Background and Objective: Due to the significant risk profile associated with traditional ablative resurfacing, a safer and less invasive treatment approach known as fractional deep dermal ablation was recently developed. We report the results of the first clinical investigation of this modality for treatment of photo- damaged skin. Study Design/Materials and Methods: Twenty-four subjects received treatments on the inner forearm with a prototype fractional CO 2 laser device at settings of 5-40 m…
Read moreBackground and Objective: Due to the significant risk profile associated with traditional ablative resurfacing, a safer and less invasive treatment approach known as fractional deep dermal ablation was recently developed. We report the results of the first clinical investigation of this modality for treatment of photo- damaged skin. Study Design/Materials and Methods: Twenty-four subjects received treatments on the inner forearm with a prototype fractional CO 2 laser device at settings of 5-40 mJ/MTZ and 400 MTZ/cm 2. Clinical and histological effects were assessed by study investigators 1 week, 1 month, and 3 months following treatment. Thirty subjects were then enrolled in a multi-center study for treatment of photo- damage using the same device. Subjects received 1-2 treatments on the face and neck, with energies ranging from 10 to 40 mJ/MTZ and densities ranging from 400 to 1,200 MTZ/cm 2. Study investigators assessed severity of post-treatment responses during follow-up visits 48 hours, 1 week, 1 month, and 3 months following treatment. Using a standard quartile improvement scale, subjects and investigators assessed improvement in rhytides, pigmentation, texture, laxity and overall appearance 1 and 3 months post-treatment. Results: Clinical and histologic results demonstrated that fractional delivery of a 10,600 nm CO 2 laser source offers an improved safety profile with respect to traditional ablative resurfacing, while still effectively resurfacing epidermal and dermal tissue. Forearm and facial treatments were well-tolerated with no serious adverse events observed. Eighty-three percent of subjects exhibited moderate or better overall improvement, according to study investigator quartile scoring. Conclusions: FDDA™ treatment is a safe and promising new approach for resurfacing of epidermal and deep dermal tissue targets. Lasers Surg © 2009 Wiley-Liss, Inc.