Radiation Dermatitis
Understanding Radiation Dermatitis
Radiation therapy can have some unpleasant side effects in the skin. The following are the most common side effects, both acute and chronic, resulting from radiation. Unforeseen side effects may occur because of the unique and varied tolerance of individual persons. Late effects of treatment may not always be predictable and may be influenced by concurrent and/or subsequent treatment for this and other diseases.
What side effects can occur?
Specific side effects of radiotherapy depend on the part of the body being treated as well as the dose given. In general, the first change is a reddening of the skin, resembling a sunburn. In many patients this is all that is experienced. However, like a sunburn, the involved area is often sensitive and even painful to the touch. In addition, the overlying skin may break down and the area may remain open until several days to weeks after the course of radiation is completed.
Once the course of radiotherapy is completed, the redness will gradually go away and any open areas normally will heal. However, the skin in this area may later develop some subtle changes including stiffness and/or dryness, as well as possible pigmentation changes.
What can be done to reduce or prevent these side effects?
Most of the current treatment options involve the use of emollients or aloe gels in an attempt to keep the skin moisturized. However, as most know who have had the experience of a sunburn, moisturization helps the skin from drying out but does not reduce the pain or redness, which are caused by inflammation. DermaMedics scientists have developed DermaRad Relief®, which is a moisturizing lotion that contains Therosol®, a bioactive that is able to reduce skin redness and pain associated with radiation therapy. This product is currently undergoing clinical studies.
Clinical Treatment of Radiation Dermatitis
DermaMedics’ lead compound, Therosol®, has been shown to have pronounced anti-inflammatory activity when tested on human skin cells in culture. Because of the compound’s ability to block the production of a variety of inflammatory mediators, including PGE-2, it seemed likely that topical Therosol® formulations would prove effective in preventing or reducing skin inflammation caused by exposure to the sun (sunburn) or to other forms of radiation, including radiation treatments for cancer.
To test the ability of Therosol® to prevent sunburning, a patient’s forearm was irradiated in two spots with a dose of UVB/UVA radiation (3 MED) sufficient to cause erythema (sunburn). Immediately after the radiation treatment, one spot was treated with a 2% Therosol® lotion, while the other spot was treated with the same lotion that did not contain Therosol® (placebo). Six hours after irradiation, the skin was photographed and the results are shown below. As can be seen, the spot treated with the Therosol® lotion was only slightly pink while the spot treated with the placebo lotion developed pronounced erythema.
In addition to these studies, showing that Therosol® can prevent the onset of sunburning, other studies have shown that Therosol® can actually reverse a sunburn if treatment is started within 6 hours of the onset of a sunburn.
Because of the success of topical Therosol® in preventing sunburn, clinical studies were carried out to determine if Therosol® could prevent the onset of severe burns caused by treatment of the skin with high doses of radiation during cancer radiation treatment.
This IRB approved protocol for this study, entitled “The Ability of Therosol to Inhibit the Development of Radiation Dermatitis” is available upon request. The clinical investigator for this study was Dr. Zoe Diana Draelos, MD, a Board certified and world renowned dermatologist. For this study only breast cancer patients undergoing radiation treatments were used, although to date, this Therosol® formulation has been used to effectively prevent radiation burns in patients being treated for throat, colon, stomach, prostate, rectal, brain, as well as for breast cancer. Of the more than 40 radiation patients using the topical Therosol® formulation, radiation burns have either been significantly reduced or completely prevented in 100% of the patients. This level of efficacy is unheard of even with prescription drugs. Photographs from one breast cancer patient who used the topical Therosol® formulation are shown (right). The left photograph is just a file image showing the severe burning that can occur in breast cancer patients receiving over 30 radiation treatments. The photograph in the center is of a patient in the study who used a 2% Therosol® lotion throughout her radiation treatments. The photograph was taken by the clinical investigator the day after the patient’s 35th radiation treatment. As can be seen below, even after 35 treatments the patient shows no sign of burning. The photograph on the right is of the same patient but taken 1 month after completion of radiation therapy. The clinical investigator was interested in determining if the skin had suffered aging effects, which is a typical result of radiation treatments. For this photograph a macro lens was used on the camera to allow closeup shots of the skin’s surface. As can be seen in the photographs, the patient’s skin is smooth and free of any signs of aging or radiation damage. To quote the clinical investigator, the absence of any radiation-induced damage was “truly amazing”.
As is the case for all radiation patients using this 2% Therosol® topical emulsion lotion, they are not allowed to apply the lotion 4 hours prior to radiation treatments. This ensures that the treated area is completely free of any topical product at the time of radiation. The patients are told to apply the lotion immediately after radiation and then 2 more times during the day.
As mentioned, to date over 40 cancer patients have used this 2% Therosol® lotion and all have received either total or near total protection from radiation burns. A list of the cancer centers and clinics that have used this topical formulation for their patients is available from DermaMedics. For physicians who would like to receive more information about this product, the technology behind it, the IRB protocol, and the patient’s use instructions, please contact the DermaMedics office.