Laserscope announces FDA clearance for Pseudo-Folliculitis
Folliculitis is the inflammation or superficial infection of the hair follicle. It is often the result of injury or damage to the hair follicle caused by shaving or friction from clothing. Pseudofolliculitis barbae (PFB), commonly referred to as "shaving bumps," "razor bumps" or "ingrown hairs," is a condition occurring primarily in men and women of African or Middle Eastern descent.
PFB is caused as the hair, often in the beard area, grows into and under the adjacent skin and forms a small curled mass, or aggregation of cells, within the skin. Aggravated by shaving, the skin can become chronically inflamed and sometimes infected. In some cases, the constant aggravation can be quite painful and can result in scarring and discoloration of the skin. The problem has an incidence estimated from 20-60 percent in African American men and is of particular concern in the military services.
"We are very excited to be the first and only company to have been granted marketing clearance by the FDA for the treatment of PFB" said Eric Reuter, Laserscope President and CEO. "We believe our clinical results are unmatched by any other technology or treatment modality currently available and having FDA clearance to market for this indication adds another potent application to this multi-specialty laser system.
"Since there are no other known effective ways to address this condition, we believe that many people who suffer from it will seek treatment when they are made aware that it is available. We are working with our existing and new customers to market their practices and bring awareness to this potentially large and untapped pool of patients."
E. Victor Ross, MD, who led the clinical study for Laserscope, said "The clinical results I have seen using the Lyra laser system, especially for darker Type IV, V, and VI skin, are extremely promising and encouraging. Pseudofolliculitis barbae is one of the most prevalent medical conditions treated in the military and is also a significant issue for many African American, African, Middle Eastern, Hispanic and Asian men in general.
"For many years, we have been seeking a solution to the problems of shaving bumps. The Lyra laser, with it's longer wavelength and EDP technology, appears to effectively treat PFB without any side effects such as hypopigmentation or blistering which are often experienced with other laser systems. I have also found Lyra to be extremely fast and easy to use."
Added Reuter, "The Lyra's laser energy selectively kills the hair follicles that cause PFB. The Lyra's unique combination of proprietary pulsing technology, pre-, parallel, and post-treatment epidermal cooling, and wide range of delivery devices provide the physician with a wide range of treatment options for all patient skin types. This further demonstrates that the Lyra is the most versatile aesthetic laser on the market today."