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

Radiation Dermatitis Clinical Trial

Official title:

Retrospective Cohort Study Comparing a Novel Silicone Gel Wound Dressing vs Standard of Care in the Treatment of Radiation Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05810194
• Other study ID #: SPASX020
• Status: Completed
• Start date: May 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Stratpharma AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Routinely collected data on radiation-induced skin toxicity from 2010 to 2022 will be retrospectively analyzed. Data will be split into two cohorts: patients that received 1) StrataXRT and 2) standard of care. The incidence of grade ≥ 2 radiation dermatitis, the time to onset of grade ≥ 2 radiation dermatitis, the radiation dose at onset of grade ≥ 2 radiation dermatitis, the incidence of moist desquamation and the number of treatment interruptions will be compared between the cohorts.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 344
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with Head and Neck cancer treated with radiation therapy with or without chemotherapy
• Fractionated courses including at least 30 fractions (treatments)
• Minimum of 18 completed radiation treatments
• Radiation dose: > 50 Gy
• Radiation technique: IMRT
• Radiation equipment: TrueBeam or Tomotherapy

Exclusion Criteria:

• Prior radiation to the treatment area
• Patients with any medical condition such as active connective tissue disorder that predisposes them to an increased risk of potentially severe radiation dermatitis.
• Patients undergoing SBRT
• Patients with existing rashes or wounds in the target region or radiation therapy at RT start
• Patients receiving hypofractionation
• Patient receiving bolus

Related Conditions & MeSH terms

• Dermatitis
• Radiation Dermatitis
• Radiodermatitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Stratpharma AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CTCAE for Radiation Dermatitis	Acute radiation dermatitis measured weekly during radiotherapy treatment, using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 score (grade 0 - 5). A higher grade is considered a worse outcome.	5 weeks
Secondary	CTCAE for Hyperpigmentation	Acute hyperpigmentation measured weekly during radiotherapy treatment, using the Common Terminology Criteria for Adverse Events (CTCAE) score (grade 0 - 2). A higher grade is considered a worse outcome.	5 weeks
Secondary	Number of patients requiring burn cream application	Total number of patients that required burn cream application during radiotherapy	5 weeks
Secondary	Interval between radiotherapy start and burn cream application	Number of days between initiation of radiation therapy and first application of burn cream during radiotherapy	5 weeks
Secondary	Number of patients requiring Mepilex application	Total number of patients that required Mepilex application during radiotherapy	5 weeks
Secondary	Interval between radiotherapy start and Mepilex application	Number of days between initiation of radiation therapy and first application of Mepilex during radiotherapy	5 weeks