StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis

NCT05553392 | Terminated FDA Device

• 1 other identifier: SPASX018
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the efficacy and safety of StrataXRT® in comparison to standard of care (defined using the Common Terminology Criteria for Adverse Events \[CTCAE\], version 5.0) by assessing the severity of inguinal RD in patients receiving elective radiation therapy +/- systemic therapy to the bilateral inguinal nodes.

Conditions

Radiation Dermatitis

Outcome Measures

Primary Outcomes (1)

• Incidence of acute >grade 2 radiation dermatitis

  The Common Terminology Criteria for Adverse Events (CTCAE- Version 5.0) will be used to assess the severity of RD (19). This instrument is routinely used and well validated in radiation oncology for assessing radiation dermatitis (20). This weekly assessment will be undertaken by the assessor who is blinded to the allocation. The assessor will be instructed prior to the first fraction of radiation therapy to score the worst toxicity present, at the time of assessment within the treatment field which consists of the bilateral inguinal regions. The amount of \> grade 2 RD cases will be compared in both study groups.

  Until 8 weeks post radiation therapy; up to 4 months

Secondary Outcomes (4)

• Average toxicity assessed using the CTCAE

  Until 8 weeks post radiation therapy; up to 4 months

• Time to onset of moist desquamation

  Until 8 weeks post radiation therapy; up to 4 months

• Pain scores

  Until 8 weeks post radiation therapy; up to 4 months

• Itchiness score

  Until 8 weeks post radiation therapy; up to 4 months

Study Arms (2)

StrataXRT

EXPERIMENTAL

Studied products will be applied as per the patient information leaflet following manufacturer guidelines to the treatment area. The studied products will be used starting on the first day of radiation therapy. The studied products will be applied twice a day to both the right and left inguinal regions. The studied products will be used daily during the entire course of radiotherapy including on weekends and holidays until at least 4 weeks upon completion of radiation therapy or otherwise until resolution of RD on both sides.

Device: StrataXRT

Aquaphor

ACTIVE COMPARATOR

Studied products will be applied as per the patient information leaflet following manufacturer guidelines to the treatment area. The studied products will be used starting on the first day of radiation therapy. The studied products will be applied twice a day to the entire treatment field. The studied products will be used during the entire course of radiotherapy and for a further 4 weeks upon completion of radiation therapy.

Drug: Aquaphor

Interventions

StrataXRT DEVICE

StrataXRT is a full contact flexible wound dressing for the prevention and treatment of radiation dermatitis. StrataXRT is a semi-occlusive, self-drying and transparent gel. When used as directed StrataXRT dries to form a protective layer that is gas permeable and waterproof which hydrates and protects compromised skin areas and superficial wounds from chemical and microbial invasion. StrataXRT may be directly applied to radiation dermatitis, compromised skin surfaces, superficial wounds and first and second degree burns.

StrataXRT

Aquaphor DRUG

Aquaphor is a brand of over-the-counter (OTC) skin care ointments manufactured by Beiersdorf Inc. Aquaphor contains 41 percent petrolatum (or petroleum jelly), the active ingredient, temporarily protects minor cuts, scrapes, and burns; protects and helps relieve chapped or cracked skin and lips; helps protect from the drying effects of wind and cold weather.

Aquaphor

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age or older
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Life expectancy of at least 6 months
• Biopsy-confirmed malignancy without gross nodal involvement of the right or left inguinal regions
• Patients will receive elective radiation therapy to bilateral inguinal nodal regions prescribed to 45-50 Gy in 1.8-2 Gy fractions using photon or proton therapy
• No known allergy to studied products
• Able to give written informed consent, or have written consent given on their behalf
• Patients who are able and willing to attend the post-radiation weekly skin assessment appointments
• Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Abstinence is acceptable if preferred by patient. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.

You may not qualify if:

• Patients with gross cancer involvement of either or both inguinal regions.
• Patients who have received prior pelvic and/or inguinal radiation therapy.
• Patients who cannot apply the studied products to the inguinal region or have it administered to them as required by this study.
• Patients with any medical condition such as active connective tissue disorder that predisposes them to an increased risk of potentially severe radiation dermatitis.
• Patients with existing rashes or wounds in either inguinal region at baseline.
• Planned inguinal dissection within 90 days after completion of radiation therapy on this study.
• Female patients who are pregnant or breast feeding.
• Patients who are unable to give written informed consent, or are unable to have written consent given on their behalf.

Sponsors & Collaborators

• Stratpharma AG: lead

Study Sites (1)

Miami Cancer Institute

Miami, Florida, 33176, 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: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 23, 2022
• Study Start: November 1, 2022
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)