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A Prospective Clinical and Histological Study to Evaluate
the Efficacy and Safety of Low Energy Micro-Ablative
Erbium YAG Technology for Facial Rejuvenation

INTRODUCTION

A new Erbium:YAG laser employing micro-ablative technology provides a decrease in fine lines and wrinkles in the peri-orbital area in addition to a reduction in the appearance of acne scarring after one treatment. Skin appears brighter, fresher and more rejuvenated after just one treatment.

OBJECTIVE

The purpose of this study is to determine the safety and efficacy of a low energy Erbium YAG laser based upon clinical and histologic analysis.

MATERIALS AND METHODS

Ten subjects (8 female and 2 male) age 18 or older (mean age 33) were randomized into two groups and were treated with the laser on the medium or high setting. Subjects were monitored immediately post-treatment, 5 days and 10 days after treatment. Improvement was measured by the participant, the principal investigator and a blinded investigator 10 days after the treatment session based on the following scale: no improvement, 0-25% improvement, 26-50% improvement, 51-75% improvement, and 76-100% improvement (see table below). Five participants elected to participate in the biopsy group, four subjects had a biopsy pre-treatment and immediately after treatment and one subject had a biopsy pretreatment, immediately after treatment and 5 days after treatment. Subjects were also asked to measure their brownness, redness, swelling, crusting and pain.

Improvements
Participant
Blinded Investigator
Principal Investigator
0%
10%
40%
0%
0-25%
40%
30%
60%
26-50%
10%
20%
10%
51-75%
20%
10%
0%
76-100%
20%
0%
30%


RESULTS

Subjects most commonly reported burning, erythema and mild edema in the treated area. The burning sensation ceased within a few hours after treatment. Mild edema and erythema subsided over the next 48 hours. Patients were instructed to use make-up for the erythema. Desquamation occurred up to 10 days with the majority of subjects achieving complete re-epithelialization within 7 days.

Subjects indicated that their skin felt “tighter”, “smoother”, and “brighter” after just one treatment. Biopsies taken pre-treatment, immediately post treatment with the device and five days post-treatment revealed that immediately post-treatment the cells of the spinous and granular layers in the epidermis were ablated. Five days post-treatment revealed an alteration in the elastic tissue and a thickening of collagen bundles in the papillary dermis consistent with early dermal remodeling were noted.

CONCLUSION

In conclusion, epidermal ablation and mild alteration of the dermal matrix consistent with early remodeling are noted after a single treatment with this novel low energy Er:YAG technology. This technology, as confirmed by the histology, is helpful for skin turnover as well as potentiating new collagen leading to plumper, smoother, and more uniform healthy skin. Dermal remodeling can lead to a decreased appearance of fine lines and wrinkles. (Figure 2) We would recommend this treatment as a “Friday peel” for patients as they can resume normal activities the same day however most subjects indicated they would feel most comfortable having a weekend rest period. Post-treatment patients are to avoid sun exposure and use a bland moisturizer and a sunscreen. Based upon this study protocol and the results, a series of 3 to 5 treatments every 1-2 months is recommended. This treatment series can be customized to suit the individual patient based upon the degree of photoaging. Because the device employs multiple energy levels, each treatment in the series can be tailored to the patient’s needs and desired outcome.

Subjects were asked to rate brownness, redness, swelling, blistering, crusting, and pain that they experienced over the day period of the study. Subjects rated this on a scale of 1 to 10 where 1=none and 10=terrible.

The table below represents the averages based upon the subject’s responses.

Brownness
Redness
Swelling
Blistering
Crusting

Pain

5.0
8.1
4.2
2.2
3.5
5.4

Figure 1.

A 2mm punch biopsy performed five days post-treatment on the high setting. Tissue was fixed in formalin and paraffin embedded prior to staining for elastic fibers. Black lines are decreased elastic fibers that are surrounded by collagen bundles. This is consistent with dermal remodeling.




Figure 2.


A) Pre-Treatment.

B) 10 days post-treatment on the high setting. The post-treatment photo shows a decrease in the appearance of fines lines and wrinkles in the peri-orbital area.


- Neil Sadick M.D., F.A.C.P., F.A.A.C.S Sadick Aesthetic Surgery and Dermatology Clinical professor of dermatology at Cornell University Medical College in New York City
October 17, 2005

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