Evaluating facial pores and skin texture afterlow-energy nonablative fractional 1440-nm laser

treatments

Nazanin Saedi, MD,a Kathleen Petrell, BS,a Kenneth Arndt, MD,a,b,c and Jeffrey Dover, MD, FRCPCa,b,d,e

Chestnut Hill and Boston, Massachusetts; Providence, Rhode Island; New Haven, Connecticut; and

Hanover, New Hampshire

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Background: The fractionated nonablative 1440-nm laser creates microscopic thermal wounds within theepidermis and the dermis and is used clinically to improve tone, texture, and color of skin.

Objective: We sought to investigate the use of this device to treat facial pores and to improve skin texture.

Methods: Twenty patients received 6 treatments at the highest tolerable energy level performed 2 weeksapart. Photographic assessments using the VISIA-CR (Canfield Scientific Inc, Fairfield, NJ) imaging systemwere performed. The pore score was calculated, which is the percentage of the skin surface that hasdetected pores. Subjective measurements (0-4 scale) were recorded by both the subject and investigatorregarding pore appearance, skin texture, and overall skin appearance. Treatment discomfort was scored bypatients (1-10 scale).

Results: After 6 treatments there was a significant reduction in pore score (P\ .002). Total average porescore at baseline was 2.0596 0.8 and 2 weeks after the final treatment it was 1.7006 0.8, resulting in a 17%average reduction in pore score. Study investigators reported average scores being 1.956 0.3 for improvedpore appearance and 2.75 6 0.2 for improved overall appearance (0-4 scale). Subjects noted averagescores of 1.9 6 0.5 for improvement of the appearance of pores and 2.85 6 0.4 for improvement of overallappearance (0-4 scale). The average discomfort score during treatments was reported to be 4.6 6 0.1 (1-10scale). There were no serious adverse effects or long-term side effects.

Limitations: Small sample size and limited follow-up are study limitations.

Conclusions: A series of treatments with the nonablative low-energy fractional 1440-nm laser appears tobe safe and effective for reducing detectable pores and improving overall skin appearance. ( J Am AcadDermatol 2013;68:113-8.)

Key words: facial rejuvenation; fractionated lasers; lasers; light devices; nonablative resurfacing; pore size.

First introduced by Manstein et al1 in 2004, theuse of fractional laser energy has quicklybecome an essential component of laser-

based medical and aesthetic treatments. Fractionalphotothermolysis involves the application of narrowbeams of high energy, which create a pixilated

SkinCare Physicians, Chestnut Hill,a and the Departments of

ermatology at Brown Medical School, Providence,b Harvard

edical School, Boston,c Yale School of Medicine, New Haven,d

d Dartmouth Medical School, Hanover.e

orted by a research grant from Solta Medical Inc.

licts of interest: None declared.

nted at the American Society of Laser Medicine and Surgery

SLMS) AnnualMeeting in Kissimmee, Florida, on April 21, 2012.

appearance on the surface of the skin. The focalzones of treatment, or ‘‘microthermal zones,’’ arenarrow cylinders of tissue damage surrounded byadjacent relatively unaffected tissue. These sur-rounding areas of sparing act as reservoirs for heal-ing, enabling the microthermal zones to resolve

Accepted for publication August 4, 2012.

Reprint requests: Nazanin Saedi, MD, SkinCare Physicians, 1244

Boylston St, Chestnut Hill, MA 02467. E-mail: nsaedi@gmail.

com.

Published online October 24, 2012.

0190-9622/$36.00

� 2012 by the American Academy of Dermatology, Inc.

http://dx.doi.org/10.1016/j.jaad.2012.08.041

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quickly by providing a foundation of structural andnutritional support and a reservoir for keratinocytemigration.1 The tissue injury created with fractionalphotothermolysis stimulates the process of collagenremodeling and promotes elastic tissue formation,both of which are necessary for skin rejuvenation.Nonablative resurfacing creates this tissue injury

CAPSULE SUMMARY

d Nonablative 1440-nm laser is afractionated device that createsmicroscopic thermal wounds within theepidermis and the dermis. To date, thereare no objective data on the effects ofnonablative fractionated resurfacing onpores.

d After 6 treatments with a nonablative1440-nm fractionated device, there was a17% average reduction in pore score,which is the percentage of the skinsurface with detectable pores. Therewere no long-term side effects and noserious adverse effects.

d Enlarged pores can be safely treatedusing nonablative fractionated devices.

without visibly damagingthe epidermis.

