Photocure Announces Positive Allumera Trial Results for Delivering Significant Skin Appearance Improvements
US Product Launch Anticipated For Second Quarter, 2011
OSLO, Norway, Feb. 4, 2011 /PRNewswire/ -- Photocure (OSE: PHO), a Norwegian specialty pharmaceutical company focused in dermatology and cancer, today announced positive results from its consumer trial with Allumera™, a breakthrough cosmetic treatment formulated to improve the skin's appearance.
The RevitAll study was performed with a standard cosmetic protocol and designed to confirm if treatment with Allumera™ improves skin appearance, when compared to exposure by light alone. The study also looked into longevity of results.
This controlled, prospective study enrolled 120 women to receive three treatments, four weeks apart. The total duration of the study was five months. Half the study participants received Allumera™ plus light, while the remaining received light alone (control group). Participants were monitored for three months following the last treatment to evaluate which effects were long-lasting. The study evaluations included both objective and subjective assessments. The objective assessments included measurement of pores, skin firmness/elasticity, skin tone (radiance/luminosity), skin surface topography and tolerability.
At the five month evaluation, participants who received Allumera™ for one hour followed by exposure to light, showed a significant 44% reduction in the appearance of pores (p<0.001), when compared to baseline, and the difference between the two groups was statistically significant (p=0.002). A statistically significant improvement (p<0.0001) in skin firmness and suppleness was also observed for the Allumera group when compared to the control group. A 35% improvement in the appearance of skin tone (p<0.05) was also found, but this, however, was not statistically significant when compared to the control group.
"The results from our RevitAll study provide a solid foundation for our efforts to commercialize Allumera™," said Kjetil Hestdal, M.D. Ph.D., President and Chief Executive Officer of Photocure. "It is a significant milestone for our Photocure Technology™ and provides validation for our technology in cosmetic dermatology aimed at improving the skin's appearance. The upcoming launch of Allumera™ is a major step forward in establishing Photocure's US business."
In addition to the objective statistical measurements, Allumera™ demonstrated significant subjective feedback from trial participants including confirmation of:
- Revitalized, younger-looking, clearer and more beautiful skin
- Reduced appearance of crows feet, dark circles, fine lines and wrinkles
- Firmer appearance of skin
- Improvement in the feeling of moisture, smoothness and overall skin texture
"Aesthetic physicians and consumers are always looking for products to improve the appearance of skin," said Terry Conrad, President of Photocure's US subsidiary. "We are very encouraged by the response from our dermatology advisors as to the ability of Allumera™ to fill an unmet need and look forward to a successful second quarter 2011 launch."
Allumera ™ Assists People To Look Beautifully Young, Longer
Allumera™ is a topical cosmetic cream specially formulated to improve the overall appearance of skin. When used with light, Allumera™ works with the body's capabilities to visibly reduce many unwanted skin characteristics, such as the appearance of fine lines, dark circles, crows feet and enlarged pores. Photocure's Allumera™ is a unique skincare formula that is applied by a healthcare professional and has been found to improve the overall appearance of skin, leaving a more radiant, firmer and healthier complexion.
"Allumera™ is an exciting, effective new option to achieve a radiant and supple facial appearance, with minimal downtime," said Mitchel P. Goldman, MD, Volunteer Clinical Professor of Dermatology at University of California, San Diego. "Allumera™ will be a valuable new product filling a gap for our patients looking to discreetly and non-invasively minimize the appearance of wrinkles, dark circles and pores."
Side effects of Allumera™ include mild redness, which typically disappears within two days. Some people may experience slight swelling and or mild dryness which typically subsides within two days. After being treated with Allumera™, it is recommended that patients protect exposed skin from direct sun contact for 48 hours.
Due to positive clinical trials with Allumera™ treatment on facial skin, Allumera™ is currently being studied on other cosmetically important areas, such as the hands, neck, chest, arms and legs.
About Photocure ASA
Photocure ASA is a worldwide leader in photodynamic therapy. Listed on the Oslo Stock Exchange (OSE: PHO), Photocure develops and sells pharmaceuticals and medical devices for the photodynamic treatment and diagnosis of cancer and selected dermatology indications. The company strives to solve unmet needs by developing new and innovative solutions based on its patented Photocure Technology™. Photocure markets and sells its own products in selected markets and has developed strong partnerships with leading pharmaceutical companies on a regional and global basis. Photocure's bladder cancer diagnostic product, Hexvix® is approved in the European Union and the US. Setting new standards for diagnosis and treatment of several different conditions, Photocure Technology™ is very selective preserving healthy tissue. Photocure Technology™ is continuously being tested for new products and indications including acne, improving the appearance of skin, diagnosing colon cancer and the treatment of pre-malignant cervical lesions, among other indications.
Photocure® and Hexvix® are registered trademarks of Photocure ASA. For more information about Photocure, visit our website at www.photocure.com
About Photocure, Inc.
Photocure, Inc. is the US subsidiary of Photocure ASA, located in Princeton, NJ. Photocure, Inc. will focus on the area of dermatology and will introduce its first cosmetic product Allumera™, in the 1st half of 2011.
Blinder, Lippe Taylor Brand Communications, +1-212-598-4400 x147,
Web Site: http://www.photocure.com
Posted: February 2011