An interventional study of StrataXRT and Aquaphor in Radiation Dermatitis, sponsored by Stratpharma AG. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-04.
Sponsored by Stratpharma AG · Not applicable, Interventional, and Prevention
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.
127 studies on the registry are indexed under Radiodermatitis; 26 are open to participants now.
This study's enrollment of 13 is below the median of 55 across 104 interventional studies indexed under Radiodermatitis.
Browse Radiodermatitis studies →Stratpharma AG is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: Until 8 weeks post radiation therapy; up to 4 months
Average toxicity assessed using the CTCAE
The Common Terminology Criteria for Adverse Events (CTCAE- Version 5.0) will be used to assess the severity of RD. Patients will be assessed in a repeated measurement model following the visits calendar. The assessments will be pooled based on their visit week and cumulative dose. The repeated measurements average toxicity will be compared in both study groups.
Time frame: Until 8 weeks post radiation therapy; up to 4 months
Time to onset of moist desquamation
The Common Terminology Criteria for Adverse Events (CTCAE- Version 5.0) will be used to assess the severity of RD.Patients will be assessed in a repeated measurement model following the visits calendar. The assessments will be pooled based on their visit week and cumulative dose. The time to moist desquamation will be compared in both study groups.
Time frame: Until 8 weeks post radiation therapy; up to 4 months
Pain scores
The participant will be asked to rate their pain level at the irradiated area. The time of interest of the original VAS is modified from "the past 24 hours" to "the past 7 days" for the specific purpose of this study. The VAS has been selected as it is a brief and easy tool for the assessment of pain within both the clinical and research settings. It has been well validated in both the chronic pain and cancer settings. The scale of 0 to 10 is simple for patients to use and reflects common clinical assessment of pain. Patients will be assessed in a repeated measurement model following the visits calendar. The assessments will be pooled based on their visit week and cumulative dose. The average pain will be compared in both study groups. The worst pain will be compared in both study groups. Pain relief will be measured in the repeated measurements analysis.
Time frame: Until 8 weeks post radiation therapy; up to 4 months
Itchiness score
Itching will be scored on a numeric analogue scale of 0-10 in the treated skin (0= no itching at all), (10= itching as bad as you can imagine). Patients will be assessed in a repeated measurement model following the visits calendar. The assessments will be pooled based on their visit week and cumulative dose. The average pain will be compared in both study groups. The worst pain will be compared in both study groups. Pain relief will be measured in the repeated measurements analysis.
Time frame: Until 8 weeks post radiation therapy; up to 4 months
Plan to share: No
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Ran from Nov 2022 to primary completion in May 2024, 18 months.
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This study is terminated, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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