Boca Raton, FL Lexington International, LLC, manufacturer of the HairMax LaserComb®, the only laser home phototherapy device for hair growth to have FDA 510(k) clearance for marketing, is pleased to announce the commencement of a major multi-center clinical study on the treatment of Androgenetic Alopecia (pattern baldness) in females with the HairMax LaserComb.
The HairMax LaserComb is a home laser phototherapy device with proven efficacy that received FDA 510(k) Clearance for Marketing in 2007 for the treatment of certain classes of Androgenetic Alopecia in males. These new clinical studies are designed to measure the safety and efficacy of the HairMax LaserComb in females with certain classes of Androgenetic Alopecia. The studies have IRB approval and will be conducted in a double-blind and placebo controlled manner in accordance with Good Clinical Practices.
Enrollment commenced in October 2009 at 5 research centers around the country. Patients interested in participating in the trial may find further information at the NIH clinical trials registry, www.clinicaltrials.gov (search HairMax).
As many as 80 million Americans have some degree of hair loss with females comprising a major part of this total. People with hereditary baldness suffer a loss of self esteem and therefore, there is a great demand to bring to market effective therapies to ameliorate this condition. Lexington is determined to be at the forefront of this effort.
Leonard Stillman, Director of Professional Services at Lexington states, "Lexington is a major player in the field of hair loss as the HairMax LaserComb has helped hundreds of thousands of men with hereditary hair loss worldwide to effectively treat their condition. The HairMax LaserComb has also become an integral part of the treatment armamentarium of many physicians for treating Androgenetic Alopecia.” Mr. Stillman further states: “The addition of this major patient population segment to the indications for the HairMax LaserComb will complete our efforts to provide effective therapy for all people suffering from hereditary hair loss around the world.”
David Michaels, Managing Director at Lexington said: “We are pleased to embark on this major research effort and this study represents further proof of Lexington’s commitment and dedication to bringing to market effective treatments for conditions of the hair”. Mr. Michaels further stated: “If we receive 510(k) clearance for this indication for the HairMax for use in females it will further solidify Lexington’s worldwide leadership position in the therapeutic area of hair loss.”
About Lexington International, LLC (www.hairmax.com)
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. Over the past 8 years and in over 125 countries worldwide, Lexington Int., LLC has helped hundreds of thousands of individuals improve their appearances with innovative products to treat their hair.
