Trial to evaluate the safety and performance of Deumavan® at Radiodermatitis

Not Applicable

Recruiting

• Conditions: Radiodermatitis

• Registration Number: DRKS00023145
• Lead Sponsor: Kaymogyn GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Male and female patients aged 18 years
- Presence of an anogenital tumor (anal canal and anal rim carcinoma, vulvar carcinoma, penile carcinoma, rectum carcinoma of the lower third or with involvement of the sphincter muscle) with an indication for definitive or adjuvant radiation of the tumor and / or the pelvic or inguinal lymphatic drainage pathways
- Target total radiation dose = 40 Gy
- Life expectancy> 6 months
- Signed declaration of consent before starting the study

Exclusion Criteria

- Pregnant or breastfeeding women
- Previous radiation in the current radiation area
- Participation in a clinical trial within the last 30 days
- Hypersensitivity or allergy to one or more of the ingredients in Deumavan®
- Patients with existing high-grade skin diseases in the radiation area that require treatment
- Patients incapable of giving consent (according to MPG Section 20, Paragraph 2, Clause 1, No. 1)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The doctor in charge assesses the presence of radiodermatitis at the time of the examination, taking into account the severity using the CTCAE criteria (CTCAE version 5.0). On the one hand, the frequency of occurring radiodermatitis will be considered and, on the other hand, its severity.

Secondary Outcome Measures

Name	Time	Method
- Detection of skin-associated (S) AEs<br>- Recording of product-related (S) AE, incidents<br>- Assessment of symptoms and impairment of quality of life (assessment of radiation-induced skin reaction)<br>- Assessment of the tolerability of Deumavan® by the patient on the basis of school grades<br>- Assessment of the effectiveness of Deumavan® with regard to the prophylaxis and treatment of radiodermatitis by the doctor based on school grades<br>- Changes in the CTCAE between baseline and subsequent visits<br>- Patient compliance by keeping a diary