Efficacy of Evonail® Solution in the Prevention of Nail Damage Induced by Docetaxel in Patients With Breast Cancer.

Study of the Effectiveness of the Film-forming Solution Evonail® Versus Placebo in the Prevention of Nail Damage Induced by Docetaxel in Patients With Breast Cancer.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02870699

Acronym

EVONAIL

Enrollment

Registered

2016-08-17

Start date

2011-10-31

Completion date

2016-06-30

Last updated

2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Carcinoma

Keywords

chemotherapy neoadjuvant

Brief summary

Docetaxel is widely used in oncology for the treatment of many solid tumors. The side effects of docetaxel are many and sometimes serious. The primary toxicity of docetaxel is neutropenia. Skin and nail manifestations, frequency, the second category of adverse events after haematological adverse events. Use of the product Evonail® was demonstrated in a patient treated by doxetaxel and having nail damage. The purpose of this study is to confirm the effectiveness of the film-forming solution Evonail® versus a placebo on the prevention of nail damage in women with breast cancer and treated by adjuvant docetaxel.

Interventions

DEVICEEvonail

film-forming solution containing water Evaux naturally rich in lithium, strontium and manganese with UV filter

DEVICEPlacebo excipient

film forming excipient solution

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥ 18 years old * Patient with breast carcinoma * Patients treated with adjuvant chemotherapy (FEC + 3 docetaxel +/- Herceptin®) * Patients who have never been treated with taxanes * Patients with no nail damage before starting the study * ECOG performance \< 2 * Ability to provide written informed consent

Exclusion criteria

* Patient allergic to any of the treatment components * Use of film-forming solution, solvents or any other products applied to the fingernails (artificial nails ...) in three weeks before the first of docetaxel treatment * Risk of exposure to aggressive factors nail during the study * Using refrigerants gloves during chemotherapy treatments * Onychophagia * Presence of nail disease or a history of nail pathology (infectious and other) * Pregnant or breast feeding females * Patients whose condition is not compatible with the follow-up study

Design outcomes

Primary

Measure	Time frame	Description
Efficacy of the film-forming solution Evonail® versus placebo on nail damage	up to 9 weeks	Efficacy will be evaluated by the oncologist according to NCI-CTC

Secondary

Measure	Time frame	Description
Patient satisfaction regarding the use of the film-forming solution Evonail®	up to 9 weeks	Patient satisfaction will be evaluated using a questionnaire
Different types of nail damage observed in each group after chemotherapy docetaxel	up to 9 weeks	Nail damage will be evaluated by the dermatologist based on photography according to NCI-CTC
Patient compliance for the film-forming solution Evonail®	up to 9 weeks	Patient compliance will be evaluated using a questionnaire

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026