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CLINICAL APPLICATION o Patient selection

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Guidelines should include treating a broad surface area at appropriate fluences and carefully selecting patients in their 30s to 70s, who have medium quality skin thickness and mild-to-moderate jawline and neck laxity. Treating areas on and adjacent to the described laxity may also improve response rate. The thyroid region of the anterior

Skin Tightening with Radiofrequency

neck should be clearly demarcated and excluded from treatment. All skin types can be treated effectively, as dermal heating while simultaneously cooling the epider- mis with RF has not been reported to cause hypo- or hyperpigmentation. Patients with advanced photoaging or more severe skin sagging may still benefit from RF treat- ment, but possibly to a lesser extent. Adjuvant or combi- nation treatment, such as incorporation of infrared or pulsed light is of additional benefit to photoaging patients, making the Galaxy system a viable option. A comprehen- sive grading scale of laxity, rhytides, and all categories of photoaging has been devised, which may be used to predict and select which technology or combination of technolo- gies will most benefit the patient (Tabte +.r).

Patients with mild, moderate, and severe rhytides and photodamage are candidates for nonablative technology;

however, patient expectations must be handled directly.

Patients who are concerned about risk and recovery and are willing to accept minimal efficacy in exchange for minimal risk are the ideal candidates for nonablative approaches. Dark-skinned and tanned patients should be cautioned of the risk of post-treatment dyspigmentation when nonablative lasers, and light sources/ are used in combination with RF. A test spot may be performed on a

Fig. 4.3 Human skin: before (A) and 4 months after (B) treatment with density. (Photograph courtesy of Thermage)

the Thermacool TC, showing epidermal thickening and increased dermal

Categories of skin ageing and photodamage

D o D fo

@ 5

-

3 0 o

1

Grading scate

Rytides

None

Wrinkles in motion, few, superficial Wrinkles in motion, multiple, superficial

Elastosis

None Early, minimal, yellow hue Yellow hue or eafly localized periorbital (po) elastotic beads (eb) Yellow hue, localized po and eb Yellow hue, po and malar eo

Yellow hue, eb involving po, malar and other sites Deep yellow nue, extensive eb with little uninvolved skin Deep yellow hue, eb throughout, comeoones

Erythema telangietasia

None Pink E or few T localized to single site Pink E or several T localized to 2 sites

Red E or multiple T localized to 2

SitES

Red E or multiple T localized to 3 sites

Violaceous E or many T, multiple sites

Violaceous E, numerous T, little uninvolved skin

Deep violaceous E, numerous T throughout

Keratoses

N o n e Few

Several

Multiple, rarge

Many

Little uninvolved skin

No uninvolved skin

Texture

None Subtle irregularity Mitd irregularity in few areas

Rough in few localized sites Rough in several localized areas Rough in multiple localized sites Mostly rough, little

uninvolved skin

Rough throughout Wrinkles at rest,

few, localized, supedicial Wrinkles at rest, multiple, localized, superficial Wrinkles at rest, multiple, forehead, periorbital and perioral sites, superficial Wrinkles at rest, multiple, general- ized, superficial;

few, deep

Wrinkles throughout, numerous e)densively distributed, deep

Localized nl/ml folds, early jowls, early submental/

submandibular (sm) Localized prominent nl/ml folds, jowls and sm

Prominent nl/ml folds, jowls and sm, early neck strands

Deep nl/ml folds, prominent iowls and sm, prominent neck strands

Marked nl/ml folds, iowls and sm, neck redundancy and strands

Dyschromia

None

Few (1-3) discrete small (<5 mm) lentigines

Several (3-6) discrete small lentigines

Multiple (7-10) small lentigines

Multiple small and {ew large lentigines

Many (10-20) small and large lentigines

Numerous (>20) or multiple large lentigines with little uninvolved skin

Numerous, extensive, no uninvolved skin N o n e

Localized to nasolabial (nl) folds

Localized nl and early metalabial (ml) folds

3 . 5

Reproduced with permission from Alexiades-Armenakas MR Rhytides, laxity, and photodamage treated with a combination of radiofrequency, diode laser, and pulsed light and assessed with a comprehensive grading scale. J Drugs Dermatol 2006; 5 (8): 731-8

Descriptive parameter

None Mitd

Mitd

Moderate

Moderate

Advanced

Advanced

6r

high-risk patient prior to the first treatment session and patients should be instructed as to sun avoidance and sunscreen use following treatments. These lasers are avoided in the case of a patient u,ho has received systemic isotretinoin within the preceding 6 months due to the reported increased risk of impaired."vound healing in these individuals Pregnant women are best not treated until after delivery and breastfeeding.

