Study: Oral Patch Treatment Heals Canker Sores in One Day Compared to 120 Hours for Oral Benzocaine Solution
Major Breakthrough for Canker Sore Sufferers
January 2008: A new study published in Drugs in R&D (January 2008) showed that Canker Cover, an oral patch, healed canker sores in one day - five times faster than an oral solution benzocaine treatment. Median healing time was 24 hours for patients treated with Canker Cover, compared to 120 hours for those treated with the benzocaine formula. The patch also demonstrated superior efficacy for pain relief as well as superior tolerability. This study follows an earlier study in which similar results were observed.
A new study proves that Canker Cover heals most canker sores in just one day compared to 120 hours for a representative benzocaine based product. The study, conducted by the Hebrew University, Jerusalem, was published in The January, 2008 issue of Drugs in R&D, a peer reviewed journal.
The study evaluated the efficacy and tolerability of two topical medications for the treatment of canker sores (aphthous stomatitis), Canker Cover, an oral patch and Kanka, a benzocaine based oral solution. Benzocaine and similar acting pain-relieving ingredients are found in the majority of over-the-counter canker sore treatments.
48 patients were enrolled to the study. 7 patients left due to personal reasons. 23 patients were treated with the oral patch containing citrus oil, a carnelite mineral blend and menthol and 20 were treated with the oral solution containing benzocaine and benzoine t.i.d. The oral patch was found to be significantly more effective in terms of healing time andpain relief, and had fewer side effects.
Median healing time was 23.8 hours for the oral patch vs. 120 hours for the oral solution; pain levels were significantly lower among oral patch users after 12 and 24 hours; and more patients reported local side effects when using the oral solution than when using the oral patch users. 86.9% of the oral patch groups would use the treatment again, compared to 50% of the oral solution group.
There was no significant difference between the two treatments regarding overall ease of use of the treatment or patient's ability to speak one hour after application of the drug. However, 35% of the oral solution patients had difficulty swallowing saliva one hour after application, compared to 4% of the oral patch patients.
Regarding side effects, 100% of the patients using the oral solution reported having one or more side effects effect (numbing, tingling, local pain, bad taste) one hour after the application of the medication and throughout the healing process. Those adverse effects (with the exception of bad taste, which was reported by 4 oral solution patients but was not reported at all among oral patch patients) were reported only among 43.5% of the patients using the oral patch, and only one hour after treatment application. After one hour, oral patch users had no measurable side effects
Dr. Shemer concludes: "The oral patch, Canker Cover, was found to be significantly more effective and tolerable than the oral solution (Kanka) in the treatment of aphthous stomatitis."
This new study confirms similar conclusions from a previous study conducted on 248 patients and published in the Journal of Pharmaceutical Sciences (93:2927-2935). In that study, the efficacy of the Canker Cover patch was compared to a similar oral patch without active ingredients. The time of healing was approximately 1 day for Canker Cover, 5 days for the plain patch and 10 days for untreated patients. The average time for pain disappearance was reduced from 134 hours for the untreated patients, to 48 hours for the group treated with plain patches, and to 5 hours in patients treated with Canker Cover. Furthermore, Canker Cover adhered to the sore sore for 8 - 12 hours providing full protection from food and drink irritation.
"The benefit to canker sore sufferers is quite clear", said Dr.Shemer. "The oral patch heals canker sores in a day, stops pain and protects the sore from food and drink irritants for 8 - 12 hours at a time."
Canker CoverTM is a tablet-like patch made from edible ingredients. It adheres to the canker sore within seconds and forms a clear, gel-like protective ‘seal' that lasts 8 to 12 hours. The patch completely stops the pain, protects the sore from tongue, teeth, food, drink and other irritants, and won't come off while eating. While on, the patch releases menthol, sea salt, citrus oil and other nutrients which prevent pain and speed the healing process. For most users, a single patch is all that is needed. As an added benefit, the patch keeps breath fresh. For more details, visit www.cankercover.com.
Complete resolution of the canker sore occurred in a median of 24 hours; the median healing time for the benzocaine patients was 120 hours.
Pain levels were significantly lower after 12 hours and 24 hours for the Canker Cover users than
for those treated with benzocaine.
100% of the benzocaine users reported one or more minor side effects throughout their treatment; only 43% of the Canker Cover users reported side effects but they stopped within the first hour. Side effects for benzocaine included numbness, a foul taste, and dry mouth.
87% of those treated with Canker Cover would use the product again; only 50% of the benzocaine users would use it again.
35% of those treated with the oral solution had difficulty swallowing after treatment compared to 4% of Canker Cover users.
There was no significant difference between the two treatments with regard to ease and convenience of use.
About Canker Sores
Canker sores are shallow, painful sores on the inside of the lips, the inside of the cheeks, or on the gums. They begin as small, reddish swellings. Then they burst, and the ruptured sores are covered with a white or yellow membrane. The edges of the sores are still red, and look like a painful red halo. Without treatment, canker sores heal in 2 to 3 weeks. If canker sores persist or continue to return, a physician or dentist should be consulted to rule out other causes.
Fifty six million Americans regularly get canker sores but teenagers and young adults get them most often, and women are more frequently than men. Nobody knows for sure what causes canker sores, although stress, vitamin B12 or iron deficiencies, menstruation, hormonal changes, and food allergies are all suspected.
Over $146 million is spent each year by those who suffer from canker sores. Canker Cover, marketed by Quantum Health, is available through most drug and food retailers. www.cankercover.com
Study Details: Efficacy and Tolerability Of Once A Day Treatment For Aphthous Stomatitis With An Oral Patch Compared To An Oral Solution
Authors: Avner Shemer, MD, Boaz Amichai, MD, Henri Trau, MD, Boaz Mizrahi, MSc, Abraham J. Domb, Ph.D, Nir Nathansohn, MD, MHA
Study Conducted at: Department of Dermatology, C. Sheba Medical Center, Huzot Clinic, Clalit Health Services, Ashkelon, School of Pharmacy, Faculty of Medicine, The Hebrew University, Jerusalem, Israel.