Currently, nonablativefractional resurfacing is mostcommonly used to treat pho-toaging2,3 and acne scarring.4

The appearance of enlargedfacial pores is a frequentconcern for patients.Although there is a sugges-tion that intense pulsed lighttreatments5,6 and nonabla-tive fractional resurfacingmay help to minimize poresize, no prospective studieswith objective data havebeen performed to confirmthis finding. This study spe-cifically sought to investigatethe use of a low-energy non-ablative 1440-nm fractionallaser (Clear 1 Brilliant laser

system, Solta Medical Inc, Hayward, Calif) for reduc-ing the detectable pores and the appearance of facialpores.

METHODSThis was a prospective, single-arm, nonrandom-

ized study that investigated the safety and efficacy ofa series of treatments with the nonablative fractional1440-nm laser. The study was approved by theBioMed Institutional Review Board, San Diego,Calif, and was conducted from August 2011 toNovember 2011.

Twenty subjects were enrolled in the study, andall subjects were screened to ensure that they met allinclusion criteria and none of the exclusion criteriabefore enrollment in the study. During the baselinevisit, study investigators evaluated wrinkles using theFitzpatrick Wrinkle Scale (1-9), and assigned skintype (Fitzpatrick I-VI).

The subjects received a total of 6 full-face treat-ments with a 2-week interval between treatments.Treatment parameters used in this study were limitedto 3 settings: low energy (4 mJ/pulse), mediumenergy (7 mJ/pulse), and high energy (9 mJ/pulse).A total of 8 passes were used for all facial treatmentregions. The laser has a maximum of 9% coverage

per pass, a fixed spot size of 150 �m, and up to 500microthermal zones/cm2/pass.

Before each treatment, photodocumentation wasperformed with the VISIA-CR (Canfield Scientific Inc,Fairfield, NJ). The VISIA-CR imaging system usesanalysis scripts toprecisely detect,measure, and countphotographic evidence of the appearance of pores by

calculating the pore score,which is the percentage ofthe skin surface that has de-tected pores (values from0-100). The VISIA-CR porescores for front, left, and rightfacial areas were recorded be-fore each treatment and 2weeksafter thefinal treatment.

After each treatment, sub-jective improvements in ap-pearance of pores, skintexture, and overall appear-ance of the face were as-sessed by study investigatorsand subjects. There were nobaseline subjective assess-ments of pores, skin texture,or overall appearance of theface. The quartile improve-ment scale (Table I) withvalues from 0 to 4 was used

to assess any changes in the treated areas after eachtreatment.

An anesthetic ointment containing 30% lidocainewas applied to the face for 30 minutes beforetreatment. Subjects were asked to assess pain sensa-tion during treatment using a 0-to-10 visual analogscale (10 = most painful), and posttreatment heatsensation using a 0-to-3 (3 = severe) severity scale.Study investigators also recorded posttreatmentresponses including erythema, edema, and any otherside effects using the same 0-to-3 severity scale.

A follow-up visit occurred 2 weeks after the finallaser treatment, and subjects were evaluated for sideeffects and changes (prolonged erythema, edema,skin darkening or lightening in the treatment area,scarring, itchiness, dryness, flaking, and blistering).Subjects also rated their satisfaction with the treat-ment results, using a Likert satisfaction scale (1-5)shown in Table II.

