Brittle Nail SyndromePhase 2NCT01064830
Topical Cyclosporine Suspension for the Treatment of Brittle Nails
A Phase 2 study testing topical cyclosporine ophthalmic suspension 0.05% in people with Brittle Nail Syndrome, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Brittle nail syndrome (BNS) refers to nails that exhibit splitting, raggedness (fraying of the distal edge), and peeling (lamellar onychoschizia).(1) This is a common problem, affecting approximately 20% of women, with higher prevalence among the elderly.(2) A number of factors have been proposed as possible causes of… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Brittle Nail Syndrome
- What is being tested?
- topical cyclosporine ophthalmic suspension 0.05%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Aug 2011
- 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 understand and voluntarily sign an informed consent form
- Must be male or female and aged 18-75 years at time of consent
- Must be able to adhere to the study visit schedule and other protocol requirements
- At least 2 of the following: raggedness (fraying of the distal edge), splitting, and peeling (lamellar onychoschizia) of 2 target fingernails of the same hand. If the subject does not have 2 fingernails affected in the same hand, a second fingernail on the other hand may be used as control.
- A direct microscopic examination with potassium hydroxide (KOH)/calcofluor that is negative for hyphae associated with dermatophytes
- Women of childbearing potential must have a negative pregnancy test at enrollment
Who cannot join
- Inability to provide voluntary consent
- Pregnant or breastfeeding
- Fingernail fungal infection
- Use of any investigational medication within 4 weeks prior to start of study drug
- Subject has any known immunodeficiency or history of malignancy in the last 4 years, excluding nonmelanoma skin cancer.
- Use of any topical nail medication for 2 weeks
Show all 11Show fewer
- Use of any topical nail product (nail polish, hardeners, acetone, etc) for 1 week prior to and during the study.
- Use of biotin 2 weeks before enrollment.
- No genetic nail abnormalities
- Known sensitivity to Restasis® or RDET®.
- Subject has psoriasis, lichen planus, or other abnormalities that could result in a clinically abnormal fingernail
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27516
About this study
Official title: A Single Center, Investigator-blinded Study of the Efficacy of Topical Cyclosporine 0.05% Ophthalmic Suspension (RESTASIS®) Under Occlusion Versus Vehicle in the Treatment of Brittle Nail Syndrome
Brittle nail syndrome (BNS) refers to nails that exhibit splitting, raggedness (fraying of the distal edge), and peeling (lamellar onychoschizia).(1) This is a common problem, affecting approximately 20% of women, with higher prevalence among the elderly.(2) A number of factors have been proposed as possible causes of nail brittleness, such as anemia, biotin deficiency, or cysteine deficiency. (3,4) However, most authors believe that brittle nails are usually caused by dehydration of the nail plate, either from repetitive cycles of hydration and dehydration related to hand washing or from exposure to dehydrating chemicals, such as those found in nail enamel and cuticle removers. (5,6) Inflammation of the nail as a potential contributing factor has never been studied.
There are currently not consistently effective treatments for this condition. Restasis® is effective in treating keratoconjunctivitis sicca. This condition is characterized by the troublesome condition of dry eyes partially due to decreased tear production exacerbated by inflammation. The BNS manifests itself by nail plate dehydration. The two conditions have in common disruption of water balance which gives rise to problematic clinical disorders. The hypothesis is that a product which benefits tear production would also be effective for brittle nails which contain roughly 15% water.
Read the detailed description
Brittle nail syndrome (BNS) is a heterogeneous abnormality, characterized by increased fragility of the nail plate. About 20% of the population is affected by brittle nails and women are affected twice as frequently as men. (2). The diagnostic criteria for brittle nails are not well defined but most authors agree in at least these 3 criteria: onychoschizia (lamellar splitting of the free edge and distal portion of the nail plate), onychorrhexis (longitudinal thickening and thinning or ridging of the nail plate) and fraying or raggedness of the distal edge causing transverse splitting.
Although the cause of nail brittleness is unknown, most authors believe that it is caused by dehydration of the nail plate and that frequent cycles of hydration and dehydration as well as various mechanical and chemical insults increase the incidence of brittle nails. (7) The nail plate contains about 15% water and a very low lipid content so water permeation through the nail plate is high.(8) In fact, it has been demonstrated that the flux of water across the nail plate is 10 times more than the epidermis and 1000 times more permeable than the stratum corneum.(9) A recent report show that there was no significant difference in water content of brittle nails when compared to normal nails and suggested that nail plate water content is random and that nail plates are in a constant state of influx and efflux of water. (10) Keratoconjunctivitis sicca is a chronic, bilateral desiccation of the conjunctiva and cornea due to an inadequate tear film. There are two types: one caused by an inadequate tear volume and the other one caused by an accelerated tear evaporation due to poor tear quality (11). Restasis® (cyclosporine 0.05% topical emulsion) is effective in treating keratoconjunctivitis sicca.
