L58.0
Conditions
Interventions
Group 1: In this group, the investigational product (Linola Radio-Derm Hair & Body) is used.
Group 2: In this group, subject's own cleansing product is used.
Sponsors
Dr. August Wolff GmbH & Co. KG Arzneimittel
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - 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 scale.
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of clinical signs and symtoms: On Day1 and Day 22, the physician will evaluate the skin status according to the following scales: Scabs, Dryness, Oedema (0=absent, 1=present). Desquamation, Erythema (0=absent, 1=very slight, 2=slight, 3=moderate, 4=severe). Vesicles, Papules, Bullae (0=absent, 1=presence of 1 or 2 elements, 2=presence of numerous elements). | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiation Therapy Oncology Group (RTOG) Grading System: On Days 1, 15 and 22, the physician will evaluate the skin status according to the RTOG grading system: 0 = No visible change to skin. 1 = Faint or dull erythema. Mild tightness of skin and itching may occur. 2 = Bright erythema / dry desquamation. Sore, itchy and tight skin. 2.5 = Patchy moist desquamation Yellow/pale green exudate. Soreness with oedema. 3 = Confluent moist desquamation. Yellow/pale green exudate. Soreness with oedema. 4 = Ulceration, bleeding, necrosis. | — |
Countries
Germany
Contacts
Public ContactSophia Pachmann
Praxis für Strahlentherapie und Radioonkologie
Outcome results
None listed