Xclair is a cream, indicated for the management of radiation-induced dermatitis, including relief and management of the most common signs and symptoms such as pruritus, erythema, burning and pain.

Xclair acts by adhering to the injured tissue to moisturise and reduce the sensitivity of inflamed tissue.

Xclair is a cream, indicated for the management of radiation-induced dermatitis, including relief and management of the most common signs and symptoms such as pruritus, erythema, burning and pain. Xclair is presented in an airless tube containing 50ml cream.

Xclair acts by adhering to the injured tissue to moisturise and reduce the sensitivity of inflamed tissue. It is a hydrolipidic wound dressing, and contains the hydrating, barrier-forming and moisturising ingredient sodium hyaluronate, which may favour tissue hydration and therefore benefit the healing process. To improve the wound environment and therefore mitigate this common skin reaction to radiotherapy, it also contains additional ingredients that have been reported to provide unique benefits as single substances.

Disease overview

Radiation dermatitis is a common skin reaction seen in patients who are receiving radiotherapy as part of their cancer treatment. It is unpleasant and painful, and contributes to poor quality of life in cancer patients in many ways. Damage progresses from erythema, through the flakiness of dry desquamation as the superficial layers of the skin peel away, to wet desquamation as the damaged basal layer starts to be exposed. At higher grades, it can cause interruptions or even cessation of radiotherapy, which in turn may affect the overall outcome for that patient.

The first signs of a skin reaction may appear as early as the first treatment, and a secondary and progressive erythema will usually appear after 10-20Gy (usually during the second or third week of radiotherapy). The progression of the condition depends on the total dose, fractionation, the total duration of treatment, the volume of tissue irradiated and the energy and type of radiation delivered.

Commercial potential

Assuming a consistent rate of cancer incidence across all markets, there is a potential market of approximately 800 units per 100,000 men in the population and 540 units per 100,000 women in the population, in each market. For a country with a population of 20 million this equates to approximately 300,000 units per year, assuming market saturation.

Benefits

At present there is no universally acknowledged best management of radiation dermatitis. Current treatment options vary between emollients, topical corticosteroids, wound dressings and reduction in radiotherapy. Xclair offers additional benefits over emollients without the need for using corticosteroids, which are generally unpopular with patients and clinicians alike. Because of its medical device status, Xclair may be provided to patients without a prescription in most countries.

Stage of development

In the European Union, under the provisions of EEC Directive 93/42/EC Xclair is classified as a Class IIA Medical Device. The Medical Device Directive applies to all EU countries and this means that Xclair can be sold freely within these countries, without further registration requirements. The CE mark signifies the product's conformity with the Directive.

In the USA, Xclair is classified as a prescription and OTC 510(k) Medical Device (Rx).

 

Registered

Xclair has a patent that is in place until 2023. Xclair is a registered trade mark in the EC and Japan.

 

Exclusive distribution agreements on a territory by territory basis.