Radiation DermatitisNCT05450848
StrataXRT vs. Standard Clinical Practice in the Prevention and Treatment of Radiation Dermatitis
A study testing StrataXRT and Sorbolene in people with Radiation Dermatitis, run by Stratpharma AG at 2 sites in Australia.
Trial summary
Current clinical practice for preventing and treating radiation dermatitis across Queensland (QLD) Health Radiation Oncology departments involves the application of aqueous cream daily to the skin of the treatment site, commencing from Day 1 of EBRT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Dermatitis
- What is being tested?
- StrataXRT and Sorbolene
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesAustralia
- Study dates
- 1 Sep 2017to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with cancer undergoing a curative course of radiation therapy using standard protocols to the following cancer sites:
- Head and neck cancers receiving >= 60Gy who are not receiving concurrent Cetuximab
- Intact breast receiving >= 40Gy (includes patients receiving boost fields using photon or elections)
- Post-mastectomy chest wall (breast cancer diagnosis only) receiving >= 50Gy
- Gynaecological cancers requiring whole pelvis irradiation receiving >= 45Gy
- Skin cancers to the axilla/groin regions receiving >= 40Gy
Show all 9Show fewer
- Male and female patients >18 years of age
- Patients who do not have a known allergy to silicon
- Patients who are able to attend the four post-treatment weekly skin assessment appointments
Who cannot join
- Ineligible participants are patients undergoing a course of curative radiation therapy:
- Who are participating in another interventional study
- With an allergy to product content (standard or StrataXRT)
- With an existing skin rash, ulceration or open wound in the treatment area
- With a pre-existing systemic skin disease (dermatological conditions, connective tissue disorders)
- Who have had previous radiation therapy to the current treatment area
- Who are on immuno-suppression drugs
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Townsville Cancer Center, Townsville Hospital and Health Service
Douglas, Queensland, 4814
Princess Alexandra Hospital
South Brisbane, Queensland, 4101
About this study
Official title: A Randomised Comparison of StrataXRT to Standard Clinical Practice in the Prevention and Treatment of Radiation Dermatitis
Current clinical practice for preventing and treating radiation dermatitis across Queensland (QLD) Health Radiation Oncology departments involves the application of aqueous cream daily to the skin of the treatment site, commencing from Day 1 of EBRT. The primary aim of this study is to assess the efficacy of StrataXRT when compared to current clinical practice in preventing and managing radiation dermatitis.
- Conditions
- Radiation Dermatitis
- Being tested
- StrataXRT, Sorbolene
- Medical subject headings
- Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StrataXRTDevice
StrataXRT is a flexible wound dressing for the prevention and treatment of radiation dermatitis. It is in the form of a gel which, when applied, creates a protective film that maintains skin integrity. The product is used to relieve low grade inflammatory radiation changes such as dry, itching, flaking, peeling and irritated skin. For more severe inflammatory changes with open wound components, StrataXRT reduces pain, redness and heat and helps soothe the exposed skin areas. StrataXRT can be applied where skin integrity has been compromised and may also be used in conjunction with other adjunctive treatments to improve overall results. StrataXRT contains Polydimethylsiloxanes, Siloxanes and Alkylmethyl Silicones and is transparent and odourless. It does not contain alcohols, parabens or fragrances. StrataXRT can be used with or without a secondary protective dressing. It is suitable for children and people with sensitive skin.
SorboleneOther
Aqueous cream (moisturizer) that soothes itchiness and dryness of the skin, and aids skin hydration. It is non-greasy, fragrance free, colour free, GMO free, paraben free and pH balanced.
| Study group | Role | What they receive |
|---|---|---|
| StrataXRT | Experimental | Patients allocated to receive StrataXRT will be provided with StrataXRT gel to apply twice daily to the irradiated area until any radiation dermatitis that may occur has resolved. In case the patient develops radiation dermatitis that results in moist desquamation, IntraSiteTM gel (Smith and Nephew, UK) and secondary dressings will be provided. Receives: Device: StrataXRT |
| Standard of care | Active comparator | Patients allocated to receive standard care will be provided with aqueous cream to apply daily to the irradiated area until any radiation dermatitis that may occur has resolved. In case the patient develops radiation dermatitis that results in moist desquamation, IntraSiteTM gel (Smith and Nephew, UK) and secondary dressings will be provided. Receives: Other: Sorbolene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Radiation dermatitis reaction as assessed by blinded assessment of digital photographs using the CTCAE v4.0 radiation dermatitis grades. CTCAE v4.0 severity grades are categorical with 5 possible categories (1, 2, 3, 4, 5). Grade 1 represents the weakest form of radiation dermatitis. Higher CTCAE Grades represent increasing radiation dermatitis severity.
Measured: From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
Radiation induced skin reaction assessment scale (RISRAS)
Radiation dermatitis reaction as assessed by the clinician during patient consultations using the eviQ RISRAS form. RISRAS scale is continuous scale from 0 to 36, with higher RISRAS scores representing higher severity of radiation dermatitis.
Measured: From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
Secondary outcomes (5)
Onset of radiation dermatitis
Timepoint of onset of CTCAE v4.0 radiation dermatitis Grades 2 and/or 3 during or after radiotherapy.
Measured: From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
Length of time until resolution of radiation dermatitis
Length of time from peak incidence to resolution of radiation dermatitis.
