A Trial of Evonail® Solution for Prevention or Treatment of Onycholysis

Overview

This study is a prospective randomized controlled study of EVONAIL® solution for prevention or treatment of onycholysis in patients with breast cancer receiving docetaxel chemotherapy.

Full Title of Study: “A Prospective Randomized Controlled Trial of Evonail® Solution for Prevention or Treatment of Onycholysis in Breast Cancer Patients Who Received Neoadjuvant/Adjuvant Docetaxel Chemotherapy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 2016

Interventions

  • Drug: EVONAIL® solution

Arms, Groups and Cohorts

  • Experimental: Experimental arm
    • In experimental arm, each patient painted EVONAIL® solution on nails and periungual areas once a day till developing onycholysis grade 2 or more.
  • Other: Control arm
    • In control arm, each patient painted EVONAIL® solution on nails and periungual area twice a day after developing onycholysis grade 2. This study design allowed cross-over. Therefore, this control arm would give EVONAIL® solution after developing onlycholysis grade 2 in spite of control arm.

Clinical Trial Outcome Measures

Primary Measures

  • The incidence of onycholysis Gr 2 or more
    • Time Frame: 12weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with breast cancer receiving adjuvant/neoadjuvant docetaxel chemotherapy Exclusion Criteria:

  • Patients with breast cancer receiving palliative docetaxel chemotherapy – Patients having onycholysis before docetaxel treatment

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Samsung Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yeon Hee Park, MD,Ph.D – Samsung Medical Center

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.