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

NCT ID: NCT02670603

Last Updated: 2017-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Docetaxel Chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
This study is open-labeled study. But outcome would be assessed the statistician who did not involve this study with blind data.

Study Groups

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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.

Group Type EXPERIMENTAL

EVONAIL® solution

Intervention Type DRUG

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.

Group Type OTHER

EVONAIL® solution

Intervention Type DRUG

Interventions

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EVONAIL® solution

Intervention Type DRUG

Other Intervention Names

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Hydrating Nail Solution

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Yeon Hee Park

MD,Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Kim JY, Ok ON, Seo JJ, Lee SH, Ahn JS, Im YH, Park YH. A prospective randomized controlled trial of hydrating nail solution for prevention or treatment of onycholysis in breast cancer patients who received neoadjuvant/adjuvant docetaxel chemotherapy. Breast Cancer Res Treat. 2017 Aug;164(3):617-625. doi: 10.1007/s10549-017-4268-7. Epub 2017 May 9.

Reference Type DERIVED
PMID: 28488142 (View on PubMed)

Other Identifiers

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2015-04-018-002

Identifier Type: -

Identifier Source: org_study_id

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