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

NCT05810194 | Completed FDA Device

• 1 other identifier: SPASX020
• Study Type: observational
• Target: 344
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Radiation Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• CTCAE for Hyperpigmentation

  5 weeks

• Number of patients requiring burn cream application

  5 weeks

• Interval between radiotherapy start and burn cream application

  5 weeks

• Number of patients requiring Mepilex application

  5 weeks

• Interval between radiotherapy start and Mepilex application

  5 weeks

Study Arms (2)

StrataXRT

Device: StrataXRT

Standard of care

Drug: Calendula; Drug: Aquaphor

Interventions

StrataXRT DEVICE

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.

StrataXRT

Calendula DRUG

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.

Standard of care

Aquaphor DRUG

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.

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Head and neck cancer patients treated with radiation therapy at UCLA from 2010 to 2022

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stratpharma AG: lead

Study Sites (1)

University of California

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Radiodermatitis

Interventions

Petrolatum

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hydrocarbons; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 12, 2023
• Study Start: May 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

US (1)