RadiodermatitisRADIOCREMVALNCT05886673
Development of a Protective Cream Against Radiodermatitis Caused by Radiotherapy.
A study testing experimental cream in people with Radiodermatitis, run by Antonio J. Conde Moreno at 1 site in Spain.
Trial summary
The study cream is to be evaluated in a multicenter, randomized, controlled clinical study carried out in 2 hospitals, in the Radiation Oncology service of Valencia to evaluate its radioprotective and radiomitigation effect in the prophylactic treatment of acute radiodermatitis caused by radiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiodermatitis
- What is being tested?
- experimental cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSpain
- Study dates
- 29 Mar 2023to Dec 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
- Histologically confirmed localized (nonmetastatic) SCCHN.
- 18 years or older, with ECOG (Eastern Cooperative Oncology Group) Performance Status of performance from 0 to 2, a life expectancy of 6 months or more, and with signed informed consent.
- Intact skin at the start of radiotherapy.
Who cannot join
- Distant metastases, prior radiation therapy for SCCHN.
- Ongoing participation in any other study or clinical trial.
- Pregnant or lactating.
- Hypersensitivity to any of the components of the study cream.
- Prior or concurrent cancer within 5 years of study start and any other social or medical condition that may affect participation in or evaluation of the study will be excluded.
- History of collagen disease, such as systemic lupus erythematosus and/or scleroderma.
- Present dermatological conditions, such as psoriasis, bullous pemphigus or epidermolysis bullosa or bullosa.
- Inflammatory changes in the skin of the area to be irradiated.
Trial locations and contacts
1 site in 1 country.
About this study
The study cream is to be evaluated in a multicenter, randomized, controlled clinical study carried out in 2 hospitals, in the Radiation Oncology service of Valencia to evaluate its radioprotective and radiomitigation effect in the prophylactic treatment of acute radiodermatitis caused by radiation.
A total of 82 patients with squamous cell carcinoma of the head and neck (SCCHN) were are going to be randomized in a study. Patients receive the study topical cream or "standard" skin care from Hospitals where the study is carried out. All patients will be treated with a combination of fractionated radiotherapy and platinum-based chemotherapy OR cetuximab for curative purposes.
Read more
The main objective of the study cream is to obtain a reduction in the number of patients who experience acute radiation dermatitis grade 3 or 4 (NCI CTCAE version 4.03) to grade 2, the last day of treatment. As a secondary objective, to obtain a reduction in the number of patients experiencing grade 3 or 4 to grade 0 acute radiation dermatitis, within a month of finish treatment. All patients will be evaluated periodically. The skin is photographed irradiated and all changes of radiation dermatitis are classified. The valuation of the radiodermatitis will be carried out objectively using a thermograph. In addition, the patients who complete questionnaires about their quality of life (QLQ-C30). These Questionnaires are answered in weeks 1, 2, 3 and 4 of treatment, as well as at the end of the radiation therapy or chemotherapy.
For the primary endpoint of radiodermatitis with CTCAE ≥ grade 2, assessments are made according to the protocol (PP), in addition to the primary intention-to-treat (ITT) approach. In this PP analysis, the patients are excluded according to protocol definition or meeting decisions preanalysis, respectively. The study is designed as a randomized trial with a 1:1 allocation to the two groups.
The secondary objective is to study a reduction in the percentage of patients experiencing radiation dermatitis with a maximum CTCAE grade 3 or 4 during the period of treatment and in the follow-up period of one month, thanks to the application of the cream of study.
Read the detailed description
The study will be a randomized, controlled, parallel, prospective, double-blind, two-armed clinical study with a cosmeceutical product.
The creams (experimental cream (CE) and standard of care (SC)) will be randomly distributed among the patients, so that 50% receive CE and the other 50% SC. Each tube will have a number whose content does not neither the evaluators and the patients will know.
In a period between January 2023 and June 2023, the radiation oncology services of Hospitals La Fe and Clinic de Valencia conducted a study on 82 patients with SCCHN. what will they be undergoing external beam radiotherapy with or without concomitant chemotherapy.
Radiotherapy treatment uses techniques of modulated intensity of the radiation beam (IMRT or VMAT) image-guided (IGRT) that offer very high precision in the daily administration of treatment, improving the tolerance of healthy tissues and the quality life of patients.
