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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02670603
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Yeon Hee Park, Samsung Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Docetaxel Chemotherapy Drug: EVONAIL® solution Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: This study is open-labeled study. But outcome would be assessed the statistician who did not involve this study with blind data.
Primary Purpose: Supportive Care
Official Title: A Prospective Randomized Controlled Trial of Evonail® Solution for Prevention or Treatment of Onycholysis in Breast Cancer Patients Who Received Neoadjuvant/Adjuvant Docetaxel Chemotherapy
Actual Study Start Date : August 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: EVONAIL® solution
Other Name: Hydrating Nail Solution

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.

Drug: EVONAIL® solution
Other Name: Hydrating Nail Solution




Primary Outcome Measures :
  1. The incidence of onycholysis Gr 2 or more [ Time Frame: 12weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670603


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yeon Hee Park, MD,Ph.D, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02670603    
Other Study ID Numbers: 2015-04-018-002
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Breast Neoplasms
Onycholysis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Nail Diseases
Pharmaceutical Solutions