Analysis of Impact of KeryFlex on Quality of Life for Retronychia or Lichen Planus Adult Patients
Condition: Lichen Planus of Nail
MeSH terms: Lichen Planus
Study type: Interventional

Summary: 
      The purpose of this study is to assess the overall effect of KeryFlex study intervention on
      quality of life and functionality for patients with retronychia or nail lichen planus.
    

Detailed description: 
      Retronychia is the growth of the proximal nail plate into the proximal nail fold which was
      first described in 1999 by De Berker and Rendall. The disorder is common and most frequently
      affects women (~82%); the estimated average age is 39 years. The unilateral hallux is the
      most commonly diagnosed site, though nails of the hand (especially thumb and index finger)
      may also be affected. Common triggers of retronychia include minor trauma (e.g., wearing
      poorly fitting shoes, jogging,) and systemic illness (e.g., arthritis, thrombophlebitis),
      which cause disruption of the longitudinal nail bed growth and ultimately lead to the new
      plate growing vertically into the proximal nail fold. The most frequent cause is trauma.
      Clinical symptoms include pain, inflammation of the proximal nail fold, granulation tissue
      under the proximal nail fold, and changes in the proximal nail plate such as thickening or
      yellowing. Diagnosis is confirmed by clinical presentation and ultrasound. Treatment is
      particularly challenging. Topical corticosteroids have been used with favorable results;
      however, recurrences are frequent. Complete nail avulsion is used for severe and/or
      recalcitrant cases, but this is also associated with frequent relapse rates.

      Lichen planus is a chronic inflammatory dermatosis involving mucocutaneous surfaces, scalp,
      and nails. Nail involvement is observed in around 10% of patient and typically affects the
      fingernails more than toenails. Nail lichen planus can cause extensive scarring and nail
      loss. Permanent dystrophy in the forms of anonychia and dorsal pterygium has both functional
      and psychological consequences. Diagnosis is typically clinical, but a punch biopsy of the
      nail matrix or nail bed may be utilized if a diagnosis is questionable. There is no
      evidence-based management for nail lichen planus to date, though expert consensus recommends
      intralesional steroid injections or systemic corticosteroids as first-line treatment.
      Outcomes are inconsistent with steroid treatment.

      KeryFlex nail is defined as a cosmetic by the Food and Drug Administration (FDA). KeryFlex is
      a painless, in-office aesthetic application of acrylic nails which improves the appearance of
      nails damaged by various nail disorders. The composite resin creates a flexible, nonporous
      nail that allows the remaining natural nail to grow. KeryFlex is composed of a resin material
      which is applied on the affected nails following the next steps: debridement of the nail,
      application of bond, application of the resin in the desired color, shape, and size, and
      curing of the resin by an ultraviolet light. The typical interval between KeryFlex
      applications is 6 to 8 weeks.

      Application of an artificial resin nail to the affected digit may help counter burdensome
      effects of retronychia or nail lichen planus, including impaired social interactions and loss
      of functionality. There are no other options for symptom management of retronychia or nail
      lichen planus in the literature to our knowledge. Attachment of an artificial nail to the
      newly growing nail may also prevent distal embedding caused by dorsal expansion of the distal
      pulp, a possible complication of the loss of counterpressure induced by the loss of the nail
      plate after total nail avulsion.6 Nail resin will be applied as part of the study.
      Importantly, patients with retronychia very often report that their nail does not grow as
      quickly as the non-affected ones. Therefore, Keryflex application may be particularly useful
      if these patients, considering that they would not need to replace the Keryflex as often.

      KeryFlex, Pod-Advance, Inc. will provide necessary equipment, but it does not pay Weill
      Cornell Medicine to conduct this study.

      At the screening visit, potential participants will be screened by inclusion and exclusion
      criteria. History will be obtained including review of medications. Nail clipping sample for
      histopathology will be taken to rule out onychomycosis if a diagnosis of retronychia is
      unclear.

      Patients will be consented and at baseline visit, during which patients will also be asked to
      take a quality of life survey to assess baseline impact of retronychia on quality of life.
      Pre-treatment photographs of patient toenails will be taken. KeryFlex will then be applied to
      patients' affected nails.

      Patients will come to clinic eight weeks after baseline visit, at which point patients will
      be asked to take a repeat quality of life and satisfaction survey. Post-treatment photographs
      of patient resin nails will be taken. KeryFlex will then be removed, and photographs
      post-removal will be taken. The typical interval between KeryFlex application is 6 to 8
      weeks.

      At two-month follow up visit after KeryFlex treatment, patients will be asked to take a
      repeat quality of life and satisfaction survey. Post-treatment photographs of patient
      toenails will be taken. KeryFlex resin will be removed, and photographs post-removal will be
      taken.
    

Intervention name(s): KeryFlex
Intervention type(s): Other
Intervention description(s): KeryFlex is a painless, in-office cosmetic application of artificial nails which improves the appearance of nails damaged by various nail disorders. The composite resin creates a flexible, nonporous nail that allows the remaining natural nail to grow. KeryFlex is a three-step procedure that takes 10 to 15 minutes for a typical nail. At least 15% of the existing nail must be present for the resin application. The material used in KeryFlex is approved as a cosmetic by the FDA.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Retronychia; KeryFlex