RESULTSTwenty subjects, 1 male and 19 female, were

enrolled in the study, aged 29 to 50 years with ameanage of 40 (68) years. A range of Fitzpatrick skin typeswere represented: 5% (1) Fitzpatrick skin type I, 20%(4) Fitzpatrick skin type II, 60% (12) Fitzpatrick skin

Table II. Likert satisfaction scale

1 = Very dissatisfied2 = Dissatisfied3 = Neither satisfied nor dissatisfied4 = Satisfied5 = Very satisfied

Table I. Quartile improvement scale

0 = No improvement1 = Minor/mild improvement (1%-25%)2 = Moderate improvement (26%-50%)3 = Marked improvement (51%-75%)4 = Very significant improvement (76%-100%)

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type III, 10% (2) Fitzpatrick skin type IV, and 5% (1)Fitzpatrick skin type VI. Using the FitzpatrickWrinkleScale from 1 to 9, themean baseline score as assessedby study investigators was 3.0 6 1.1, which corre-sponds to mild wrinkling with mild elastosis.

The average laser treatment setting (1 = low, 2 =medium, 3 = high) used on the face across alltreatments was the high setting (2.80 6 0.03). Alltreatments were performed in the planned 2-weekintervals (63 days) until a total of 6 treatments werecompleted for each subject.

The total average pore score measured by theVISIA-CR imaging system at baseline was 2.0596 0.8compared with 1.700 6 0.8 at the last visit, 2 weeksafter the final treatment (Fig 1). The pore score is thepercentage of the skin surface that has detected pores(values from 0-100). VISIA-CR results showed a 17%average reduction in pore score after 6 treatments.Based on paired differences t test performed on alldeltas (change from baseline to 2 weeks after the lasttreatment (posttreatment 6) of the left, right, and frontpore scores) the differences were highly significant(P # .002).

Study investigators noted improvements in all ofthe assessed areas at each visit (Fig 2). The improve-ment in the appearance of pores, skin texture, andoverall appearance continued to increase as thetreatment series and study visits progressed (Fig 2).At the last visit, 2 weeks after the final treatment, studyinvestigators rated the appearance of pores, skintexture, and overall appearance as moderate tomarked improvement. On the 0-to-4 scale, the aver-age scoreswere 1.956 0.3 for the improvement in theappearance of pores and 2.756 0.2 for improvementinoverall appearance correlating tomoderate ([50%)to marked (51%-75%) improvement.

Subjects also noted clinical improvement in theappearance of pores, skin texture, and overall

appearance (Fig 3). Subject-rated efficacy scoreswere similar to study investigator scores with anoverall average of moderate to marked improve-ment. Similar to study investigator assessments, sub-ject self-assessments demonstrated continuingimprovement as treatments progressed. At the lastvisit, 2 weeks after the final treatment, the averageclinical improvement for the appearance of poreswas 1.96 0.5 and for overall appearance was 2.8560.4 (on a 0-4 scale) correlating to moderate ([50%)to marked (51%-75%) improvement. Figs 4 and 5depict subject assessment of the improvement in theappearance of pores and overall skin appearanceafter 6 treatments compared with baseline.

Average pain sensation during treatments wasreported to be 4.6 (60.1) on a 1-to-10 scale. Themean scores (0-3 severity scale) for erythema andedema were 1.84 6 0.1 and 0.7 6 0.2, respectively,corresponding to mild-moderate erythema and tomild edema. Subjects were also asked to assess heatsensation immediately after treatment using a 0-to-3severity scale. Mean scores for heat sensation aftertreatment were 1.80 on a 1-to-3 scale, correspondingto mild-moderate heat sensation.

At the last visit, 2 weeks after the final treatment, 6subjects (30%) presented with mild erythema. Ofsubjects, 10% (2) presented with dryness and 5% (1)presented with flaking. There were no cases ofedema, hyperkeratosis, hyperpigmentation, orhypopigmentation.

Subject satisfaction ratings of the treatment resultsat the last visit were very high, and the average scoreon a 1-to-5 scale was 4.3 6 0.7. Patient satisfactionratings significantly correlated (P = .001) with im-provement in overall appearance.

