An interventional study of Evoskin and Trixiera in Radiation Dermatitis, sponsored by University Hospital, Limoges. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-14.
Sponsored by University Hospital, Limoges · Not applicable, Interventional, and Prevention
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.
Women with breast cancer and were to receive breast radiotherapy to 50 Gy were enrolled in a prospective randomized trial to compare the effectiveness of Evoskin®) for protecting skin compared to Trixiera. To account for individual differences in radiation each subject served as her own control, as each was to apply the experimental and control agents to the irradiated breast. Each patient was randomly assigned to use Evoskin on the half of the irradiated breast and to use the Triexiera on the other half. Dermatitis was graded weekly by means of a spectrophotometer.
139 studies on the registry are indexed under Radiodermatitis; 26 are open to participants now.
This study's enrollment of 25 is below the median of 55 across 114 interventional studies indexed under Radiodermatitis.
Browse Radiodermatitis studies →University Hospital, Limoges is the lead sponsor of 262 studies on the registry; 37 are open to participants now.
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Exclusion Criteria:
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
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
Evoskin is Trixiera is a topical agent recommended to help patients in the management of radiation skin reactions
Trixiera is a topical agent recommended to help patients in the management of radiation skin reactions
Average of the radiation dermatitis intensity
Radiation dermatitis will be assessed by means of a spectrophotometer after the patient has received 50Gy
Time frame: at 3 months
Clinical grade of dermatitis
dermatitis grade will be assessed according to CTCAE after the patient has received 50 Gy
Time frame: at 3 months
The record gives a start of Jan 2015, a primary completion of Nov 2015 and a completion of Jan 2021. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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