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CompletedNCT02670603Updated Apr 28, 2017

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

An interventional study of EVONAIL® solution in Breast Cancer and Docetaxel Chemotherapy, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-28.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Aug 2015, registered Jan 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Sex
Female
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Study 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.

02

Conditions studied

  • Breast Cancer
  • Docetaxel Chemotherapy

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 100 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients with breast cancer receiving adjuvant/neoadjuvant docetaxel chemotherapy

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • 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
    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

Interventions

  • DrugEVONAIL® solution

    Also known as: Hydrating Nail Solution

06

What researchers measure

Primary outcomes

  1. The incidence of onycholysis Gr 2 or more

    Time frame: 12weeks

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Study locations

1 site
  • Samsung Medical Center
    Seoul, 135-710, Korea, Republic of
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References and documents

Publications

  • 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. PubMed 28488142 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02670603
Lead sponsor
Samsung Medical Center
Responsible party
Yeon Hee Park (MD,Ph.D, Samsung Medical Center) — Principal investigator
First posted
Feb 2, 2016
Start date
Aug 2015
Primary completion
Jun 2016
Completion
Sep 2016
Last update
Apr 28, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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