Topical Cyclosporine Suspension for the Treatment of Brittle Nails
Condition: Brittle Nail Syndrome
MeSH terms: Syndrome
Intervention: topical cyclosporine ophthalmic suspension 0.05%; vehicle
Intervention description: apply 2 drops to 2 target fingernails under occlusion daily; apply 2 drops to 2 target fingernails under occlusion daily for 20 weeks
Intervention MeSH terms: Cyclosporine; Cyclosporins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: brittle nail

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 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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  • 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

        Exclusion Criteria:

          -  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

          -  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