Brittle NailsPhase 2NCT00986427
Restasis for Treatment of Brittle Nails
A Phase 2 study testing Restasis (cyclosporine ophthalmic emulsion) 0.05% and Refresh® Dry Eye therapy in people with Brittle Nails, run by Julian M. Mackay-Wiggan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Brittle Nails
- What is being tested?
- Restasis (cyclosporine ophthalmic emulsion) 0.05% and Refresh® Dry Eye therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Dec 2012
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center Department of Dermatology
New York, New York, 10032
About this study
Official title: Restasis® Ophthalmic Emulsion for the Treatment of Brittle Nails
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.
- Conditions
- Brittle Nails
- Being tested
- Restasis (cyclosporine ophthalmic emulsion) 0.05%, Refresh® Dry Eye therapy
- Medical subject headings
- Twenty-Nail Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restasis (cyclosporine ophthalmic emulsion) 0.05%Drug
Also called Restasis®
cyclosporine ophthalmic emulsion 0.05%
Refresh® Dry Eye therapyDrug
Also called Refresh®
Emulsion contains glycerin 1% and polysorbate 80
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period. Receives: Drug: Restasis (cyclosporine ophthalmic emulsion) 0.05% |
| 2 | Placebo comparator | 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. Receives: Drug: Refresh® Dry Eye therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, week 24
Secondary outcomes (3)
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.
Measured: Baseline, week 24
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.
Measured: Week 24
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.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2010
- Study completionDec 2012
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.
- Other trials for Brittle NailsStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julian M. Mackay-Wiggan
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor-investigator, Julian M. Mackay-Wiggan, Columbia University
- Investigators
- Julian Mackay Wiggan, MD, MS, Principal investigator, Columbia University Medical Center Department of Dermatolgoy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986427
- Sponsor's protocol ID
- AAAD9927
- Other IDs
- Res-01-2009
- Status last verified
- Jul 2013
- First submitted
- 29 Sep 2009
- Last updated
- 20 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restasis® Ophthalmic Emulsion for the Treatment of Brittle Nails
- ClinicalTrials.gov ID
- NCT00986427
- Acronym / sponsor ID
- AAAD9927
- Conditions
- Brittle Nails
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Julian M. Mackay-WigganUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Jul 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Sep 2009 (estimated)
- Results
- Posted 20 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Restasis (cyclosporine ophthalmic emulsion) 0.05%Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period. |
| 2 | Placebo comparator | Drug: Refresh® Dry Eye therapySubjects 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (18 listed)
- 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
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 |
|---|---|---|
| Restasis (cyclosporine ophthalmic emulsion) 0.05%Also: Restasis®cyclosporine ophthalmic emulsion 0.05% | Drug | 1 |
| Refresh® Dry Eye therapyAlso: Refresh®Emulsion contains glycerin 1% and polysorbate 80 | Drug | 2 |
Primary outcome
Change From Baseline in the Physician's Global Assessment (PGA) of Target Fingernails #1 and #2
Time frame: Baseline, week 24
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.
3 secondary outcomes
Change From Baseline in Quality of Life (QOL) Related to Nail Disease
Time frame: Baseline, week 24
Growth of the Treated and Untreated Nail in the Previous 4 Weeks
Time frame: Week 24
Number of Subjects Achieving Improvement in the Physician's Global Improvement Assessment (PGIA)
Time frame: Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Julian Mackay Wiggan, MD, MS principal investigator
Columbia University Medical Center Department of Dermatolgoy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Restasis (cyclosporine ophthalmic emulsion) 0.05% and Refresh® Dry Eye therapy in people with Brittle Nails, run by Julian M. Mackay-Wiggan 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 13 inclusion and 18 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 20 Aug 2013. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2013). 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 the Physician's Global Assessment (PGA) of Target Fingernails #1 and #2 (time frame: Baseline, week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2013.