Restasis for Treatment of Brittle Nails

2014-08-27 03:18:59 | BioPortfolio


This purpose of this study is to assess the safety and effectiveness of Restasis (R) 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 (R) to nails and nail beds in patients with brittle nails will enhance nail growth and improve nail texture in both affected and unaffected nails.


This is a single center, investigator-blinded (investigator masked), head to head comparison of Restasis(R) and its vehicle, Refresh(R) 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Brittle Nails


Restasis (cyclosporine ophthalmic emulsion) 0.05%, Refresh(R) Dry Eye therapy


Columbia University Medical Center Department of Dermatology
New York
New York
United States


Active, not recruiting


Columbia University

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:18:59-0400

Clinical Trials [657 Associated Clinical Trials listed on BioPortfolio]

Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients

This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion administered twice daily following LASIK surgery

Topical Cyclosporine Suspension for the Treatment of Brittle Nails

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 ap...

Physician's Evaluation of Cyclosporine Ophthalmic Emulsion 0.05%

The objective of this retrospective chart review is to evaluate the patient characteristics, treatment variations and efficacy of a second trial of Cyclosporine Ophthalmic Emulsion 0.05% t...

Safety and Efficacy of Cyclosporine Ophthalmic Emulsion in Patients With Primary Pterygium

This study will evaluate the safety and efficacy of Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) in patients with primary pterygium (abnormal growth on surface of eye).

Efficacy of 0.05 % Cyclosporine Ophthalmic Emulsion Compare With Tear in Meibomian Gland Dysfunction

To evaluate the efficacy of 0.05% cyclosporine ophthalmic emulsion (Restasis® , Allergan) versus an artificial tears alone in patients with meibomian gland dysfunction that have abnormal ...

PubMed Articles [9297 Associated PubMed Articles listed on BioPortfolio]

Asymmetric Flow Field Flow Fractionation for the Characterization of Globule Size Distribution in Complex Formulations: A Cyclosporine Ophthalmic Emulsion Case.

Commonly used characterization techniques such as cryogenic-transmission electron microscopy (cryo-TEM) and batch-mode dynamic light scattering (DLS) are either time consuming or unable to offer high ...

Ocular irritation and cyclosporine A distribution in the eye tissues after administration of solid lipid microparticles in the rabbit model.

The aim of this study was to investigate the in vivo effect of Solid Lipid Microparticles (SLM), proposed for topical ocular administration of cyclosporine, on the rabbit eye. SLM carrier is an aqueou...

Application of Ultra-Centrifugation and Bench-TopF NMR for Measuring Drug Phase Partitioning for the Ophthalmic Oil-in-Water Emulsion Products.

Generic drug products are expected to have the same active pharmaceutical ingredient (API) (Q1) with the same content (Q2) and microstructure arrangement (Q3) as the innovator product. In complex oil-...

Evaluating the novel application of cyclosporine 0.1% in ocular surface disease.

Ocular surface disease (OSD) is a highly prevalent symptomatic condition caused by dry eye disease (DED), intrinsic, environmental, or iatrogenic causes. It affects patient's visual function and quali...

Pediatric pustular psoriasis responsive to cyclosporine bridged to etanercept: A treatment approach.

Pustular psoriasis occurs rarely in children but can present with acute toxicity requiring inpatient admission. For the best approach, medical providers should have an evidence based and systematic tr...

Medical and Biotech [MESH] Definitions

Deformities in nail structure or appearance, including hypertrophy, splitting, clubbing, furrowing, etc. Genetic diseases such as PACHYONYCHIA CONGENITA can result in malformed nails.

A sensory branch of the trigeminal (5th cranial) nerve. The ophthalmic nerve carries general afferents from the superficial division of the face including the eyeball, conjunctiva, upper eyelid, upper nose, nasal mucosa, and scalp.

Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.

A 17-KDa cytoplasmic PEPTIDYLPROLYL ISOMERASE involved in immunoregulation. It is a member of the cyclophilin family of proteins that binds to CYCLOSPORINE.

An emulsion of solid color which when spread over a surface leaves a thin decorative and or protective coating.

More From BioPortfolio on "Restasis for Treatment of Brittle Nails"

Quick Search


Relevant Topic

Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Searches Linking to this Trial