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

Sponsor

Stratpharma AG (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05810194

Collaborator

(none)

400

Enrollment

Location

Anticipated Duration (Months)

49.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Radiation Dermatitis	Device: StrataXRT Drug: Calendula Drug: Aquaphor

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
StrataXRT	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.
Standard of care	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.

Arm

Intervention/Treatment

StrataXRT

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.

Standard of care

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.

Outcome Measures

Primary Outcome Measures

CTCAE for Radiation Dermatitis [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 Outcome Measures

CTCAE for Hyperpigmentation [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.
Number of patients requiring burn cream application [5 weeks]
Total number of patients that required burn cream application during radiotherapy
Interval between radiotherapy start and burn cream application [5 weeks]
Number of days between initiation of radiation therapy and first application of burn cream during radiotherapy
Number of patients requiring Mepilex application [5 weeks]
Total number of patients that required Mepilex application during radiotherapy
Interval between radiotherapy start and Mepilex application [5 weeks]
Number of days between initiation of radiation therapy and first application of Mepilex during radiotherapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California	Los Angeles	California	United States	90095

Sponsors and Collaborators

Stratpharma AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stratpharma AG

ClinicalTrials.gov Identifier:

NCT05810194

Other Study ID Numbers:

SPASX020

First Posted:

Apr 12, 2023

Last Update Posted:

Apr 14, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Dermatitis

Radiodermatitis

Study Results

No Results Posted as of Apr 14, 2023