Latest news about KeraStat® Cream:
Our 1 oz. tubes, available by prescription only, contain human-derived keratin proteins for the management of radiation dermatitis. Patients can benefit by applying KeraStat® Cream after receiving their first dose of radiation. Our product is especially useful for patients receiving radiotherapy for head, neck, throat, chest wall, skin, and breast cancers.
ASPN Pharmacies Becomes the Primary Distributor of KeraStat®, the leading prescription product for managing Radiation Dermatitis
Winston-Salem, N.C., February 6, 2023 – KeraNetics Inc. announced today that prescriptions for KeraStat® Cream for the management of Radiation Dermatitis can now be written through electronic medical record systems such as Epic and will be processed and fulfilled through ASPN Pharmacies. ASPN is a nationwide online pharmacy offering a streamlined prescription process for patients and providers utilizing at-home or pharmacy–of–their–choice delivery.
In addition to providing product access to the patient, ASPN Pharmacies support for KeraStat® Cream also includes:
- Benefit Investigations for Pharmacy and Medical Claims
- Dedicated KeraStat® Care Team for Streamlined Support
- Prior Authorization Support
- Appeal and Triage Support
- Support Team Hours 8:30AM to 5:00PM Eastern Time
According to a statement by Dr. Luke Burnett, CEO and Chief Science Officer, “KeraNetics is excited to announce that KeraStat® Cream will be distributed by ASPN Pharmacies. KeraStat® Cream is cleared by the FDA for use by cancer patients all over the US for radiation dermatitis. We are excited that clinicians can now prescribe KeraStat® Cream before their patients’ first radiotherapy treatment. This will increase patient quality of life, particularly for those receiving radiotherapy for head, neck, throat, skin, and breast cancers.”
After healthcare providers order a prescription through E-Prescribe using Epic (or similar), ASPN Pharmacies will reach out directly to patients to obtain shipping, coverage, and payment information. Patients can also contact ASPN Pharmacies by calling 1-888-865-1021. ASPN Pharmacies will deliver KeraStat® Cream directly to patients or their pharmacy of choice.
Access KeraStat® Cream prescriber instruction sheets and patient prescription handout HERE
KeraStat® Cream is intended to maintain a moist wound environment. KeraStat® Cream is indicated for the management of a number of partial thickness skin wounds such as partial thickness (first and second degree) burns, severe sunburns, superficial injuries, cuts, abrasions, and incisions/surgical wounds. Under the direction of a healthcare professional, KeraStat® Cream also may be used in the management of dry, light, and moderately exuding partial thickness wounds including pressure (stage I-II) ulcers, venous stasis ulcers, ulcers caused by mixed vascular etiologies, diabetic ulcers, radiation dermatitis, donor sites, and grafts. Please refer to the KeraStat® Cream package insert or visit www.keranetics.com/CreamPackageInsert for a downloadable version of the device package insert.
KeraStat® Cream is not indicated for full thickness (third degree) burns. This device is only available by prescription.
KeraStat® is a registered trademark of KeraNetics™, Inc., in the United States and/or other countries. All rights reserved.
KeraStat® Cream is currently available to patients as an FDA-cleared cream for dermatitis after receiving radiotherapy.
It is one of the only Rx products currently available in the US market specifically indicated for Radiation Dermatitis.
The FDA approval process for medical devices is determined by risk classification. KeraStat® Cream received pre-market clearance as an “Unclassified” topical cream product. Under the FDA 510(k) medical device regulatory pathway, the product underwent a review process resulting in a “Cleared” designation. This assessment, like drug approvals in scope, involves a full panel review by the FDA.
This device, KeraStat® Cream, is available by prescription only.
- FDA-cleared number K192386.
NDC number designation for 1 oz. tubes is 60006093401 - ICD-10 Code: L589 Radiodermatitis, unspecified
- ICD-9 Code: 69282 Radiodermatitis, unspecified
Note to Doctors: KeraStat® Cream is best used prophylactically by applying to the radiated skin as soon as after the first dose.
Patients who are having symptoms of radiotherapy induced dermatitis (radiation dermatitis) and patients who will be receiving radiotherapy in the future can get sample instructions here to give to your healthcare provider.
10 Things to Do From Home to Manage or “Prevent” Radiation Dermatitis
Nearly 95% of cancer patients undergoing radiation therapy experience radiation dermatitis. Unfortunately, there is no consensus treatment option for preventing or managing radiation dermatitis.
Here are some things you can do from home to protect your skin and ease your radiation burn symptoms:
- Wash your irritated skin with mild soap and lukewarm water.
- Don’t rub or scratch your irritated skin.
- Don’t use heating pads or ice on your treatment area.
