Analysis of Impact of KeryFlex on Quality of Life for Retronychia or Lichen Planus Adult Patients

October 6, 2023 updated by: Weill Medical College of Cornell University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Dermatology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  • Diagnosis of retronychia or nail lichen planus
  • Able to understand and voluntarily sign an informed consent form
  • 18-95 years old at time of consent
  • Able to adhere to the study visit schedule and other protocol requirements

Exclusion criteria:

  • Unable to provide written informed consent for any reason
  • Diagnosis of peripheral vascular disease, arterial insufficiency, peripheral neuropathy, suspicious pigmented lesions on the nail or in-grown nails
  • Sensitive or allergic to any KeryFlex ingredients
  • Unable to abstain from using nail polishes, nail gels, or any other nail products 2 days prior to KeryFlex procedure and during the study period
  • Pregnant, planning pregnancy, or nursing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KeryFlex
Patients 18 years and older presenting with retronychia and/or lichens planus of the toenails and/or fingernails to the Weill Cornell Medicine, Department of Dermatology, specialized nail clinic.
Other: KeryFlex
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in social domain of quality of life, as measured by social domain scale
Time Frame: Baseline; Week 8

A three-item social domain scale

Total possible low score in quality of life, social domain: 0 (0=worst quality of life, social domain) Total possible high score in quality of life, social domain: 100 (100=best quality of life, social domain)
Baseline; Week 8
Change in emotional domain of quality of life, as measured by emotional domain scale
Time Frame: Baseline; Week 8

A seven-item emotional domain scale

Total possible low score in quality of life, emotional domain: 0 (0=worst quality of life, emotional domain) Total possible high score in quality of life, emotional domain: 100 (100=best quality of life, emotional domain)
Baseline; Week 8
Change in symptoms domain of quality of life, as measured by symptoms domain scale
Time Frame: Baseline; Week 8

A three-item symptoms domain scale

Total possible low score in quality of life, symptoms domain: 0 (0=worst quality of life, symptoms domain) Total possible high score in quality of life, symptoms domain: 100 (100=best quality of life, symptoms domain)
Baseline; Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Shari R Lipner, MD PhD, Weill Cornell Dermatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2023

Primary Completion (Actual)

September 28, 2023

Study Completion (Actual)

September 28, 2023

Study Registration Dates

First Submitted

January 17, 2023

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Actual)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-04024687

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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