A study to investigate the degree to which a new product, RB Lotion, is safe, well tolerated and acceptable for treating Radiation Induced Skin Reactions (RISR) in subjects being treated with external beam radiotherapy, compared with their usual care.
- Conditions
- Radiation Induced Skin Reactions (RISR)MedDRA version: 20.0 Level: LLT Classification code 10061103 Term: Dermatitis radiation System Organ Class: 100000004863Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2015-002258-10-GB
- Lead Sponsor
- Dermal Laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
• Male or Female subjects =18 years;
• Understand and voluntarily sign informed consent form prior to any study related assessments/procedures being conducted;
• Scheduled to receive palliative external beam RT;
• Treatment areas including only the thorax or limbs;
• Anticipated treatment field is at least 8 cm in the superior/inferior and
medial/lateral directions;
• The planned total radiation dose does not exceed a planned prescribed dose of 20 Gy (prescribed for the mid-planar point) or a DMax of 30 Gy in no more than 5 Fractions of RT over no more than a 10 day period, using 6-10 MV photons (and a tissue equivalent bolus material is not used);
• The subject or a carer must be able to administer the topical products to the treatment area;
• The subject needs to have an anticipated life expectancy of greater than 3 months from date of randomisation;
•The subject must be willing to abstain from the use of NSAIDs (systemic and topical other than Ibuprofen in study product or oral Aspirin up to a maximum daily dose of 75mg) from 72 hours prior to randomisation until at least Visit 7 or until the skin at the treatment site is assessed to be RTOG 0 on both sides if this is not confirmed at Visit 7. The restriction on the use of topical NSAIDS on or near the treatment site (as determined by the investigator) remains throughout the study;
•The subject must be willing to abstain from the use of topical corticosteroids, on or near the treatment site (as determined by the investigator) from 72 hours prior to randomisation until the end of the study unless an assessment of RTOG 2A or 2B is confirmed (when specific local standard care corticosteroid treatment is permitted as per Section 7.7);
• The subject must be willing to abstain from using emollients or moisturisers with the exception of study product, on or near the treatment site (as determined by the investigator) during the study.
• The subject must be willing and able to comply with the study instructions and the study medication as directed and attend all scheduled visits;
• Treatment area should not have any obvious breaks or lacerations in skin and should not be in an area of significant curvature of the skin surface (e.g. groin area) as assessed by the Investigator;
• A score of RTOG 0 confirmed at the proposed treatment field;
• Female subjects must have a negative urine pregnancy test at visit 1 unless they are surgically sterile or have been post menopausal for = 1 year (12 consecutive months without menses).
• Female subjects of childbearing potential must be using a highly effective and medically acceptable means of birth control and agree to continue its use for the duration of the study.
A highly effective and medically acceptable method of birth control is defined as any form of contraception with a low failure rate defined as < 1% per year and for this study include;
- combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal and transdermal) associated with inhibition of ovulation.
- progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation
- intrauteri
• Concurrent participation in another interventional clinical study, or participation within 30 days before Visit 1 of this study;
• Subjects who have active dermatitis involving the treatment area;
• Patients with known radiation sensitivity syndromes e.g. Ataxia telangiectasia, Fanconi’s Anaemia, etc;
• Subjects who have used systemic or topical NSAIDs other than oral Aspirin (maximum daily dose of 75mg) within the 72 hours prior to randomisation;
•Subjects who have used topical corticosteroids on or near the treatment site (as determined by the investigator) within the 72 hours prior to randomisation;
• Subjects who have atrophy of the skin involving the treatment area;
• Subjects who have signs of ongoing bacterial, viral or fungal infection of the skin involving the treatment area;
• Subjects who have undergone RT within the previous 6 weeks or are receiving concurrent chemotherapy;
• The current treatment field is within 2cm of a previous treatment field;
• Presence of skin involvement by tumour;
• Subjects who have previously had a radiation-related skin reaction greater than RTOG 2A;
• The anticipated life expectancy is less than 3 months;
• An ECOG performance status score of 4;
• If the subject is pregnant or lactating;
• If the subject has a clinically relevant history of hypersensitivity, allergy or contraindications to ibuprofen or any of the excipients of RB Lotion or Diprobase Cream. This includes known sensitivity to aspirin or other NSAID painkillers (including when taken by mouth), especially where associated with a history of asthma, rhinitis, urticaria, an active peptic ulcer or a history of kidney problems.
• Those who in the opinion of the Investigator are unsuitable for participation in the study or exhibit other factors limiting their ability to co-operate and to comply with the protocol;
• Employees of the Investigator, trial site, CRO, or sponsor, as well as family members of the employees or the Investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method