- Use moisturizing cream as directed.
- If you cover your treatment area with bandages, secure the bandages with paper tape so you don’t pull on your skin. Try to place the tape away from your treatment area and don’t put the tape in the same place each time.
- Wear loose, soft clothing that doesn’t rub against or irritate skin affected by radiation.
- If you need to shave your treatment area, use an electric razor to avoid irritating your skin.
- Stay out of the sun. Wear protective clothing any time you’re exposed to sunlight. Ask your healthcare provider if you should use sunscreen and what kind of sunscreen is best.
- Stay cool. Your skin may feel better if you’re able to spend time in cool humid environments. Use cool mist humidifiers to banish dryness.
- Talk to your provider before putting anything on your treatment area. This includes cosmetics, hair removal products, powders, creams, lotions, oils, ointments, and perfumes.
Thanks to advances in medical technology and human-derived keratin bioscience, new prescription (Rx) treatments for radiation dermatitis are possible. KeraStat® Cream is now available to help manage radiation dermatitis and its symptoms. Ask your radiation oncologist or physician’s assistant in oncology about KeraStat® Cream.
- Hegedus F, Mathew LM, Schwartz RA. Radiation dermatitis: an overview. International Journal of Dermatology. 2017;56:909-914. PMID 27496623.
- Kole AJ, Kole L, Moran MS. Acute radiation dermatitis in breast cancer patients: challenges and solutions. Breast Cancer – Targets and Therapy. 2017;9:313-323. PMID 38503074.
How to Treat Radiation Dermatitis
According to the Cleveland Clinic, healthcare providers (Radiation Oncologists and Physician’s Assistants in Oncology) may recommend creams that help treat severe radiation dermatitis (aka rad derm) or radiation burns.
Symptoms of rad derm:
- Redness (erythema)
- Soreness
- Pigmentation changes (skin color)
- Itching
- Flaking (desquamation)
- Peeling
- Blistering
- Ulceration (sores)
- Necrosis (death of all or most of the skin cells)
Over the counter (OTC) store bought creams can hydrate the skin and may also increase barrier function but have limited efficacy for treating, delaying, or managing the symptoms of rad derm1,2. Efficacy is defined as
how well something works.
Additionally, advances in medical technology and human-derived keratin bioscience have led to new, prescription strength (Rx) treatments and management options for radiation burn or radiation dermatitis. KeraStat® Cream is available to help manage radiation dermatitis and its symptoms. KeraStat® Cream supports the management of dry, light, and moderately exuding partial thickness wounds. Partial thickness wounds are defined as wounds that only go into one or two of the first two layers of skin. The outermost skin layer is the epidermis, and the inner skin layer is the dermis.
- Hegedus F, Mathew LM, Schwartz RA. Radiation dermatitis: an overview. International Journal of Dermatology. 2017;56:909-914. PMID 27496623.
- Kole AJ, Kole L, Moran MS. Acute radiation dermatitis in breast cancer patients: challenges and solutions. Breast Cancer – Targets and Therapy. 2017;9:313-323. PMID 38503074.
What is Radiation Dermatitis?
What is Radiation Dermatitis and what causes it?
Modern radiation therapy (RT) utilizes a series of small doses of ionizing radiation to kill cancer cells and shrink tumors. Your health care provider’s goal with this therapy is to kill tumor cells after repeated radiation exposures while limiting harm to surrounding healthy cells1. Radiation dermatitis (RD; also known as radiation-induced dermatitis, rad derm, or radiation-induced skin injury) is a term used to describe a spectrum of common skin reactions, or skin toxicities that are caused by radiation therapy.
What are the Symptoms of Radiation Dermatitis?
The stages of RD have been well-defined and progress in a predictable, radiation dose-dependent manner2. As early as the first dose of radiation therapy, when the cumulative radiation dose is still low, mild reactions such as skin redness (i.e., erythema) can occur. As you receive more and more treatments, moderate reactions such as dry, flaky skin (i.e., dry desquamation) and severe reactions such as oozing skin (i.e., moist desquamation) may appear3. It is possible to have some radiation dermatitis symptoms occur a few weeks or months after your last treatment4.
Who will get Radiation Dermatitis?
As mentioned, symptoms and their progression (stages) are quite predictable. What is not predictable is who will exhibit symptoms of RD and who will not. Health care providers (HCPs,) like your Radiation Oncologist, recognize that physiological differences in people make it difficult to predict or pinpoint those who are susceptible to radiation dermatitis symptoms. Talk to your doctor about your physical characteristics that may make you more likely to exhibit symptoms.