. Ctinical findings

T H E R M A C O O L

To obtain FDA clearance for the esthetic application of the monopolar radiofrequency device, ThermaCool TCrNI researchers undertook a 6-month study to evaluate the device's efficacy and safety Eighty-six subjects received a single treatment on the forehead and temple area with 68 cm2 of tissue'"vith a single pass at settings ranging from 6q-qi T/.-2 T*rantr,-t.rs patients received a nerve block just superior to the eyebrows immediately prior to or shortly after initiation of treatment. Independent scoring of blinded photographs taken 6 months after treatment resulted in Fitzpatrick wrlnkle score improvement of at least I point in 83.20lo (99/ll9) of treated periorbital

Skin Tightening with Radiofrequency

areas AdditionaIIy, 14.3o/ct Q'7/)J'9) of treated areas had no change, and 25'k (3/t19) worsened. Photographic analysis revealed an eyebrow lift of at least 0.5 mm rn 61.570 [40/65) of patients after 6 months (FiS. +.+). Fifty percent (4I/82) of subjects were satisfied or very satisfied with their treatment outcome. Incidence of side effects was lou, and consisted of edema (13.90/o immediately) and erythema (360i immediately) By I month, no subject had signs of edema, and only 3 (3.970) had lingering signs of erythema Rare second-degree burns occurred in 2l firings of 5858 RF exposures, indicating a burn risk of 0 360/o per application. Three patients had sma1l areas of residual scar- ring 6 months after treatment The authors concluded that a single treatment with monopolar RF reduced periorbital rvrinkles, produced lasting brow elevation, and improved eyelid esthetics The authors also concludedthat the safety profile of this device, used by physicians with no previous experience r'vith its operation, was impressive.

In another study, Hsu and Kaminer evaluated 16 patients treated with a single pass on the cheeks, jawline, and/or upper neck. Treatment levels averaged ll3 8J/

cm2 on the cheeks, decreasing to 99.7 J/cm2on the neck.

In post-treatment follow-up phone interviews, 3601, of patients rvho r'r,ere treated at all three sites reported

Fig. 4.4 Eyebrow lift following Thermage treatment, Photographic example of patlent prior to treatment (A) and 4 weeks post-treatment (B)' with a mean li'ft of 3 42 mm (right) and 3 41 mm (left). (Photograph courtesy of Thermage)

Lasers and Lights Volume ll

satisfactory results compared with 25o/o of patients who were treated at only one or two sites. Also, satisfied patients were those treated with higher energies. This study had three important findings:

I Higher treatment fluences generally 1ed to improved or more consistent results.

2 The greater the surface area treated, the better the results.

3. Younger age is a predictor of rncreased efficacy with the Thermage procedure.

These findings have direct implications for refining treat- ment algorithm guidelines. Guidelines should include treating a broad surface area and carefully selecting patients who have medium-quality skin thickness and mild-to-moderate jawline and neck laxity Treating areas on and adjacent to the described laxity may also rmprove response rate. Patients with advanced photoaging or more severe skin sagging may still benefit from ThermaCool TCrM treatment, but possibly to a lesser extent.

Tanzi and Alster [2005) evaluated cheek laxity in 30 patients and neck laxity in 20 patients after one treatment with the ThermaCool TCrM Patients were pretreated with 5-10 mg of oral diazepam as well as topical anes- thetic cream (LMX-506 cream, Ferndale Laboratories, Inc., Fernadale, MI) The cheek treatment area extended from the nasolabial folds to the preauricular margin and down to the mandibular ridge Treatment of the neck extended from the mandibular ridee to the mid-neck.

