Early clinical research shows that fractional deep dermal ablation is safe and effective for severe photodamage including rhytids, skin laxity and pigmentation problems, says a researcher involved with pivotal FDA trials.
"Fraxel FDDA treatment has the potential to replace traditional CO2 resurfacing and increase the number of ablative laser procedures being performed," says Zakia Rahman, M.D., a board-certified dermatologist and clinical instructor of dermatology at Stanford University, Palo Alto, Calif., and medical director of the Fraxel Laser Clinic.
Dr. Rahman was also a principal investigator on a 30-patient, three-site study that represents the first round of clinical results presented for the prototype Fraxel re:pair system on the face and neck.
"The energy settings we used were anywhere from 5 to 20 mJ," with a total treatment energy of 400 to 1,600 microthermal zones (MTZ)/cm2, though in a subsequent study investigators have used as many as 70 mJ, Dr. Rahman says.
To evaluate results, investigators used their own assessments of clinical digital photographs, plus those of subjects and blinded observers.
"We found Fraxel FDDA treatment to be a very safe procedure after following all the subjects out three months, and nine of them out to a year. There were no incidents of adverse sequelae in any of these subjects," Dr. Rahman tells Dermatology Times.
While it takes 10 to 14 days for skin to completely re-epithelialize after traditional, non-fractional CO2 laser treatments, Dr. Rahman says, "We demonstrated re-epitheliazation in all our patients within 48 hours, regardless of the energy used. The downtime and risk of infection is significantly decreased the quicker the protective skin barrier is replaced."
Key to proper application of the device is an onboard Intelligent Optical Tracking system (IOTS), Dr. Rahman says.
"The laser itself has an intelligent optical mouse that looks at the skin and lays down a very even pattern" of energy, she says.
This is important in fractional treatment, because if one doesn't properly spare normal tissue between microthermal damage zones, Dr. Rahman says, "One can create a risk of scarring and hypopigmentation."
Overall, Dr. Raman says, "We found that not only is Fraxel FDDA treatment safe, but it provides very significant improvements in parameters, including rhytids and pigmentation, as well as skin laxity."
At three months' follow-up, she says, "Eighty-three percent of subjects noticed at least a 50 percent overall improvement, including indices such as texture, deep wrinkles, pigmentation and skin laxity."
Throughout the follow-up period, researchers furthermore noted no scarring or hypopigmentation, Dr. Rahman says.
The same is true for an earlier study involving 24 patients treated on the forearm, some of whom have now been followed for up to two years, Dr. Rahman says.
Conversely, Dr. Rahman says conventional resurfacing can produce hypopigmentation up to one to two years post-procedure, but "with FDDA treatment, we can safely treat necks and other nonfacial areas."
Hyperpigmentation occurred in about 10 percent of patients in the face and neck study (all of whom had skin types I through IV), but it resolved within three months, she says.
In contrast, Dr. Rahman says traditional ablative resurfacing carries a much greater risk of hyperpigmentation, especially in patients of skin types III and higher.
"The main reason traditional ablative resurfacing fell out of favor is safety. Since Fraxel FDDA was shown to improve the safety significantly - as well as downtime - it's a much more feasible procedure" for larger numbers of patients, Dr. Rahman says.