Patients will be divided into two groups:
Group A (intervention, CE): this group will receive the topical application of the study cream.
Group B (control, SC): standard care will be applied to this group.
- Conditions
- Radiodermatitis
- Being tested
- experimental cream, standard of care
- Keywords
- radiodermatitis, oncology, radiotherapeutic oncology
- Medical subject headings
- Radiodermatitis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental creamOther
experimental cream
standard of careOther
standard of care
| Study group | Role | What they receive |
|---|---|---|
| Study treatment | Experimental | The experimental cream formulation has the same components as the control plus 2% pterostilbene, 1% silibinin and 2% nicotinamide riboside. Receives: Other: experimental cream |
| Control treatment | Other | The control cream formulation is designed to help maintaining skin hydration and texture. It contains common ingredients largely used in cosmetics: stearic acid, cetyl alcohol, liquid vaselin, isopropyl myristate, triethanolamine, methyl paraben, propyl paraben, propylene glycol, ethoxydiglycol, and water. Receives: Other: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction the occurrence of grade 2 radiodermatitis
Reduction (in the progression to severe radiation dermatitis) of the number of patients experiencing acute radiation dermatitis from grade 3 or 4 to grade 2 on the last day of treatment.
Measured: Through study completion, an average of 4 months
Delay in the occurrence of grade 2 radiodermatitis compared to the placebo group.
Delay in the occurrence of grade 2 radiodermatitis compared to the placebo group.
Measured: Through study completion, an average of 4 months
Secondary outcomes (1)
Incidence of radiodermatitis
To compare the percentage of patients (incidence) with radiodermatitis, the degree of toxicity and the percentage of cases with radiodermatitis grade 2 or higher in patients undergoing the different treatments, in the total sample and stratified by number of radiotherapy sessions per month and at the end of treatment.
To assess and compare the time to onset of each grade of skin reaction; to identify the frequency and location of specific features of radiodermatitis.
To study the health-related quality of life perceived by patients at the beginning and at the end of radiotherapy. of radiotherapy. To evaluate and compare the local symptoms described by patients during radiotherapy treatment and treatment and assessed by PREMS-PROMS.
To compare the temperature of the irradiated area using a thermograph during radiotherapy, in the 4 visits to be made by the patient. the 4 visits to be made by the patient.
Measured: through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start29 Mar 2023
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiodermatitisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antonio J. Conde Moreno
- Sponsor type
- University, hospital or other
- Collaborators
- University of Valencia
- Responsible party
- Sponsor-investigator, Antonio J. Conde Moreno, Instituto de Investigacion Sanitaria La Fe
- Investigators
- Antonio J Conde Moreno, Principal investigator, Medical Research Institut La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886673
- Sponsor's protocol ID
- 2022-963-1
- Acronym
- RADIOCREMVAL
- Status last verified
- Oct 2023
- First submitted
- 11 May 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Protective Cream Against Radiodermatitis Caused by Radiotherapy.
- ClinicalTrials.gov ID
- NCT05886673
- Acronym / sponsor ID
- RADIOCREMVAL / 2022-963-1
- Conditions
- Radiodermatitis
- Keywords
- radiodermatitis, oncology, radiotherapeutic oncology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Antonio J. Conde MorenoUniversity, hospital or other
- Collaborators
- University of Valencia
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 2 Jun 2023 (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.
The study cream is to be evaluated in a multicenter, randomized, controlled clinical study carried out in 2 hospitals, in the Radiation Oncology service of Valencia to evaluate its radioprotective and radiomitigation effect in the prophylactic treatment of acute radiodermatitis caused by radiation.
A total of 82 patients with squamous cell carcinoma of the head and neck (SCCHN) were are going to be randomized in a study. Patients receive the study topical cream or "standard" skin care from Hospitals where the study is carried out. All patients will be treated with a combination of fractionated radiotherapy and platinum-based chemotherapy OR cetuximab for curative purposes.
