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Follow on Google News | HairMax LaserComb Clinical Trial Results in Females With Hair Loss Released at 2011 AAD MeetingAt the 2011 American Academy of Dermatology (AAD) Meeting beginning February 4, 2011 the results of a double blind, device controlled clinical study of females with Androgenetic Alopecia treated with the HairMax LaserComb® Lux 9 will be released .
By: Lexington International, LLC Clinical research studies on the treatment of androgenetic alopecia in females have traditionally been difficult to conduct, so this study was carefully designed. The trial was designed as a double blind, multi-center, device controlled study in females, complied with Good Clinical Practice Guidelines (GCP), and was monitored by Palm Beach CRO (Contract Research Organization) Internal analysis indicates that the clinical study met its primary end point of increasing hair counts and was considered a success. Lexington has submitted a 510(k) application with these data, to the FDA for clearance for marketing for the treatment of certain classes of androgenetic alopecia in females. Hereditary hair loss effects approximately 30 million females and up to 50 million males in the United States. In the ten years that the HairMax has been on the market, hundreds of thousands of men around the world have enriched their lives from treating their hair loss with the HairMax LaserComb. Mr. David Michaels, Managing Director of Lexington, said: “We are pleased with the results of this clinical study and the filing of the 510(k) with the FDA”. Mr. Michaels further stated: “The successful outcome of this clinical trial reaffirms our leadership position in the research and development of products for the treatment of hair disorders.” Mr. Randy Veliky, Operating Officer of Lexington, stated: "The completion of this study enables us to take a major step forward in our quest to make the HairMax LaserComb available all over the world to appropriate individuals suffering from genetic hair loss.” # # # About Lexington International, LLC Based in Boca Raton, Lexington International is a manufacturer and developer of advanced medical laser devices to treat hair loss and scalp disorders. Lexington International markets the only laser phototherapy device cleared for marketing by the FDA to promote hair growth in men suffering from certain classes of Androgenetic Alopecia. The company, was one of just 14 leading manufacturing exporting companies nationwide to receive the 2009 U.S. President’s “E” Award, which recognizes successes in world markets and subsequent contributions to the U.S. economy. Over the past 8 years and in over 135 countries worldwide, Lexington Int., LLC has helped hundreds of thousands of individuals to treat their hair condition. (www.hairmax.com) End
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