Topical Cyclosporine Suspension for the Treatment of Brittle Nails
| Status: | Archived |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | February 2010 |
| End Date: | February 2011 |
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.
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®).
We found this trial at
1
site
101 Manning Dr
Chapel Hill, North Carolina 27599
Chapel Hill, North Carolina 27599
(919) 966-4131
University of North Carolina Hospital at Chapel Hill The UNC Health Care System is a...
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