NCT05553392

StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis

StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis in Cancer Patients Receiving Elective Inguinal Radiation Therapy

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Stratpharma AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess the efficacy and safety of StrataXRT® in comparison to standard of care (defined using the Common Terminology Criteria for Adverse Events \[CTCAE\], version 5.0) by assessing the severity of inguinal RD in patients receiving elective radiation therapy +/- systemic therapy to the bilateral inguinal nodes.

Conditions

• Radiation Dermatitis

Interventions

Type	Name	Description
DEVICE	StrataXRT	StrataXRT is a full contact flexible wound dressing for the prevention and treatment of radiation dermatitis. StrataXRT is a semi-occlusive, self-drying and transparent gel. When used as directed StrataXRT dries to form a protective layer that is gas permeable and waterproof which hydrates and protects compromised skin areas and superficial wounds from chemical and microbial invasion. StrataXRT may be directly applied to radiation dermatitis, compromised skin surfaces, superficial wounds and first and second degree burns.
DRUG	Aquaphor	Aquaphor is a brand of over-the-counter (OTC) skin care ointments manufactured by Beiersdorf Inc. Aquaphor contains 41 percent petrolatum (or petroleum jelly), the active ingredient, temporarily protects minor cuts, scrapes, and burns; protects and helps relieve chapped or cracked skin and lips; helps protect from the drying effects of wind and cold weather.

Timeline

• Start date: 2022-11-01
• Primary completion: 2024-05-30
• Completion: 2024-05-30
• First posted: 2022-09-23
• Last updated: 2024-09-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study