with the study protocol and prescribed treatment or is unsuitable for any other reason in the opinion of the investigator
  • chronic liver, heart, kidney, or (untreated) thyroid disease
  • have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease
  • currently have any known malignancy or have a history of malignancy other than non-melanoma skin cancer
  • have signs of bacterial, fungal or viral skin lesions that may interfere with evaluation of the target nails
  • known sensitivity to any active or inactive ingredient in Restasis(R) or Refresh(R) Dry Eye Therapy
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
24 participants (actual)

Study arms

  • Active comparator
    1

    Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.

    Drug: Restasis (cyclosporine ophthalmic emulsion) 0.05%

  • Placebo comparator
    2

    Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.

    Drug: Refresh® Dry Eye therapy

Interventions

  • DrugRestasis (cyclosporine ophthalmic emulsion) 0.05%

    cyclosporine ophthalmic emulsion 0.05%

    Also known as: Restasis®

  • DrugRefresh® Dry Eye therapy

    Emulsion contains glycerin 1% and polysorbate 80

    Also known as: Refresh®

06

What researchers measure

Primary outcomes

  1. Change From Baseline in the Physician's Global Assessment (PGA) of Target Fingernails #1 and #2

    Change from baseline in the Physician's Global Assessment (PGA) of target fingernails #1 and #2 as measured at week 24. The PGA is a static evaluation/measure of the severity of brittle nails signs in target fingernails #1 and #2 (the 2 nails with the most severe signs of brittleness). Evaluated sings were the degree of lamellar onychoschizia, ridging, longtitudinal splitting, fragility/breakage and thickness. The PGA was scored on a 6 point scale from 0 to 5, in which 0 = none, 1 = mild, 2 = mild to moderate, 3 = moderate, 4 = moderate to severe, 5 = severe. A negative number change from baseline (decrease in grade score) indicates improvement and a positive change (increase in grade score) indicates worsening.

    Time frame: Baseline, week 24

Secondary outcomes

  1. Change From Baseline in Quality of Life (QOL) Related to Nail Disease

    Change from baseline in quality of life as measured at week 24 by the subject satisfaction Questionnaire question: "Overall, how satisfied are you with your nails?" Responses ranged from 1 (very satisfied) to 5 (very unsatisfied). A negative number changed from baseline (decrease in grade score) indicates improvement and a positive change (increase in grade score) indicates worsening.

    Time frame: Baseline, week 24

  2. Growth of the Treated and Untreated Nail in the Previous 4 Weeks

    Growth of the treated and untreated nail the previous 4 weeks. Nail growth was measured in millimeters.

    Time frame: Week 24

  3. Number of Subjects Achieving Improvement in the Physician's Global Improvement Assessment (PGIA)

    Number of subjects achieving improvement in the PGIA. The investigator assessed the two target fingernails with a rating of Excellent, Good, Fair, No Improvement or Worse based on the comparison between the nails at the current visit and high-resolution photographs of the nails taken at baseline. An improvement was a score of Excellent/Good/Fair vs. No Improvement/Worse.

    Time frame: Week 24

07

Results

Posted Aug 20, 2013
Limitations and caveats
Small Sample Size

Participant flow

24 patients recruited.

Participant flow — Overall Study
MilestoneRestasis® ArmRefresh® Arm
Started1212
Completed812
Not completed40
Withdrew: Lost to follow-up20
Withdrew: Lack of efficacy10
Withdrew: Withdrawal by subject10

Outcome measures

PrimaryChange From Baseline in the Physician's Global Assessment (PGA) of Target Fingernails #1 and #2

Change from baseline in the Physician's Global Assessment (PGA) of target fingernails #1 and #2 as measured at week 24. The PGA is a static evaluation/measure of the severity of brittle nails signs in target fingernails #1 and #2 (the 2 nails with the most severe signs of brittleness). Evaluated sings were the degree of lamellar onychoschizia, ridging, longtitudinal splitting, fragility/breakage and thickness. The PGA was scored on a 6 point scale from 0 to 5, in which 0 = none, 1 = mild, 2 = mild to moderate, 3 = moderate, 4 = moderate to severe, 5 = severe. A negative number change from baseline (decrease in grade score) indicates improvement and a positive change (increase in grade score) indicates worsening.

