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
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