DISCUSSIONOver the past few years, fractional laser devices

have been used to treat photoaging1-3 and acnescarring.4 Nonablative fractional photothermolysishas also been demonstrated to be effective in treatinga variety of other conditions including striae disten-sae,7 poikiloderma of Civatte,3 melasma,8 residualhemangiomas,9 minocycline-induced hyperpigmen-tation,10 granuloma annulare,11 disseminated super-ficial actinic porokeratosis,12 and colloid millium.13

Although this technology has a wide range of appli-cations, it has not been demonstrated to be effectivein reducing the appearance of facial pores.

The clinical results of this study show that thenonablative fractional 1440-nm laser is safe andeffective in reducing detectable pores, improvingskin texture, and improving overall facial appear-ance. VISIA-CR results showed an objective 17%average reduction in pore score after 6 treatments.

Fig 1. Average (Avg) VISIA-CR (Canfield Scientific Inc, Fairfield, NJ) pore scores from baselinethrough 2-week follow-up visit (2W FU ); 95% confidence intervals are included. N = 20. Tx,Treatment.

Fig 2. Subjective assessments. Study investigators rated clinical improvement in appearance ofpores, skin texture, and overall appearance for facial areas after each treatment (Tx) and at2-week follow-up (2W FU ) (post Tx 6); 95% confidence intervals are included for all data sets.N = 20. Avg, Average.

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Study investigators rated the appearance of pores,skin texture, and overall appearance as moderate tomarked improvement after 6 treatments. Subject-rated efficacy scores were similar to study investiga-tor scores with an overall average of moderate tomarked improvement. The treatments were welltolerated. Erythema and edema were mild and tran-sient and there were no other significant side effects.

Intense pulsed light devices have been evaluatedfor treating the appearance of pores. Bitter5 evaluatedthe visible effects of intense pulsed light on photo-aging, which includes epidermal and dermal atro-phy, rough skin texture, irregular pigmentation,telangectasias, laxity, and enlarged pores. A total of49 subjects with varying degrees of photodamagewere treatedwith an average series of 4.91 treatments

at 3-week intervals using an intense pulsed visiblelight source (Vasculight, ESC/Sharplan, Norwood,Mass). In the study, 67% (33) reported at least a 50%improvement in the appearance of their pores.Sadick et al6 studied the effects of a series of treat-ments with a combination of intense pulsed opticalenergy and bipolar radiofrequency energy (AuroraSR, Syneron, Yokneam, Israel). In all, 108 patientsreceived 5 treatments every 3 weeks. Subjectivecalculation based on assessments made by thedouble-blinded physicians’ photographic evaluationdemonstrated a 65.1% improvement in the appear-ance of pores. In both studies, there was only asubjective evaluation of the appearance of pores.

Although enlarged pores are a common problem,to our knowledge, this is the first study to assess the

Fig 3. Subjective assessments. Subjects rated clinical improvement in appearance of pores,skin texture, and overall appearance for facial areas after each treatment (Tx) and at 2-weekfollow-up (2W FU ) (post Tx 6); 95% confidence intervals are included for all data sets. N = 20.Avg, Average.

Fig 4. Pore appearance, subject 4: 30-year-old womanwith photographs at baseline (A) and at 2-week follow-upvisit after 6 treatments (B).

Fig 5. Pore appearance, subject 20: 35-year-old womanwith photographs at baseline (A) and at 2-week follow-upvisit after 6 treatments (B).

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reduction of detectable pores using a low-energynonablative fractional laser devicewith objective andsubjective measurements. Limitations of this studyinclude a small sample size (n = 20) and lack of acontrol arm. Another limitation of the study is theshort follow-up time of only 2 weeks after the finaltreatment. Are the changes structural and permanentor simply a temporary alteration in the appearance ofthe pores? A larger, longer, controlled trial confirmingthese findings iswarranted. A question that remains isthe mechanism that caused the pores to becomeundetectable. Possible explanations could be ther-mal damage to the pore, and alteration or destructionof the sebaceous glandwith concomitant alteration inthe pore size. Histologic evaluation of treated skinmight help to solve this and other questions.

CONCLUSIONThe clinical results of this study demonstrate that

the nonablative fractional 1440-nm laser is safe andeffective in reducing detectable pores, improving skintexture, and improving overall facial appearance.

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