← Back to Search

Topical Agent

StrataXRT vs Aquaphor for Radiation Dermatitis

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial is testing a new radiation therapy treatment for cancer in the groin area to see if it is more effective and has fewer side effects than the current standard of care.

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.Check my eligibility

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.See study design

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

Select...

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

Select...

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

Select...

I am 18 years old or older.

Select...

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

Select...

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of acute >grade 2 radiation dermatitis

Secondary outcome measures

Average toxicity assessed using the CTCAE

Itchiness score

Pain scores

+1 more

Side effects data

From 2010 Phase 4 trial • 39 Patients • NCT01093469

15%

upper respiratory infection

100%

80%

60%

40%

20%

Study treatment Arm

Atopiclair Nonsteroidal Cream

Aquaphor Healing Ointment

EpiCream Skin Barrier Emulsion

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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stratpharma AGLead Sponsor

10 Previous Clinical Trials

2,930 Total Patients Enrolled

Media Library

StrataXRT (Topical Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05553392 — N/A

Radiation Skin Damage Research Study Groups: StrataXRT, Aquaphor

Radiation Skin Damage Clinical Trial 2023: StrataXRT Highlights & Side Effects. Trial Name: NCT05553392 — N/A

StrataXRT (Topical Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05553392 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any fresh candidates receiving this clinical research at the present time?

"As indicated on clinicaltrials.gov, the recruitment period for this medical trial has ended. It was initially listed on December 1st 2022 and last edited on September 29th 2022. Currently, there are 225 active studies searching for patients to take part in their trials as an alternative option."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis

2022. "StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05553392.

All > Seborrheic Dermatitis > Eczema