Thermographic study by International Research Services, NY, July, 1990, to evaluate the effects of Donell™ Correction Cream on human skin following application of 0.1% Retin-A® Cream. Inflamed skin is “hotter” than normal skin due to the dilated blood vessels which bring blood to the body surface. The swollen vessels also account for the redness seen in inflammation. The excess heat can be measured by a technique known as thermography. Patients were treated with Retin-A® on their forearms, with the concomitant application of Donell™ Correction Cream or the placebo. The temperature of the Donell™ Correction Cream treated skin was significantly lower than that of the placebo-treated skin, indicating the ability of Donell™ Correction Cream to reduce the signs of inflammation.

Abstract presented at the American Society for Dermatologic Surgery by Mark G. Rubin, MD, March, 1992, following an evaluation of Donell™ Post-Procedure Ointment as a healing agent after TCA peels. Ten patients underwent face peels using 30–40% TCA. During healing, each patient treated half of the face with a 1% hydrocortisone ointment and the other side of the face with the Donell™ Post-Procedure Ointment. Patients were evaluated at 5 days post peel at which time photos documented that the side treated with the Donell™ Post-Procedure Ointment had re-epithelialized to a greater degree than the side treated with hydrocortisone ointment. All patients showed similar degrees of inflammation on both sides of the face. Results showed that the Donell™ Post-Procedure Ointment has an anti-inflammatory effect at least equal to 1% hydrocortisone ointment, but unlike hydrocortisone, also appears to significantly speed wound healing.

Double blind clinical study published in the Journal of Dermatological Treatment , 1993, "The Anti-inflammatory Effect of a Bovine Cartilage Preparation on Retin-A® Irritation," conducted by The Dermatology Center, Nashville, TN. One hundred eleven patients were placed on the standard Retin-A® regimen and concomitantly used either a cartilage-based product or a placebo. The results evidenced an anti-inflammatory effect of the cartilage-based product, and most dramatically, the cartilage-based product appeared to accelerate the benefits of the Retin-A®. This latter observation demonstrated that cartilage did not inactivate the Retin-A® and, in fact, may potentiate its activity.

Clinical study published in Dermatologic Surgery , 2002, "The Effect of a Mucopolysaccharide– Cartilage Complex Healing Ointment on Er: YAG Laser Resurfaced Facial Skin," conducted by Tanzi, E.L. and Perez, M. at St. Luke's-Roosevelt Hospital, NY. Following Er: YAG laser resurfacing, 19 patients were randomly treated with an MCC healing ointment or Aquaphor for eight days. Mean severity ratings for all variables—erythema, edema and skin erosion—were consistently lower, and improvement tended to occur earlier, for the MCC healing ointment.

Donell has filed patent applications based on studies utilizing in vitro histochemical techniques during which three dramatic discoveries were uncovered:

• MCC has a two-fold effect on skin, not only does it impart an anti-inflammatory action, but also it stimulates the production of Prostaglandins and Interleukins;


• MCC has a synergistic activity in combination with extremely low levels of steroids, such as hydrocortisone;


• MCC has a strong protective action on cell mitochondria (an indicator of cell viability).

The in vitro tissue culture studies showed that MCC imparted an anti-inflammatory action within the first hour of application which appeared to last for up to eight hours. From eight hours to 24 hours following the first application, exposure stimulated the production of Prostaglandin E2 ( PGE2) and Interleukin-6. Since PGE2 and Interleukin-6 may be related to wound and ulcer healing activity, as well as being anti-carcinogenic, these effects would be expected to be observed within 24 hours of application of MCC.

Implications for Treating Rosacea
It is believed that atrophy of the papillary dermis causes the appearance of the dilated dermal capillaries, telangiectasias, to become more pronounced. The anti-inflammatory component of MCC, combined with its potential anti-angiogenic properties, may have important implications in the prevention and/or treatment of these vascular lesions. Studies are underway to determine the extent to which MCC may contribute to the clinical improvement of this aspect of the disease.

Radiation Burn Therapy
There is considerable anecdotal evidence that Donell™ Skin Savers are effective in alleviating the pain and discomfort associated with radiation burn. The products are currently being tested at several cancer centers to determine their therapeutic value in treating radiation burn, the extent to which healing of the surrounding tissue may be accelerated and that the radiation therapy itself is not being compromised.