National report — People don't take care of their feet, especially women, says Dina Besece, Pharm.D., of JSJ Pharmaceuticals. "We just don't sit down enough," she says. "And at times, we pick shoes for style not comfort."
National report - People don't take care of their feet, especially women, says Dina Besece, Pharm.D., of JSJ Pharmaceuticals. "We just don't sit down enough," she says. "And at times, we pick shoes for style not comfort."
As a result, dry, cracked feet can cause great discomfort and can become a chronic problem if left untreated.
Dr. Besece is a pharmacologist with a background in dermatology, and is the clinical director for JSJ, Doylestown, Pa.
The SanoDerm vehicle was then combined with urea 40 percent, which also has a long history of benefit for dryness by dissolving the intercellular matrix and encouraging scaly skin to shed. Umecta has been on the market for about a year, but the company wanted more than anecdotal proof that the combination of materials provided relief for scaling and cracking feet.
"We wanted to see for ourselves -we wanted documented proof using scientific measurements to show that the product is useful," Dr. Besece says.
Double-blind study Dr. Besece presented a poster at the 63 rd American Academy of Dermatology Annual Meeting of a double-blind study showing the effectiveness of a new technology which combines topically applied EFAs with urea 40 percent to penetrate into the skin and repair the damage to the cracking heels.
Both men and women between 18 and 65 years of age were included in the study and received two tubes, one that had both EFAs and urea, and one that contained simply EFAs. They were instructed to apply one product to the right heel and the other product to the left heel as determined by a randomization design.
Patients were instructed to apply the appropriate test product to the assigned foot each morning and evening and keep a diary of the response of theskin to the product. Fourteen subjects finished the course of the study.
The response of the skin was graded at the beginning, after two weeks and after four weeks on a four-point basis:
1. Clinical evaluation for cracking, dryness, erythema, edema and burning.
2. Ballistometer measurements which measures the softening of the skin through a "bounce profile"- a pendulum is dropped on the skin and the depth of the indentation and the height of the bounce determines the softness of the skin.
4. Self-assessment by the patient.
Results Dr. Besece says the results of the test showed that both the EFA vehicle and the combination product (Umecta) were beneficial.
"While both the SanoDerm vehicle, consisting of EFAs, and Umecta were shown to be beneficial in the patient assessment, the clinical and biometric assessments exhibited that Umecta had better response rates than the SanoDerm vehicle alone.
"At the same time, the SanoDerm essential fatty acid vehicle by itself actually generated better responses from the test subjects in a patient assessment questionnaire when just evaluating dryness," Dr. Besece says.
"The heels looked better in about a week, but the urea appears to make the difference in repairing the actual cracks and fissures in the skin."
The other significant finding of the study, according to Dr. Besece, is that the products showed no adverse side effects.
"The patients reported no stinging, burning, or tingling. So, the product is safe and effective," she tells Dermatology Times.
That's significant because the product is designed for long-term use. Although Dr. Besece says some people may experience short-term cracking of the skin, depending on the cause, for most, this is a chronic problem.