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

Samsung Medical Center

Status: Completed

Conditions: Breast Cancer; Docetaxel Chemotherapy

Treatments: Drug: EVONAIL® solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02670603

2015-04-018-002

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Experimental arm

Experimental group

Description:

In experimental arm, each patient painted EVONAIL® solution on nails and periungual areas once a day till developing onycholysis grade 2 or more.

Treatment:

Drug: EVONAIL® solution

Control arm

Other group

Description:

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.

Treatment:

Drug: EVONAIL® solution