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Radiation Dermatitis clinical trials

View clinical trials related to Radiation Dermatitis.

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NCT ID: NCT04593914 Withdrawn - Clinical trials for Head and Neck Cancer

A Novel Skin Barrier Protectant for Acute Radiodermatitis

CASP-ORL
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Acute radiodermatitis (ARD) is a distressing and painful skin reaction that occurs in 95% of the patients undergoing radiotherapy (RT). To date, there is still no general approved guideline for the prevention and management of acute radiodermatitis. The 3M™ Cavilon™ Advanced Skin Protectant is a novel skin barrier protectant that acts as a physical barrier against abrasion, moisture, and irritants. Moreover, it enables an environment for wound healing. The aim of this study is to evaluate the effectiveness of 3M™ Cavilon™ Advanced Skin Protectant in the prevention and management of ARD in patients with head and neck cancer.

NCT ID: NCT04560803 Recruiting - Clinical trials for Radiation Dermatitis

Epidermal Skin Grafts to Improve Healing In Radiation Wounds

Start date: January 19, 2021
Phase: N/A
Study type: Interventional

Patients undergoing radiation for the treatment of malignancies may suffer from side effects to the skin in the form of radiation dermatitis. This can lead to local wound formation with poor healing. Treatment options for the resulting wound can range from watchful waiting to more aggressive debridement and secondary grafting. Epidermal grafting is a technique in which autologous epidermis is used to cover wounds that are larger than the donor site. Previous studies have demonstrated that this is an effective treatment for different wounds and ulcers but its utility has not yet been evaluated for the treatment of radiation induced injuries. The CelluTome Epidermal Grafting System is a semi automated device that allows easy formation of epidermal Blister. Our study will evaluate the efficacy of epidermal grafts collected using the CelluTome device in the treatment of radiation dermatitis.

NCT ID: NCT04481802 Recruiting - Breast Cancer Clinical Trials

The Effect of RadiaAce Gel in the Prevention and Treatment of Radiation Dermatitis in Breast Cancer Patients

Start date: July 14, 2021
Phase: N/A
Study type: Interventional

Radiation dermatitis (RD) is one of the most common side effects of Radiation therapy (RT) and 95% of patients receiving RT may experience some form of radiation dermatitis. A wide variety of topical, oral, and intravenous agents are used to prevent/treat Radiation dermatitis but currently there is no gold standard in the prevention and management of this condition and no treatment can be explicitly recommended. RadiaAce Gel is a wound dressing Hydrogel (Acemannan Hydrogel) for the management of RD which provides optimal moist wound environment necessary to the healing process. Based on its composition as well as the supporting data on safety and performance of the functional ingredient Acemannan in wound healing, RadiaAce may well be suited to complement the prevention and therapy of radiation dermatitis. The primary aim of the study is to evaluate the safety and performance of RadiaAce as compare to Biafine in reducing the proportion of breast cancer patients that experience grade 2 or higher RD as measured by the RTOG scoring system

NCT ID: NCT04300829 Recruiting - Radiation Toxicity Clinical Trials

Cicaderma Efficacy vs Standard Care of Sites in Preventing Radiodermatitis in Non-metastatic Breast Cancer Patients

CICA-RT
Start date: June 6, 2020
Phase: Phase 3
Study type: Interventional

Phase III, prospective, interventional, multicentric, comparative, randomized, open study with 2 parallel arms, evaluating the efficacy of Cicaderma ointment vs standard management of each site in preventing the onset of grade > 2 radiodermatitis according to the National Cancer Institute - Common Terminology Criteria for Adverse Events-Version (NCI-CTCAE-V5)

NCT ID: NCT04268056 Active, not recruiting - Clinical trials for Radiation Dermatitis

Characterization of Skin Microbiome Profile and it's Correlation to Radiation Dermatitis

Start date: November 1, 2020
Phase:
Study type: Observational

The purpose of this study is to characterize the skin microbiome profile of breast cancer patients before and after receiving Radio Therapy treatments, and evaluate the relationship between the microbiome profile and radiation dermatitis severity (grade) that the patient will develop. Such characterizations can lead to potential biomarkers and/or therapeutic targets that can be used for the prognosis, prevention and treatment of this condition.

