Xclair™ Cream Overview

Xclair™ Cream for the treatment of radiation dermatitis
A New Standard of Care in the Treatment of Radiation Dermatitis

• Water-based cream with barrier-forming properties (*1)
• Transparent to radiation therapy (*1)
• Well tolerated (*1)
• Active Ingredients
  • Hyaluronic acid – increases hydration (*2)
  • Glycyrrhetinic acid – reduces inflammation (*2)
  • Anti-protease and antioxidant compounds – reduce cell damage (*2)

Xclair™ Cream is an aqueous cream containing sodium hyaluronate (or hyaluronic acid) that is formulated to relieve symptoms associated with radiation dermatitis. Sodium hyaluronate is the key water-regulating substance in human skin. Harsh conditions and aging decrease sodium hyaluronate content, making the skin rough and dry. In solution, sodium hyaluronate has high viscoelasticity and lubricity. When sodium hyaluronate solution is applied on the surface of skin, it forms an air permeable layer that keeps skin moist and smooth. Small molecular weight sodium hyaluronate can penetrate into the dermis where it combines with water to promote microcirculation, nutrient absorption, and metabolism.



Excellent Safety and Tolerability

• Steroid and immunomodulator free
• Alcohol free
• Fragrance free

No observed or reported adverse events – comparable to placebo (*1).



Application

Beginning on day one of radiation therapy, Xclair™ Cream should be applied to affected skin areas three times a day, or as needed, and massaged gently into the skin. If the skin is broken, the affected area should be covered with a sterile dressing after application. There are no known interactions between Xclair™ Cream and any other products (*1).



Ingredients

Emollient base of Xclair Cream
Xclair™ Cream is an oil-in-water emollient emulsion designed to help keep skin moist and alleviate itch and pain. Two distinct solubility coefficients within the emollient base provide (1) rapid onset of moisturizing action due to the immediate availability of water-soluble components and (2) prolonged replenishment, due to the slow release and migration of the oil-soluble components.

Hyaluronic acid
Xclair™ Cream contains the hydrating, barrier-forming, moisturizing ingredient sodium hyaluronate (hyaluronic acid). Hyaluronic acid has traditionally been used as a lubricant in ocular and orthopedic surgery. The presence of high molecular weight hyaluronic acid induces tissue hydration by encouraging moisture retention and creating a barrier to maintain skin integrity. These functions of hyaluronic acid are due to its ability to hold ~1000 times its weight in water that can be delivered to the skin. An additional barrier mechanism may also protect the wound site and optimize conditions for self-healing.

Telmesteine and Vitis vinifera
Telmesteine and Vitis vinifera are reported to have anti-protease activity that inhibits harmful enzymes produced by damaged skin. Telmesteine has also shown scavenging action on free radicals and protective action against oxidizing agents responsible for epithelial damage.

Vitis vinifera is a plant (grape vine) that contains proanthocyanidin in its stems, seeds, and skins. Proanthocyanidins are among the most potent antioxidants in nature. They attract and neutralize free radicals (the principal agents of skin aging) and prevent oxidative damage to vascular endothelium (tissue that lines blood vessels). In addition, proanthocyanidins form a barrier against enzymes involved in the destruction of elastin, collagen, and other substances that maintain skin integrity.

Proanthocyanidin also contains essential fatty acids similar to those that occur naturally in the skin’s hydrolipidic barrier. These fatty acids nourish and restructure skin, restoring elasticity and firmness. Vitis vinifera in Xclair™ Cream has a well-defined chemical profile, and its preparation guarantees constancy in the different ratios of the compounds.

Shea butter
Shea butter, a mixture of saturated and unsaturated fats (including linoleic acid), is extracted from the seeds of Butyrospermum parkii. It is commonly used for its protective and softening action on the skin. It is particularly useful for maintaining elasticity and turgidity for conditions that lead to sensitive and reddened skin.

Additional ingredients
Xclair™ Cream also contains glycyrrhetinic acid and vitamins C and E. Glycyrrhetinic acid is reported to have an anti-inflammatory action, whereas vitamins C and E assist in the management of radiation dermatitis by improving the wound environment. DMDM hydantoin is included as a preservative.

Please refer to the Package Insert for specific product and prescribing information.

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References: 1. Primavera G, Carrera M, Pinnaro P,Messina M, Arcangeli G, Beradesca E. A double-blind, randomized, placebo-controlled clinical study to evaluate a topical hyaluronic acid-based, hydrolipidic treatment for radiation dermatitis. Presented at: ECCO 13—The European Cancer Conference; October 30-Novemeber 3, 2005; Paris, France. 2. Xclair Cream [package insert]. Cary, NC: ALIGN Pharmaceuticals; 2005.