7 physical characteristics to talk to your radiation oncologist about concerning the likelihood of symptoms:
- Weight
- Skin color
- Diabetes
- Breast size
- Location of cancer
- Age
- Comorbidities: other diseases or medical conditions you may have
If you have Radiation Dermatitis, how is it treated or prevented?
Your HCP will typically suggest that you keep the radiated area clean with warm water and fragrance-free soap. Your provider may also suggest prophylactic (preventative) use of products to reduce or delay the effects of radiation dermatitis. There are currently no known ways to prevent radiation dermatitis; however, there are products on the market to help manage the symptoms or delay the onset of symptoms. Consult with your health care provider to see if applying KeraStat® Cream after your first radiation dose is right for you and your radiation therapy journey.
You can also find additional information in our News blog post here.
- Zeman E. The biological basis of radiation oncology. In: Gunderson LL, Tepper JE, Bogart JA, editors. Clinical radiation oncology. 4th ed. Philadelphia,
PA: Elsevier, 2016. - Kole AJ, Kole L, Moran MS. Acute radiation dermatitis in breast cancer patients: challenges and solutions. Breast Cancer – Targets and Therapy. 2017;9:313-323. PMID 38503074.
- Leventhal J, Young MR. Radiation dermatitis: recognition, prevention, and management. Oncology. 2017 Dec 15;31(12):885-7, 894-9. PMID 29297172.
- Iacovelli NA, Torrente Y, Ciuffreda A, et al. Topical treatment of radiation-induced dermatitis: current issues and potential solutions. Drugs in Context 2020;9:2020-4-7. 2020 PMID 32587626.
KeraNetics Awarded $3.5 Million Contract for KeraStat® Cream to Manage Cutaneous Radiation Injury
Winston-Salem, N.C., March 18, 2022 – KeraNetics Inc. announced today that it has been awarded a contract in the amount of $3.5 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services. This contract extends previous work conducted by KeraNetics with BARDA support on the FDA-cleared product KeraStat® Cream.
Winston-Salem, N.C., March 18, 2022 – KeraNetics Inc. announced today that it has been awarded a contract in the amount of $3.5 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services. This contract extends previous work conducted by KeraNetics with BARDA support on the FDA-cleared product KeraStat® Cream.
Dr. Luke Burnett, the CEO and Chief Science Officer at the Company, as well as the Principal Investigator for the project, said “KeraNetics is excited to be working with BARDA on this project. KeraStat® Cream already received FDA clearance for use by cancer patients all over the US for radiation dermatitis. This project seeks to conduct the necessary pivotal studies to expand the product indications in management of Cutaneous Radiation Injury or CRI, which is a more severe condition than most radiotherapy patients experience. Treatments for CRI are also critical to the government’s emergency preparedness efforts against CRI that may result from exposure of the large population to nuclear fallout.”
The research and development in this project will be conducted by KeraNetics’ scientists under the direction of Dr. Burnett in partnership with BARDA. “This work will solve a critical need for the US government and further develop possible medical countermeasures for managing radiation exposure injuries to the skin. The unfortunate events of the last month have reminded us all that radiation injury is still a threat. Additionally, this work will also benefit patients suffering from the often painful skin injuries they experience after radiation therapy, and could redefine the standard of care for this condition. We are grateful to BARDA for the opportunity to conduct this research,” said Dr. Burnett.
This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50122C00017.
About KeraNetics Inc. – KeraNetics is the global leader in the development and manufacturing of purified keratin medical products. Headquartered in Winston-Salem, NC, KeraNetics is developing first-in-class therapeutic medical products.
For more information visit www.keranetics.com or contact Luke Burnett, CEO and Chief Science Officer. 336-725-0621, [email protected]
What Are Radiation Burns?
Radiation burn, or radiation dermatitis, can be a side effect of radiotherapy treatments for cancer. It is estimated that more than 90% of the 4 million Americans receiving radiation therapy treatments will develop radiation burn or radiation dermatitis. Symptoms typically include redness, soreness, pigmentation changes, itching, flaking, peeling, blistering, ulceration, or necrosis.
Prevention of Radiation Dermatitis or Radiation Burns
Nearly 90% of cancer patients undergoing radiation therapy experience radiation dermatitis. Unfortunately, patients have been told in the past that there is no consensus treatment option for preventing or managing radiation dermatitis. Thanks to advances in medical technology and keratin bioscience, new treatments for radiation dermatitis are possible. KeraStat® Cream is now available to help manage radiation dermatitis and its symptoms.
How to Treat Radiation Dermatitis or Radiation Burns
According to the Cleveland Clinic, healthcare providers may recommend creams that help treat severe radiation dermatitis or radiation burns. Additionally, advances in medical technology and keratin bioscience have led to new treatment and management options for radiation burn or radiation dermatitis. KeraStat® Cream is now available to help manage radiation dermatitis and its symptoms. KeraStat® Cream supports the management of dry, light, and moderately exuding partial thickness wounds.
