HairMax LaserComb Clinical Trial Results in Females With Hair Loss Released at 2011 AAD Meeting

At 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

Feb 2011

Lexington Int’l, developer and manufacturer of the home use, laser phototherapy medical device the HairMax LaserComb, is pleased to announce the successful completion of a six month clinical research study on treatment of females with hereditary hair loss.

The HairMax is presently the only home use device on the market that has FDA Class 2 Clearance for marketing for the treatment of androgenetic alopecia in males. The HairMax is also the only device of its kind to publish the results of the clinical study proving safety and efficacy in males in a peer-reviewed journal.

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).

Evaluation of the results of the trial were conducted in a blinded manner so that the evaluator did not know if the subjects were using the HairMax or the Control Device.

The clinical trial was listed on www.clinicaltrials.gov, which is a registry of federally and privately supported clinical trials conducted in the United States and the rest of the world.

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.”

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