Skin Cleansing during Radiotherapy - Open label randomized Application - SKICRAT

Dr. August Wolff GmbH & Co. KG Arzneimittel0 个研究点目标入组 40 人开始时间: 2021年9月17日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Gender: Female;
•- Age: over 18 years of age;
•- Having signed an Informed Consent Form (ICF);
•- Willingness, ability and likeliness to comply with all the study procedures and restrictions;
•- Available during the entire study period;
•- Suffering from breast cancer;
•- Going to be submitted to a 16-21 sessions radiotherapy treatment (with a duration of 3-
•4 weeks). For all subjects, the radiotherapy treatment during the first 3 weeks (16 sessions)
•has to be equivalent, because only this period will be relevant for this study;
•- Presenting skin phototype between I and IV according to the Fitzpatrick phototyping

•- Known allergy or known history of hypersensitivity to the components of the
•investigational products and/or related compounds (including documented allergies to
•skin care and/or skin cleansing products);
•- Currently participating or being in the waiting period after the participation in a
•cosmetic and/or pharmaceutical clinical study pertaining to the test area that may
•interfere with the present study;
•- Having diseases that may impair the study (including, but not limited to: AIDS, HIVpositive
•or infectious hepatitis, active skin diseases on the test area);
•- With conditions which exclude a participation or might influence the test
•reaction/evaluation;
•- Under pharmacological treatments that may impair the study (including, but not limited
•to: currently doing chemotherapy; not including: all treatments related to breast cancer);
•- With skin conditions and/or cutaneous alterations on the test area that can impair the
•study (E.g. scars, tattoos, marks, burns, wounds, moles, etc.);
•- Pregnancy or intention to conceive during the study;
•- Breast-feeding.

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