NCT ID: NCT04261387 Completed - Clinical trials for Radiation Dermatitis

LUT014 for the Treatment of Radiation Induced Dermatitis in Breast Cancer Patients

Start date: January 30, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The study will evaluate the safety, tolerability and efficacy of LUT014 gel topically administered in breast cancer patients who developed radiation dermatitis. Subjects enrolled to part 1 will be enrolled to receive the study treatment (open label treatment) for 28 days and will be followed up for 2 months after the completion of study treatment. Subject in Part 2 will be randomized in 1:1 ratio to receive either the study drug or placebo (double-blind treatment) for qd topical application for 28 days and will be followed up for 2 months after the completion of study treatment.

NCT ID: NCT04238728 Completed - Clinical trials for Radiation Dermatitis

Silverlon to Reduce Radiation Dermatitis

Start date: August 31, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to see if a silver-nylon dressing (Silverlon®, Argentum Medical) is useful for the prevention or treatment of radiation dermatitis in patients receiving radiation therapy to the breast.

NCT ID: NCT04173247 Completed - Clinical trials for Head and Neck Cancer

Study of KeraStat Cream for Radiation Dermatitis During Head and Neck Radiotherapy

Start date: July 27, 2020
Phase: N/A
Study type: Interventional

This is a single site, randomized, open-label comparison pilot study to assess the feasibility and effectiveness of KeraStat Cream compared with routine skin care (RSC) in managing radiotherapy-induced early adverse skin reaction (EASR) in patients undergoing radiotherapy to the head and/or neck. Hypothesis: The use of KeraStat Cream in patients receiving radiotherapy for head and neck is feasible, tolerable, and reduces the severity of early adverse skin reaction in the treated region of interest.

NCT ID: NCT04166799 Active, not recruiting - Breast Cancer Clinical Trials

Randomized Phase III Trial With Mepitel Film for the Prophylaxis of Radiation Dermatitis in Breast Cancer Patients

Start date: January 30, 2020
Phase: N/A
Study type: Interventional

Breast cancer patients undergoing adjuvant radiotherapy commonly experience radiation-induced skin reactions which adversely impact quality of life. Importantly, patients receiving chest wall radiation or patients with large breasts are more likely to have worse skin reactions. In the last decade, there have been no significant advances in preventing or treating radiation-induced skin toxicities. In response to the lack of evidence, Sunnybrook investigators previously conducted a pilot study (REB #294-2018) of Mepitel Film and preliminary results showed improvements in high grade skin reactions. Mepitel Film has not been widely adopted in North America as more evidence is needed. The validate the efficacy of the film compared to the standard of care, a study testing the efficacy of the film is proposed. In the study, 216 patients will be randomized (2:1) to receive either the film or the institution's current skin treatments and all patients will have their skin assessed.

NCT ID: NCT04149522 Terminated - Breast Cancer Clinical Trials

Evaluation of Mepitel Film® in Preventing Epidermitis in Patients Receiving Radiation Therapy for Breast Cancer

Start date: January 15, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this research is to evaluate the use of Mepitel Film® in preventing radiation epidermitis in patients receiving radiation treatment for breast cancer. Mepitel® Film is a thin, flexible, waterproof, and breathable film made of a soft silicone layer and polyurethane film. Mepitel ® film is not made with natural rubber latex (NRL). It is FDA approved for the management of superficial wounds, such as superficial burns. As a part of this research study, the Mepitel Film® will be placed prior to participant's first radiation treatment, and will be removed one week following the end of treatment. Throughout the study, information will be collected to analyze at the end of the research study to determine if the Mepitel Film® helps prevent skin breakdown. The subjects will be followed per standard of care and examined for skin redness, warmth or swelling as normally examined and cared for during standard radiation therapy. If radiation burns are noted, the subject will be treated normally and depending on the severity of the radiation burns, may be removed from the study treatment and treated through standard of care.