Retrospective Cohort Study Comparing a Novel Gel Dressing vs SoC in the Treatment of Radiation Dermatitis

CompletedOBSERVATIONAL
Enrollment

344

Participants

Timeline

Start Date

May 1, 2023

Primary Completion Date

September 30, 2023

Study Completion Date

December 31, 2023

Conditions
Radiation Dermatitis
Interventions
DEVICE

StrataXRT

StrataXRT® is a TGA-approved silicone-based topical preparation. StrataXRT is a self-drying, non-sticky, transparent, silicone gel formulation and when used as directed, dries to form an inert, thin, flexible wound dressing with a protective layer that is gas permeable and waterproof. It is the only self-drying topical silicone gel indicated for the use on radiation dermatitis, which hydrates and protects compromised skin areas and open wounds from chemical and microbial invasion. StrataXRT helps create an optimal wound healing environment which leads to faster re-epithelialization and a reduced inflammatory response. The product can be applied to fresh incisions and excisions, open wounds and compromised skin surfaces.

DRUG

Calendula

Calendula creams are over-the-counter (OTC) skin care ointments that are non-greasy, non-sticky, and quickly absorbed by the skin. Calendula is a topical agent derived from a plant of the marigold family Calendula Officinalis and is used in cuts, scrapes, chafing and minor burns. Containing numerous polyphenolic antioxidants, calendula has been studied in both the laboratory and clinical setting for the use in treating and preventing radiation induced skin toxicity.

DRUG

Aquaphor

Aquaphor, containing 41 percent petrolatum (or petroleum jelly), temporarily protects minor cuts, scrapes, and burns; Aquaphor protects and helps relieve chapped or cracked skin and lips, as well as helps protecting from the drying effects of wind and cold weather.

Trial Locations (1)

90095

University of California, Los Angeles

All Listed Sponsors
lead

Stratpharma AG

INDUSTRY