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NCT Number: NCT05810194

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. CTCAE for Radiation Dermatitis

    Time frame: 5 weeks

    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.

Secondary outcomes

  1. CTCAE for Hyperpigmentation

    Time frame: 5 weeks

    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.

  2. Number of patients requiring burn cream application

    Time frame: 5 weeks

    Total number of patients that required burn cream application during radiotherapy

  3. Interval between radiotherapy start and burn cream application

    Time frame: 5 weeks

    Number of days between initiation of radiation therapy and first application of burn cream during radiotherapy

  4. Number of patients requiring Mepilex application

    Time frame: 5 weeks

    Total number of patients that required Mepilex application during radiotherapy

  5. Interval between radiotherapy start and Mepilex application

    Time frame: 5 weeks

    Number of days between initiation of radiation therapy and first application of Mepilex during radiotherapy

Sponsors and collaborators

Lead sponsor

Stratpharma AG

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2023
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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