Early Radiation DermatitisPhase 4NCT02495064
Mometasone Furoate Cream Reduces Acute Radiation Dermatitis in Head and Neck Squamous Cell Carcinomas' Patients
A Phase 4 study testing Mometasone Furoate Cream in people with Early Radiation Dermatitis, run by Yao Liao at 1 site in China.
Trial summary
Radiation dermatitis is an acute effect of radiation therapy,Especially in the neck skin of head and neck squamous cell carcinomas' patients.The investigators wanted to confirm the benefit of mometasone furoate (MF) in preventing acute radiation reactions, as shown in a previous study. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Early Radiation Dermatitis
- What is being tested?
- Mometasone Furoate Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2016
- Phase
- Phase 4
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- pathological diagnosis for head and neck squamous cell carcinomas and
- going to have radiotherapy.
Who cannot join
- pregnant,
- lactating women,
- infants,
- elderly people with atrophy skin,
- allergic constitution patients,
- the corresponding parts of 5 radiotherapy skin ulceration or infection and
- allergic patients to Mometasone Furoate Cream.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
oncology department of Mian yang central Hosptial
Mianyang, Sichuan, 0816
Liao Yao, Resident, 0086-13778106466, 425838503@qq.com
Du x bo, Chief, 0086-13550822229, duxiaobo2005@126.com
About this study
Official title: Mometasone Furoate Cream Reduces Acute Radiation Dermatitis in Head and Neck Squamous Cell Carcinomas' Patients Receiving Radiation Therapy
Radiation dermatitis is an acute effect of radiation therapy,Especially in the neck skin of head and neck squamous cell carcinomas' patients.The investigators wanted to confirm the benefit of mometasone furoate (MF) in preventing acute radiation reactions, as shown in a previous study.
Read the detailed description
A randomized,self-comparative controlled trial was undertaken comparing MF cream with no cream administered from the first day of treatment for 5-6 weeks to prevent radiation dermatitis of neck during radiation therapy to the head and neck squamous cell carcinomas' Patients.
One side of patients' neck will begin to use MF cream from the first day of radiation therapy, while the other side accept no preventive measures.
- Conditions
- Early Radiation Dermatitis
- Being tested
- Mometasone Furoate Cream
- Medical subject headings
- Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mometasone Furoate CreamDrug
Also called Eloson
One side of patients' neck will begain to use MF cream from the first day of radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Mometasone Furoate Cream(MF) | Experimental | participants will be given conventional Chemoradiotherapy and MF.
MF Brief introduction:
Generic name :Mometasone Furoate Cream. Dosage form:Each gram of Mometasone Furoate Cream contains mometasone furoate, USP in a cream base of hexylene glycol, phosphoric acid, propylene glycol stearate, stearyl alcohol and ceteareth-20, titanium dioxide, aluminum starch octenylsuccinate, white wax, white petrolatum, and purified water.
Dosage:Apply a thin film of Mometasone Furoate Cream to the affected skin areas once daily during radiotherapy.
It is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Receives: Drug: Mometasone Furoate Cream |
| Chemoradiotherapy | No intervention | conventional Chemoradiotherapy only |
What is being measured
The primary outcome is the main question the study is designed to answer.
the mean Radiation Therapy Oncology Group (RTOG) skin dermatitis score
The investigators descriph the skin dermatitis scores every week during radiation therapy and the later two weeks as follows:The scores were 0 = no visible change; 1 = faint or dull erythema; 2 = tender or bright erythema with or without moist desquamation; 3 = patchy moist desquamation with moderate edema; and 4= confluent moist desquamation with pitting edema.