BNS and keratoconjunctivitis sicca have in common a disruption of water balance which gives rise to problematic clinical disorders. We hypothesize that a product which improves corneal dehydration would also be effective for brittle nails. Our rationale for using occlusion is that is has been shown that occluding the skin with a vapor-permeable membrane increases the water flux and the barrier function is recovered at a normal rate. (12) We also hypothesize that using Restasis® (cyclosporine 0.05% topical emulsion) or its vehicle (Refresh Dry Eye Therapy®) under occlusion with a finger cot will increase the nail plate hydration balance and as a consequence will improve nail brittleness. Topical cyclosporine has been shown to be safe in the treatment of other dermatological conditions such as nail psoriasis and oral lichen planus. (13,14) An investigator-blinded design will differentiate if the observed effects are caused by the active ingredient in Restasis® (cyclosporine 0.05% topical emulsion) or its vehicle (Refresh Dry Eye Therapy®).
- Conditions
- Brittle Nail Syndrome
- Being tested
- topical cyclosporine ophthalmic suspension 0.05%, vehicle
- Keywords
- brittle nail
- 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.
topical cyclosporine ophthalmic suspension 0.05%Drug
Also called Restasis
apply 2 drops to 2 target fingernails under occlusion daily
vehicleDrug
Also called Refresh Dry Eye Therapy
apply 2 drops to 2 target fingernails under occlusion daily for 20 weeks
| Study group | Role | What they receive |
|---|---|---|
| topical cyclosporine suspension | Active comparator | apply 2 drops to 2 target nails under occlusion daily for 20 weeks Receives: Drug: topical cyclosporine ophthalmic suspension 0.05% |
| vehicle | Placebo comparator | apply to target nails daily under occlusion daily for 20 weeks Receives: Drug: vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Number of Patients Receiving at Least a 1-grade Improvement in the Physicians Global Improvement Assessment (PGIA) of Two Target Nails.
IN a scale of 0-3 where 0 means normal nail and 3 means severe disease, the number of patients who received at least a decrease of 1 grade in the evaluation of two target nails
Measured: 20 weeks
Secondary outcomes (1)
Patients Assessment of Satisfaction With Length of Fingernails
the percentages of participants who were satisfied with the "length of fingernails"
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionAug 2011
- Study completionAug 2011
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 Nail SyndromeStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Aida Lugo-Somolinos, MD, University of North Carolina, Chapel Hill
- Investigators
- Aida Lugo-Somolinos, MD, Principal investigator, UNC- Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064830
- Sponsor's protocol ID
- 09-1141
- Status last verified
- Feb 2017
- First submitted
- 5 Feb 2010
- Last updated
- 13 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Investigator-blinded Study of the Efficacy of Topical Cyclosporine 0.05% Ophthalmic Suspension (RESTASIS®) Under Occlusion Versus Vehicle in the Treatment of Brittle Nail Syndrome
- ClinicalTrials.gov ID
- NCT01064830
- Acronym / sponsor ID
- 09-1141
- Conditions
- Brittle Nail Syndrome
- Keywords
- brittle nail
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Feb 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 8 Feb 2010 (estimated)
- Results
- Posted 3 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brittle nail syndrome (BNS) refers to nails that exhibit splitting, raggedness (fraying of the distal edge), and peeling (lamellar onychoschizia).(1) This is a common problem, affecting approximately 20% of women, with higher prevalence among the elderly.(2) A number of factors have been proposed as possible causes of nail brittleness, such as anemia, biotin deficiency, or cysteine deficiency. (3,4) However, most authors believe that brittle nails are usually caused by dehydration of the nail plate, either from repetitive cycles of hydration and dehydration related to hand washing or from exposure to dehydrating chemicals, such as those found in nail enamel and cuticle removers. (5,6) Inflammation of the nail as a potential contributing factor has never been studied.
There are currently not consistently effective treatments for this condition. Restasis® is effective in treating keratoconjunctivitis sicca. This condition is characterized by the troublesome condition of dry eyes partially due to decreased tear production exacerbated by inflammation. The BNS manifests itself by nail plate dehydration. The two conditions have in common disruption of water balance which gives rise to problematic clinical disorders. The hypothesis is that a product which benefits tear production would also be effective for brittle nails which contain roughly 15% water.