Manage Radiation Dermatitis with KeraStat® Cream
KeraStat® Cream is intended to manage dermatology wounds and skin toxicities. These types of wounds and toxicities can include radiation dermatitis that occurs as a side effect of breast cancer radiotherapy treatment. Federal law restricts the sale of KeraStat® Cream to sale by or on the order of a physician. If you are a patient undergoing radiation therapy or who is experiencing radiation dermatitis, consult with your doctor to see if KeraStat® Cream is a good option for you. KeraNetics™ is able to provide resources and educational materials for doctors and other medical professionals.
More Information about Radiation Dermatitis
For more information about Radiation Dermatitis, we recommend reading A Guide to Radiation Dermatitis.
If you are a patient undergoing radiation therapy or who is experiencing radiation dermatitis, consult with your doctor to see if KeraStat® Cream is a good option for you. KeraNetics™ is able to provide resources and educational materials for doctors and other medical professionals.
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KeraNetics Highlighted as Leading Bioscience Company by Livability Magazine
Livability Magazine recently highlighted KeraNetics™ as one of the leading bioscience companies in Winston-Salem. KeraNetics™ was highlighted for its bioscience advancements on treating and managing radiation burns. Additionally, FDA approval for our KeraStat® Cream to help manage wounds and skin toxicities, like radiation dermatitis, was noted as a significant achievement.
KeraStat® Cream is intended to manage dermatology wounds and skin toxicities. These types of wounds and toxicities can include radiation dermatitis that occurs as a side effect of breast cancer radiotherapy treatment. Federal law restricts the sale of KeraStat® Cream to sale by or on the order of a physician.
A Guide to Radiation Dermatitis
Radiation dermatitis (RD) refers to a spectrum of skin reactions that may occur as a result of radiation therapy. Around 85 percent of cancer patients who undergo radiation therapy experience moderate to severe skin reactions. These reactions can be a frustrating and discouraging side effect for cancer patients. Fortunately, advances in medical technology and keratin bioscience have paved the way to manage RD. If you are a medical provider or a patient undergoing radiation therapy, keep reading to learn more.
Symptoms
Radiation dermatitis is a result of radiation burn and is classified as a skin toxicity by dermatologists. Skin reactions to radiation therapy can range from mild symptoms, such as erythema (redness), to moderate symptoms, such as dry desquamation (dry, flaky skin), and even to severe symptoms, like moist desquamation (oozing skin). Symptoms can also progress from mild to severe over time, especially as a patient continues to undergo radiation treatment.
Symptoms of radiation dermatitis may include, but are not limited to:
- Redness
- Soreness
- Pigmentation changes
- Itching
- Flaking
- Peeling
- Blistering
- Ulceration
- Necrosis
Causes
Radiation dermatitis is a skin toxicity caused when the skin is repeatedly exposed to radiation. In the course of radiation therapy, X-ray beams pass through the skin and can cause tissue damage to the skin structure. Depending on the frequency of radiation treatments, the skin may not have enough time to heal between doses. As a result of this unhealed damage, the skin begins to show symptoms.
Prevention and Treatment of Radiation Dermatitis
In the past, cancer patients undergoing radiation therapy have been told that there is no consensus treatment option for preventing or managing radiation dermatitis. Thanks to advances in medical technology and keratin bioscience, new treatments for radiation dermatitis are possible. KeraStat® Cream is now available to help manage radiation dermatitis and its symptoms. KeraStat® Cream supports the management of dry, light, and moderately exuding partial thickness wounds. Patients who apply KeraStat® Cream after the first radiation therapy session should see a noticeably shortened period of erythema (redness). Best of all, KeraStat® Cream is easy to apply. KeraStat® Cream is available by prescription only.
If you are a patient undergoing radiation therapy or who is experiencing radiation dermatitis, consult with your doctor to see if KeraStat® Cream is a good option for you. KeraNetics™ is able to provide resources and educational materials for doctors and other medical professionals.
Sign up for an account with us to subscribe to our newsletter to stay up to date on our latest news! We have information for patients and medical professionals.
Advancements in Burn Treatments and Products Drive Industry Growth
A recent report by DelveInsight projects that the market for burn treatments, including treatments for radiation burns and management of radiation dermatitis, will grow 1.96% annually from 2018 to 2030. Advancements in burn care treatments and products, such as KeraStat® Cream or KeraStat® Gel by KeraNetics, Inc, is a key factor in the report’s analysis of the burn market.