Time frame:
Baseline, week 24
Reported as:
Mean · scores on a scale
Change From Baseline in the Physician's Global Assessment (PGA) of Target Fingernails #1 and #2
scores on a scaleRestasis® ArmRefresh® Arm
Change From Baseline in the Physician's Global Assessment (PGA) of Target Fingernails #1 and #2-1.4 ± 0.90-1.4 ± 0.67
SecondaryChange From Baseline in Quality of Life (QOL) Related to Nail Disease

Change from baseline in quality of life as measured at week 24 by the subject satisfaction Questionnaire question: "Overall, how satisfied are you with your nails?" Responses ranged from 1 (very satisfied) to 5 (very unsatisfied). A negative number changed from baseline (decrease in grade score) indicates improvement and a positive change (increase in grade score) indicates worsening.

Time frame:
Baseline, week 24
Reported as:
Mean · scores on a scale
Change From Baseline in Quality of Life (QOL) Related to Nail Disease
scores on a scaleRestasis® ArmRefresh® Arm
Change From Baseline in Quality of Life (QOL) Related to Nail Disease-1.6 ± 1.19-0.9 ± 1.97
SecondaryGrowth of the Treated and Untreated Nail in the Previous 4 Weeks

Growth of the treated and untreated nail the previous 4 weeks. Nail growth was measured in millimeters.

Time frame:
Week 24
Reported as:
Mean · Millimeters (mm)
Growth of the Treated and Untreated Nail in the Previous 4 Weeks
Millimeters (mm)Restasis® Arm Treated NailRestasis® Arm Untreated NailRefresh® Dry Eye Treated NailRefresh® Dry Eye Untreated Nail
Growth of the Treated and Untreated Nail in the Previous 4 Weeks3.1 ± 1.362.9 ± 1.832.9 ± 1.152.7 ± 0.62
SecondaryNumber of Subjects Achieving Improvement in the Physician's Global Improvement Assessment (PGIA)

Number of subjects achieving improvement in the PGIA. The investigator assessed the two target fingernails with a rating of Excellent, Good, Fair, No Improvement or Worse based on the comparison between the nails at the current visit and high-resolution photographs of the nails taken at baseline. An improvement was a score of Excellent/Good/Fair vs. No Improvement/Worse.

Time frame:
Week 24
Reported as:
Number · participants
Number of Subjects Achieving Improvement in the Physician's Global Improvement Assessment (PGIA)
participantsRestasis® ArmRefresh® Arm
Number of Subjects Achieving Improvement in the Physician's Global Improvement Assessment (PGIA)109

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Restasis® Arm—1/12 (8.3%)9/12 (75%)
Refresh® Arm—0/12 (0%)8/12 (66.7%)
Most frequent serious events
Most frequent serious events
EventRestasis® ArmRefresh® Arm
HematemasisGastrointestinal disorders1/120/12
Most frequent other events
Showing 10 of 22
Most frequent other events
EventRestasis® ArmRefresh® Arm
Upper respiratory infectionInfections and infestations4/126/12
Stomach virusInfections and infestations0/122/12
AnemiaBlood and lymphatic system disorders1/120/12
Dry eye symptomEye disorders0/121/12
ConstipationGastrointestinal disorders1/120/12
NauseaGastrointestinal disorders1/120/12
FatigueGeneral disorders0/121/12
Flu signs and symptomsGeneral disorders1/120/12
HematemasisGastrointestinal disorders1/120/12
Inflammation of right shoulder (from a fall)General disorders1/120/12

Baseline characteristics

Age Continuous
Age Continuous(years)Restasis® ArmRefresh® ArmTotal
Mean59.8 ± 49.4059.6 ± 12.6959.7 ± 13.28
Sex: Female, Male
Sex: Female, Male(Participants)Restasis® ArmRefresh® ArmTotal
Female101121
Male213
08

Study locations

1 site
  • Columbia University Medical Center Department of Dermatology
    New York, New York 10032, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00986427
Lead sponsor
Julian M. Mackay-Wiggan
Collaborators
Allergan
Responsible party
Julian M. Mackay-Wiggan (Assistant Clinical Professor of Dermatology, Columbia University) — Sponsor-investigator
First posted
Sep 30, 2009
Start date
Jul 2009
Primary completion
Jul 2010
Completion
Dec 2012
Results posted
Aug 20, 2013
Last update
Aug 20, 2013

Study contacts

Julian Mackay Wiggan, MD, MS
principal investigator · Columbia University Medical Center Department of Dermatolgoy

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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