What side effects are associated with this type of intervention?

Common treatments for radiation skin damage, such as silicone-based gels like StrataXRT®, generally have minimal side effects. These treatments form a protective layer over the skin, which can help reduce inflammation and promote healing. However, some patients may experience mild skin irritation, redness, or itching at the application site. Other treatments for radiation dermatitis, such as topical corticosteroids and emollients, can also cause similar mild side effects. In rare cases, more severe reactions like allergic contact dermatitis may occur.

What prior FDA approvals exist?

There is limited specific information on FDA approvals for treatments exactly like StrataXRT® for radiation skin damage. However, silicone-based gels and creams, such as those containing silicone or other protective agents, are commonly used to manage radiation dermatitis. These treatments work by forming a protective barrier on the skin, reducing inflammation, promoting healing, and preventing further damage. Other similar treatments include topical corticosteroids and emollients, which are often recommended to alleviate symptoms and improve skin recovery in patients undergoing radiation therapy.

What other types of research exist?

Promising novel alternatives to StrataXRT® for radiation skin damage include: 1) Aquaphor, which is a well-established option for managing radiation dermatitis by providing a protective barrier and promoting healing. 2) Methyl aminolevulinate (MAL) cream used in daylight photodynamic therapy, which has shown efficacy in treating skin conditions with minimal pain and good patient tolerance. 3) Newer biologic agents like secukinumab and ixekizumab, which have demonstrated anti-inflammatory properties in various dermatological conditions and may offer benefits in managing radiation-induced skin damage.

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Topical Agent

StrataXRT vs Aquaphor for Radiation Dermatitis

N/A

Waitlist Available

Research Sponsored by Stratpharma AG

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Must not have

Patients who have received prior pelvic and/or inguinal radiation therapy

Female patients who are pregnant or breast feeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until 8 weeks post radiation therapy; up to 4 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing StrataXRT®, a skin treatment, to see if it works better than the current method for patients receiving radiation therapy to their groin area. The treatment creates a protective barrier on the skin to help reduce damage and aid healing. The goal is to find out if StrataXRT® can better manage skin problems caused by radiation. StrataXRT® is a silicone-based gel dressing used to prevent and treat skin issues from radiation.

Who is the study for?

Adults over 18 with a life expectancy of at least 6 months, receiving radiation therapy for malignancy without severe nodal involvement in the groin area. They must be able to attend weekly skin checks, have no allergies to products used in the study, and use contraception if necessary. Pregnant or breastfeeding women and those unable to consent or follow the treatment application protocol are excluded.

What is being tested?

The trial is testing StrataXRT against Aquaphor ointment for preventing and managing skin damage caused by radiation therapy in patients undergoing treatment to their groin nodes. The severity of skin reactions will be measured using established criteria.

What are the potential side effects?

Potential side effects may include varying degrees of skin irritation, redness, peeling or blistering where StrataXRT or Aquaphor is applied. These symptoms are related to both the underlying radiation dermatitis being treated and possible reactions to the treatments themselves.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I will undergo radiation therapy targeting the groin area with specific dosage and technique.

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I can take care of myself and am up and about more than half of the day.

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I am 18 years old or older.

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I can and will go to weekly skin checks after radiation.

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My cancer diagnosis was confirmed by a biopsy and it hasn't spread to the groin area.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation therapy in the pelvic or groin area before.

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I am not pregnant or breastfeeding.

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I am scheduled for groin surgery within 3 months after my radiation treatment.

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I have rashes or wounds near my groin area.

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I cannot use the study's products on my groin area as needed.

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I am able to give or have someone give written consent for me.

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I have a condition that increases my risk of severe skin reactions to radiation.

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My cancer has visibly spread to my groin area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until 8 weeks post radiation therapy; up to 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until 8 weeks post radiation therapy; up to 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and until 8 weeks post radiation therapy; up to 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of acute >grade 2 radiation dermatitis

Secondary study objectives

Average toxicity assessed using the CTCAE

Itchiness score

Pain scores

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: StrataXRTExperimental Treatment1 Intervention

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.

Group II: AquaphorActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

StrataXRT

2017

N/A

~450

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Silicone-based treatments like StrataXRT® work by forming a protective layer over the skin, which helps to reduce inflammation, promote healing, and prevent further damage. The mechanism involves occlusion and hydration of the stratum corneum, which enhances the skin's barrier function and facilitates cytokine-mediated signaling that promotes tissue repair. This is particularly important for patients with radiation skin damage as it helps to manage symptoms, improve skin integrity, and enhance overall comfort during and after radiation therapy.

Evolution of silicone therapy and mechanism of action in scar management.