Fluences ranged from 97 to 144 J/cmt on the cheeks and frorn 74 to 134 J/cm2 on the neck. Mild oost-trearmenr erythema was seen in all patients and periisted up to 12 hours after the procedure. Fifty-six percent of subjects complained of soreness at the treated sites; the soreness resolved with oral nonsteroidal anti-inflammatory medica- tions. Erythematous papules that resolved over 24 hours were observed in 3 patients. One patient developed dys- esthesia along the mandible that resolved over 5 days. No blistering or scarring was observed A quartile grading system was used and independent assessment noted improvement in 28 of 30 patients who were treated on the cheeks and I 7 of 20 patients who were treated on the neck. The 5 subjects who demonstrated no clinical improvement were all older than 62 years. At 6 months, the mean clinical improvement score was 1.53 on the cheeks and L27 on the neck fscale of I = 25-50% inrprove- ment, 2 = 51-75o/o improvement). On a scale of l-10, the average patient satisfaction score was 6.3 for cheek treat- ment and 5 4 for neck treatment.

G A L A X Y A N D V E L A S M O O T H

red laser, and pulsed iight assessed using a comprehensive, quantitative grading scale for the treatment of rhytides, laxity, and the various aspects of photoaging. Among 28 patients treated, a mean improvement of 10.90/o per cat- egory of skin aging per treatment and 260lo overall improve- ment following a mean of 2 6 treatments was observed.

Patient satisfaction on a yes/no scale revealed 71.40lo satisfaction rate

Clinical studies of the Velasmooth for the treatment of cellulite demonstrated a decrease in thish circumfer- ence of I cm and a mean clinical improvement of 500/o I month after 8 twice-weekly treatments at 1-month follow up.

A C C E N T

The Accent bipolar and unipolar RF device was recently FDA-approved for the treatment of rhytides both on face and body A pilot study of 26 patients with cellulite on the thighs and buttocks were treated with two sessions of unipolar RF with the Accent device. In this report, 680/o of the patients achieved volume contraction, as measured by ultrasound from dermoepidermal junction to Camper's fascia. The limitations of the study included large stan- dards of deviation for the measurements and a lack of clinical evaluation of improvement, though photographic data demonstrated significant improvement. It will be interesting and informative to observe the results of the clinical trials in the U.S. In another recently completed study, 30 female subjects with upper thigh cellulite were treated with the Accent unipolar device. A11 subjects were treated six times over the course of l2 weeks. The mean decrease in thigh circumference was 2.45 cm. Of note there were no changes noted with magnetic resonance imaging (MRI) evaluations and blood lipid analysis His- tologic analysis did show fibrosis in the deep dermrs, con- sistent with the clinicai findings of skin tightening (David J. Goldberg, MD, Personal CommunicationJ. Recently Alexiades-Armenakas completed two randomised, blinded, split-design, controlled trials employing the Accent for the treatment of rhytides and laxity on the face and for the treatment of cellulite on the thishs.

On the face, a 4.4-7.3o/o rJuction in rhytides and laxity was detected in blinded evaluations of randomised, split photographs using the comprehensive grading system following four treatments. In the cellulite study, an 80/o quantitative improvement was detected following a mean of 4 treatments by blinded evaluations of randomised, controlled, split-design photographs.

OVERVIEW OF TREATMENT STRATEGY

The combination of bipolar RF and optical or infrared ' Treatment approach

energy was assessed in several studies for the treatment \A4ren treating the face, the physician can essentially look of skin^aging._ln one study, the combination of bipolar RF at the face as two distinct areas: upper and lo*ei f".e and infrared laser demonstrated improvement in rhytides There may be some benefit to treating the entire face in and laxity among 108 patients. Recently, Alexiades- one session, but it is possible to treat Iither the forehead Armenakas utilized the combination of bipolar RF, infra- region or the cheek/jawline region alone. Both treatment

6 j

zones include treatment of the periorbital area (crow's feet) Radiofrequency devices are capable of tightening skin and improving contours. The physician must analyze the three-dimensional facial structure of the patient to assess those areas that would benefit most from tightening. Typically, this would include the forehead/

brow area, as well as the lower cheek, jawline, and sub- mental region

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