Detailed description
Brittle nail syndrome (BNS) is a heterogeneous abnormality, characterized by increased fragility of the nail plate. About 20% of the population is affected by brittle nails and women are affected twice as frequently as men. (2). The diagnostic criteria for brittle nails are not well defined but most authors agree in at least these 3 criteria: onychoschizia (lamellar splitting of the free edge and distal portion of the nail plate), onychorrhexis (longitudinal thickening and thinning or ridging of the nail plate) and fraying or raggedness of the distal edge causing transverse splitting.
Although the cause of nail brittleness is unknown, most authors believe that it is caused by dehydration of the nail plate and that frequent cycles of hydration and dehydration as well as various mechanical and chemical insults increase the incidence of brittle nails. (7) The nail plate contains about 15% water and a very low lipid content so water permeation through the nail plate is high.(8) In fact, it has been demonstrated that the flux of water across the nail plate is 10 times more than the epidermis and 1000 times more permeable than the stratum corneum.(9) A recent report show that there was no significant difference in water content of brittle nails when compared to normal nails and suggested that nail plate water content is random and that nail plates are in a constant state of influx and efflux of water. (10) Keratoconjunctivitis sicca is a chronic, bilateral desiccation of the conjunctiva and cornea due to an inadequate tear film. There are two types: one caused by an inadequate tear volume and the other one caused by an accelerated tear evaporation due to poor tear quality (11). Restasis® (cyclosporine 0.05% topical emulsion) is effective in treating keratoconjunctivitis sicca.
BNS and keratoconjunctivitis sicca have in common a disruption of water balance which gives rise to problematic clinical disorders. We hypothesize that a product which improves corneal dehydration would also be effective for brittle nails. Our rationale for using occlusion is that is has been shown that occluding the skin with a vapor-permeable membrane increases the water flux and the barrier function is recovered at a normal rate. (12) We also hypothesize that using Restasis® (cyclosporine 0.05% topical emulsion) or its vehicle (Refresh Dry Eye Therapy®) under occlusion with a finger cot will increase the nail plate hydration balance and as a consequence will improve nail brittleness. Topical cyclosporine has been shown to be safe in the treatment of other dermatological conditions such as nail psoriasis and oral lichen planus. (13,14) An investigator-blinded design will differentiate if the observed effects are caused by the active ingredient in Restasis® (cyclosporine 0.05% topical emulsion) or its vehicle (Refresh Dry Eye Therapy®).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| topical cyclosporine suspension | Active comparator | Drug: topical cyclosporine ophthalmic suspension 0.05%apply 2 drops to 2 target nails under occlusion daily for 20 weeks |
| vehicle | Placebo comparator | Drug: vehicleapply to target nails daily under occlusion daily for 20 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Must understand and voluntarily sign an informed consent form
Key exclusion criteria (11 listed)
- Inability to provide voluntary consent
- Pregnant or breastfeeding
- Fingernail fungal infection
- Use of any investigational medication within 4 weeks prior to start of study drug
- Subject has any known immunodeficiency or history of malignancy in the last 4 years, excluding nonmelanoma skin cancer.
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 |
|---|---|---|
| topical cyclosporine ophthalmic suspension 0.05%Also: Restasisapply 2 drops to 2 target fingernails under occlusion daily | Drug | topical cyclosporine suspension |
| vehicleAlso: Refresh Dry Eye Therapyapply 2 drops to 2 target fingernails under occlusion daily for 20 weeks | Drug | vehicle |
Primary outcome
• Number of Patients Receiving at Least a 1-grade Improvement in the Physicians Global Improvement Assessment (PGIA) of Two Target Nails.
Time frame: 20 weeks
IN a scale of 0-3 where 0 means normal nail and 3 means severe disease, the number of patients who received at least a decrease of 1 grade in the evaluation of two target nails
1 secondary outcome
Patients Assessment of Satisfaction With Length of Fingernails
Time frame: 20 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- 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.
Aida Lugo-Somolinos, MD principal investigator
UNC- Chapel Hill
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 topical cyclosporine ophthalmic suspension 0.05% in people with Brittle Nail Syndrome, run by University of North Carolina, Chapel Hill 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 6 inclusion and 11 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 Mar 2017. 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 3 Dec 2012). 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?
• Number of Patients Receiving at Least a 1-grade Improvement in the Physicians Global Improvement Assessment (PGIA) of Two Target Nails. (time frame: 20 weeks). 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 13 Mar 2017.