Measured: From onset of radiation dermatitis, until radiation dermatitis resolution, up to 3 months
Patient reported symptoms treatment
Patient reported comfort scale obtained using the eviQ RISRAS form.
Measured: From onset of radiation dermatitis, until radiation dermatitis resolution, up to 3 months
Cost-effectiveness
The mean total cost of skin care per patient.
Measured: From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
Incidence of late-effects skin toxicity
The late skin toxicity post-radiotherapy assessed using the Radiation Therapy Oncology Group (RTOG) grading definitions:
Grade 0: No change over baseline Grade I: Follicular, faint or dull erythema, epilation, dry desquamation, decreased sweating Grade II: Tender or bright erythema, patchy moist desquamation, moderate oedema Grade III: Confluent, moist desquamation other than skin folds, pitting oedema Grade IV: Ulceration haemorrhage, necrosis
Measured: 3 - 12 months post radiation treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start1 Sep 2017
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stratpharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450848
- Sponsor's protocol ID
- SPASX01AU002
- Status last verified
- Jul 2023
- First submitted
- 22 Jun 2022
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Comparison of StrataXRT to Standard Clinical Practice in the Prevention and Treatment of Radiation Dermatitis
- ClinicalTrials.gov ID
- NCT05450848
- Acronym / sponsor ID
- SPASX01AU002
- Conditions
- Radiation Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Stratpharma AGIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Current clinical practice for preventing and treating radiation dermatitis across Queensland (QLD) Health Radiation Oncology departments involves the application of aqueous cream daily to the skin of the treatment site, commencing from Day 1 of EBRT. The primary aim of this study is to assess the efficacy of StrataXRT when compared to current clinical practice in preventing and managing radiation dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| StrataXRT | Experimental | Device: StrataXRTPatients allocated to receive StrataXRT will be provided with StrataXRT gel to apply twice daily to the irradiated area until any radiation dermatitis that may occur has resolved. In case the patient develops radiation dermatitis that results in moist desquamation, IntraSiteTM gel (Smith and Nephew, UK) and secondary dressings will be provided. |
| Standard of care | Active comparator | Other: SorbolenePatients allocated to receive standard care will be provided with aqueous cream to apply daily to the irradiated area until any radiation dermatitis that may occur has resolved. In case the patient develops radiation dermatitis that results in moist desquamation, IntraSiteTM gel (Smith and Nephew, UK) and secondary dressings will be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with cancer undergoing a curative course of radiation therapy using standard protocols to the following cancer sites:
- Male and female patients >18 years of age
- Patients who do not have a known allergy to silicon
- Patients who are able to attend the four post-treatment weekly skin assessment appointments
Key exclusion criteria (7 listed)
- Who are participating in another interventional study
- With an allergy to product content (standard or StrataXRT)
- With an existing skin rash, ulceration or open wound in the treatment area
- With a pre-existing systemic skin disease (dermatological conditions, connective tissue disorders)
- Who have had previous radiation therapy to the current treatment area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StrataXRTStrataXRT is a flexible wound dressing for the prevention and treatment of radiation dermatitis. It is in the form of a gel which, when applied, creates a protective film that maintains skin integrity. The product is used to relieve low grade inflammatory radiation changes such as dry, itching, flaking, peeling and irritated skin. For more severe inflammatory changes with open wound components, StrataXRT reduces pain, redness and heat and helps soothe the exposed skin areas. StrataXRT can be applied where skin integrity has been compromised and may also be used in conjunction with other adjunctive treatments to improve overall results. StrataXRT contains Polydimethylsiloxanes, Siloxanes and Alkylmethyl Silicones and is transparent and odourless. It does not contain alcohols, parabens or fragrances. StrataXRT can be used with or without a secondary protective dressing. It is suitable for children and people with sensitive skin. | Device | StrataXRT |
| SorboleneAqueous cream (moisturizer) that soothes itchiness and dryness of the skin, and aids skin hydration. It is non-greasy, fragrance free, colour free, GMO free, paraben free and pH balanced. | Other | Standard of care |
Primary outcome
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
Radiation dermatitis reaction as assessed by blinded assessment of digital photographs using the CTCAE v4.0 radiation dermatitis grades. CTCAE v4.0 severity grades are categorical with 5 possible categories (1, 2, 3, 4, 5). Grade 1 represents the weakest form of radiation dermatitis. Higher CTCAE Grades represent increasing radiation dermatitis severity.
Radiation induced skin reaction assessment scale (RISRAS)
Time frame: From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
Radiation dermatitis reaction as assessed by the clinician during patient consultations using the eviQ RISRAS form. RISRAS scale is continuous scale from 0 to 36, with higher RISRAS scores representing higher severity of radiation dermatitis.
5 secondary outcomes
Onset of radiation dermatitis
Time frame: From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
Length of time until resolution of radiation dermatitis
Time frame: From onset of radiation dermatitis, until radiation dermatitis resolution, up to 3 months
Patient reported symptoms treatment
Time frame: From onset of radiation dermatitis, until radiation dermatitis resolution, up to 3 months
Cost-effectiveness
Time frame: From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
Incidence of late-effects skin toxicity
Time frame: 3 - 12 months post radiation treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StrataXRT and Sorbolene in people with Radiation Dermatitis, run by Stratpharma AG at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Common Terminology Criteria for Adverse Events (CTCAE) v4.0 (time frame: From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.