NCT02334345

Brief Summary

Radiotherapy may cause severe skin changes that significantly interfere with the patient's quality of life and may reduce radiotherapy effectiveness. Many skin care instructions and various topical agents are recommended to help patients in the management of radiation skin reactions, but evidence to support the value of the topical treatments of the irradiated skin is lacking. In the present study we investigated the effects of two topical agents used as supportive care to protect skin during radiotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2014

Completed
16 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 8, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2021

Completed
Last Updated

March 14, 2022

Status Verified

February 1, 2022

Enrollment Period

10 months

First QC Date

December 16, 2014

Last Update Submit

February 27, 2022

Conditions

Radiation Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Average of the radiation dermatitis intensity

    Radiation dermatitis will be assessed by means of a spectrophotometer after the patient has received 50Gy

    at 3 months

Secondary Outcomes (1)

  • Clinical grade of dermatitis

    at 3 months

Study Arms (2)

EVOSKIN

EXPERIMENTAL

Patients are to apply Evoskin ( topical agent) in the half of the irradiated breast 3 hours after radiothérapy and may be applied again later the same day.

Drug: Evoskin

TRIXIERA

ACTIVE COMPARATOR

Patients are to apply Trixiera ( topical agent) in the other half of the irradiated breast 3 hours after radiothérapy and may be applied again later the same day.

Drug: Trixiera

Interventions

EvoskinDRUG

Evoskin is Trixiera is a topical agent recommended to help patients in the management of radiation skin reactions

EVOSKIN
TrixieraDRUG

Trixiera is a topical agent recommended to help patients in the management of radiation skin reactions

TRIXIERA

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old or more
  • Patients with breast cancer for which a treatment by radiotherapy is planned
  • No concomitant chemotherapy
  • Signed informed consent

You may not qualify if:

  • Cutaneous neoplasia radiotherapy
  • Total mastectomy
  • Bilateral breast cancer
  • Dark skinDiseases enhancing radiosensitivity Patient with a generalized skin disorder
  • Pregnant, breast-feeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU LIMOGES - Radiothérapie

Limoges, 87000, France

Location

MeSH Terms

Conditions

Radiodermatitis

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesRadiation InjuriesWounds and Injuries

Study Officials

  • Pierre CLAVRE, MD

    CHU LIMOGES

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2014

First Posted

January 8, 2015

Study Start

January 1, 2015

Primary Completion

November 1, 2015

Study Completion

January 17, 2021

Last Updated

March 14, 2022

Record last verified: 2022-02

Locations

FR(1)