The main objective of the study cream is to obtain a reduction in the number of patients who experience acute radiation dermatitis grade 3 or 4 (NCI CTCAE version 4.03) to grade 2, the last day of treatment. As a secondary objective, to obtain a reduction in the number of patients experiencing grade 3 or 4 to grade 0 acute radiation dermatitis, within a month of finish treatment. All patients will be evaluated periodically. The skin is photographed irradiated and all changes of radiation dermatitis are classified. The valuation of the radiodermatitis will be carried out objectively using a thermograph. In addition, the patients who complete questionnaires about their quality of life (QLQ-C30). These Questionnaires are answered in weeks 1, 2, 3 and 4 of treatment, as well as at the end of the radiation therapy or chemotherapy.
For the primary endpoint of radiodermatitis with CTCAE ≥ grade 2, assessments are made according to the protocol (PP), in addition to the primary intention-to-treat (ITT) approach. In this PP analysis, the patients are excluded according to protocol definition or meeting decisions preanalysis, respectively. The study is designed as a randomized trial with a 1:1 allocation to the two groups.
The secondary objective is to study a reduction in the percentage of patients experiencing radiation dermatitis with a maximum CTCAE grade 3 or 4 during the period of treatment and in the follow-up period of one month, thanks to the application of the cream of study.
Detailed description
The study will be a randomized, controlled, parallel, prospective, double-blind, two-armed clinical study with a cosmeceutical product.
The creams (experimental cream (CE) and standard of care (SC)) will be randomly distributed among the patients, so that 50% receive CE and the other 50% SC. Each tube will have a number whose content does not neither the evaluators and the patients will know.
In a period between January 2023 and June 2023, the radiation oncology services of Hospitals La Fe and Clinic de Valencia conducted a study on 82 patients with SCCHN. what will they be undergoing external beam radiotherapy with or without concomitant chemotherapy.
Radiotherapy treatment uses techniques of modulated intensity of the radiation beam (IMRT or VMAT) image-guided (IGRT) that offer very high precision in the daily administration of treatment, improving the tolerance of healthy tissues and the quality life of patients.
Patients will be divided into two groups:
Group A (intervention, CE): this group will receive the topical application of the study cream.
Group B (control, SC): standard care will be applied to this group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study treatment | Experimental | Other: experimental creamThe experimental cream formulation has the same components as the control plus 2% pterostilbene, 1% silibinin and 2% nicotinamide riboside. |
| Control treatment | Other | Other: standard of careThe control cream formulation is designed to help maintaining skin hydration and texture. It contains common ingredients largely used in cosmetics: stearic acid, cetyl alcohol, liquid vaselin, isopropyl myristate, triethanolamine, methyl paraben, propyl paraben, propylene glycol, ethoxydiglycol, and water. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed localized (nonmetastatic) SCCHN.
- 18 years or older, with ECOG (Eastern Cooperative Oncology Group) Performance Status of performance from 0 to 2, a life expectancy of 6 months or more, and with signed informed consent.
- Intact skin at the start of radiotherapy.
Key exclusion criteria (8 listed)
- Distant metastases, prior radiation therapy for SCCHN.
- Ongoing participation in any other study or clinical trial.
- Pregnant or lactating.
- Hypersensitivity to any of the components of the study cream.
- Prior or concurrent cancer within 5 years of study start and any other social or medical condition that may affect participation in or evaluation of the study will be excluded.
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 |
|---|---|---|
| experimental creamexperimental cream | Other | Study treatment |
| standard of carestandard of care | Other | Control treatment |
Primary outcome
Reduction the occurrence of grade 2 radiodermatitis
Time frame: Through study completion, an average of 4 months
Reduction (in the progression to severe radiation dermatitis) of the number of patients experiencing acute radiation dermatitis from grade 3 or 4 to grade 2 on the last day of treatment.
Delay in the occurrence of grade 2 radiodermatitis compared to the placebo group.
Time frame: Through study completion, an average of 4 months
Delay in the occurrence of grade 2 radiodermatitis compared to the placebo group.
1 secondary outcome
Incidence of radiodermatitis
Time frame: through study completion, an average of 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 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.
Antonio J Conde Moreno principal investigator
Medical Research Institut La Fe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental cream in people with Radiodermatitis, run by Antonio J. Conde Moreno at 1 site in Spain.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio J Conde Moreno (+34 649 03 98 66, antoniojconde@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction the occurrence of grade 2 radiodermatitis (time frame: Through study completion, an average of 4 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 5 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.