NCT05450848

StrataXRT vs. Standard Clinical Practice in the Prevention and Treatment of Radiation Dermatitis

A Randomised Comparison of StrataXRT to Standard Clinical Practice in the Prevention and Treatment of Radiation Dermatitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Stratpharma AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Current clinical practice for preventing and treating radiation dermatitis across Queensland (QLD) Health Radiation Oncology departments involves the application of aqueous cream daily to the skin of the treatment site, commencing from Day 1 of EBRT. The primary aim of this study is to assess the efficacy of StrataXRT when compared to current clinical practice in preventing and managing radiation dermatitis.

Conditions

• Radiation Dermatitis

Interventions

Type	Name	Description
DEVICE	StrataXRT	StrataXRT is a flexible wound dressing for the prevention and treatment of radiation dermatitis. It is in the form of a gel which, when applied, creates a protective film that maintains skin integrity. The product is used to relieve low grade inflammatory radiation changes such as dry, itching, flaking, peeling and irritated skin. For more severe inflammatory changes with open wound components, StrataXRT reduces pain, redness and heat and helps soothe the exposed skin areas. StrataXRT can be applied where skin integrity has been compromised and may also be used in conjunction with other adjunctive treatments to improve overall results. StrataXRT contains Polydimethylsiloxanes, Siloxanes and Alkylmethyl Silicones and is transparent and odourless. It does not contain alcohols, parabens or fragrances. StrataXRT can be used with or without a secondary protective dressing. It is suitable for children and people with sensitive skin.
OTHER	Sorbolene	Aqueous cream (moisturizer) that soothes itchiness and dryness of the skin, and aids skin hydration. It is non-greasy, fragrance free, colour free, GMO free, paraben free and pH balanced.

Timeline

• Start date: 2017-09-01
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2022-07-11
• Last updated: 2023-07-12

Locations

2 sites across 1 country: Australia