Measured: seven weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yao Liao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yao Liao, Mianyang Central Hospital
- Investigators
- Wang dong, Principal investigator, Health Bureau of Mian Yang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495064
- Sponsor's protocol ID
- MianyangCH
- Status last verified
- Mar 2016
- First submitted
- 25 Jan 2015
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mometasone Furoate Cream Reduces Acute Radiation Dermatitis in Head and Neck Squamous Cell Carcinomas' Patients Receiving Radiation Therapy
- ClinicalTrials.gov ID
- NCT02495064
- Acronym / sponsor ID
- MianyangCH
- Conditions
- Early Radiation Dermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Yao LiaoUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 13 Jul 2015 (estimated)
- 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.
Radiation dermatitis is an acute effect of radiation therapy,Especially in the neck skin of head and neck squamous cell carcinomas' patients.The investigators wanted to confirm the benefit of mometasone furoate (MF) in preventing acute radiation reactions, as shown in a previous study.
Detailed description
A randomized,self-comparative controlled trial was undertaken comparing MF cream with no cream administered from the first day of treatment for 5-6 weeks to prevent radiation dermatitis of neck during radiation therapy to the head and neck squamous cell carcinomas' Patients.
One side of patients' neck will begin to use MF cream from the first day of radiation therapy, while the other side accept no preventive measures.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mometasone Furoate Cream(MF) | Experimental | Drug: Mometasone Furoate Creamparticipants will be given conventional Chemoradiotherapy and MF. MF Brief introduction: Generic name :Mometasone Furoate Cream. Dosage form:Each gram of Mometasone Furoate Cream contains mometasone furoate, USP in a cream base of hexylene glycol, phosphoric acid, propylene glycol stearate, stearyl alcohol and ceteareth-20, titanium dioxide, aluminum starch octenylsuccinate, white wax, white petrolatum, and purified water. Dosage:Apply a thin film of Mometasone Furoate Cream to the affected skin areas once daily during radiotherapy. It is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. |
| Chemoradiotherapy | No intervention | –conventional Chemoradiotherapy only |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- pathological diagnosis for head and neck squamous cell carcinomas and
- going to have radiotherapy.
Key exclusion criteria (7 listed)
- pregnant,
- lactating women,
- infants,
- elderly people with atrophy skin,
- allergic constitution patients,
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 |
|---|---|---|
| Mometasone Furoate CreamAlso: ElosonOne side of patients' neck will begain to use MF cream from the first day of radiation therapy. | Drug | Mometasone Furoate Cream(MF) |
Primary outcome
the mean Radiation Therapy Oncology Group (RTOG) skin dermatitis score
Time frame: seven weeks
The investigators descriph the skin dermatitis scores every week during radiation therapy and the later two weeks as follows:The scores were 0 = no visible change; 1 = faint or dull erythema; 2 = tender or bright erythema with or without moist desquamation; 3 = patchy moist desquamation with moderate edema; and 4= confluent moist desquamation with pitting edema.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
Related trials for Early Radiation Dermatitis
RecruitingPhase 2
Superoxide Dismutase Skin Spray for the Prevention of Acute Radiation Dermatitis in Head and Neck Cancer
Radiation-induced Dermatitis
RecruitingEarly Phase 1
Adapalene Gel for Acute Radiation-Induced Skin Injury
Radiation Dermatitis
RecruitingPhase 1
Using Silverlon® for Head and Neck Patients With Tracheostomies
Head and Neck Cancer, Radiation Dermatitis Acute
Enrolling by invitationPhase 3
Oral or Topical Catechins for Radiation Dermatitis
Radiation Dermatitis Acute, Radiation Dermatitis
RecruitingPhase 1
Akkermansia Muciniphila (AKK) for Radiation-Induced Skin Injury
Radiation-Induced Skin Injury
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.
Wang dong principal investigator
Health Bureau of Mian Yang
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mometasone Furoate Cream in people with Early Radiation Dermatitis, run by Yao Liao at 1 site in China.
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 2 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: status not confirmed, as of the sponsor's last update on 9 Mar 2016. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Liao Yao (0086-13778106466, 425838503@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the mean Radiation Therapy Oncology Group (RTOG) skin dermatitis score (time frame: seven weeks). 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 9 Mar 2016.