Evaluating facial pores and skin texture after low-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
Background: The fractionated nonablative 1440-nm laser creates microscopic thermal wounds within the epidermis 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 weeks apart. Photographic assessments using the VISIA-CR (Caneld Scientic Inc, Faireld, NJ) imaging system were performed. The pore score was calculated, which is the percentage of the skin surface that has detected pores. Subjective measurements (0-4 scale) were recorded by both the subject and investigator regarding pore appearance, skin texture, and overall skin appearance. Treatment discomfort was scored by patients (1-10 scale). Results: After 6 treatments there was a signicant reduction in pore score (P \ .002). Total average pore score at baseline was 2.059 6 0.8 and 2 weeks after the final treatment it was 1.700 6 0.8, resulting in a 17% average reduction in pore score. Study investigators reported average scores being 1.95 6 0.3 for improved pore appearance and 2.75 6 0.2 for improved overall appearance (0-4 scale). Subjects noted average scores of 1.9 6 0.5 for improvement of the appearance of pores and 2.85 6 0.4 for improvement of overall appearance (0-4 scale). The average discomfort score during treatments was reported to be 4.6 6 0.1 (1-10 scale). 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 to be safe and effective for reducing detectable pores and improving overall skin appearance. ( J Am Acad Dermatol 2013;68:113-8.) Key words: facial rejuvenation; fractionated lasers; lasers; light devices; nonablative resurfacing; pore size.

irst introduced by Manstein et al1 in 2004, the use of fractional laser energy has quickly become an essential component of laserbased medical and aesthetic treatments. Fractional photothermolysis involves the application of narrow beams of high energy, which create a pixilated

appearance on the surface of the skin. The focal zones of treatment, or microthermal zones, are narrow cylinders of tissue damage surrounded by adjacent relatively unaffected tissue. These surrounding areas of sparing act as reservoirs for healing, enabling the microthermal zones to resolve

From SkinCare Physicians, Chestnut Hill,a and the Departments of Dermatology at Brown Medical School, Providence,b Harvard Medical School, Boston,c Yale School of Medicine, New Haven,d and Dartmouth Medical School, Hanover.e Supported by a research grant from Solta Medical Inc. Conflicts of interest: None declared. Presented at the American Society of Laser Medicine and Surgery (ASLMS) Annual Meeting in Kissimmee, Florida, on April 21, 2012.

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 and per pass, a xed spot size of 150 m, and up to 500 nutritional support and a reservoir for keratinocyte microthermal zones/cm2/pass. 1 migration. The tissue injury created with fractional Before each treatment, photodocumentation was photothermolysis stimulates the process of collagen performed with the VISIA-CR (Caneld Scientic Inc, remodeling and promotes elastic tissue formation, Faireld, NJ). The VISIA-CR imaging system uses both of which are necessary for skin rejuvenation. analysis scripts to precisely detect, measure, and count Nonablative resurfacing creates this tissue injury photographic evidence of the appearance of pores by without visibly damaging calculating the pore score, the epidermis. which is the percentage of CAPSULE SUMMARY Currently, nonablative the skin surface that has defractional resurfacing is most tected pores (values from Nonablative 1440-nm laser is a commonly used to treat pho0-100). The VISIA-CR pore fractionated device that creates toaging2,3 and acne scarring.4 scores for front, left, and right microscopic thermal wounds within the The appearance of enlarged facial areas were recorded beepidermis and the dermis. To date, there facial pores is a frequent fore each treatment and 2 are no objective data on the effects of concern for patients. weeks after the nal treatment. nonablative fractionated resurfacing on Although there is a suggesAfter each treatment, subpores. tion that intense pulsed light jective improvements in apAfter 6 treatments with a nonablative treatments5,6 and nonablapearance of pores, skin 1440-nm fractionated device, there was a tive fractional resurfacing texture, and overall appear17% average reduction in pore score, may help to minimize pore ance of the face were aswhich is the percentage of the skin size, no prospective studies sessed by study investigators surface with detectable pores. There with objective data have and subjects. There were no were no long-term side effects and no been performed to confirm baseline subjective assessserious adverse effects. this finding. This study spements of pores, skin texture, cifically sought to investigate or overall appearance of the Enlarged pores can be safely treated the use of a low-energy nonface. The quartile improveusing nonablative fractionated devices. ablative 1440-nm fractional ment scale (Table I) with laser (Clear 1 Brilliant laser values from 0 to 4 was used system, Solta Medical Inc, Hayward, Calif) for reducto assess any changes in the treated areas after each ing the detectable pores and the appearance of facial treatment. pores. An anesthetic ointment containing 30% lidocaine was applied to the face for 30 minutes before treatment. Subjects were asked to assess pain sensaMETHODS tion during treatment using a 0-to-10 visual analog This was a prospective, single-arm, nonrandomscale (10 = most painful), and posttreatment heat ized study that investigated the safety and efcacy of sensation using a 0-to-3 (3 = severe) severity scale. a series of treatments with the nonablative fractional Study investigators also recorded posttreatment 1440-nm laser. The study was approved by the responses including erythema, edema, and any other BioMed Institutional Review Board, San Diego, side effects using the same 0-to-3 severity scale. Calif, and was conducted from August 2011 to A follow-up visit occurred 2 weeks after the nal November 2011. laser treatment, and subjects were evaluated for side Twenty subjects were enrolled in the study, and effects and changes (prolonged erythema, edema, all subjects were screened to ensure that they met all skin darkening or lightening in the treatment area, inclusion criteria and none of the exclusion criteria scarring, itchiness, dryness, aking, and blistering). before enrollment in the study. During the baseline Subjects also rated their satisfaction with the treatvisit, study investigators evaluated wrinkles using the ment results, using a Likert satisfaction scale (1-5) Fitzpatrick Wrinkle Scale (1-9), and assigned skin shown in Table II. type (Fitzpatrick I-VI). The subjects received a total of 6 full-face treatRESULTS ments with a 2-week interval between treatments. Twenty subjects, 1 male and 19 female, were Treatment parameters used in this study were limited enrolled in the study, aged 29 to 50 years with a mean to 3 settings: low energy (4 mJ/pulse), medium age of 40 (68) years. A range of Fitzpatrick skin types energy (7 mJ/pulse), and high energy (9 mJ/pulse). were represented: 5% (1) Fitzpatrick skin type I, 20% A total of 8 passes were used for all facial treatment (4) Fitzpatrick skin type II, 60% (12) Fitzpatrick skin regions. The laser has a maximum of 9% coverage
d d d

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Table I. Quartile improvement scale

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

Table II. Likert satisfaction scale

1 2 3 4 5 = = = = = Very dissatisfied Dissatisfied Neither satisfied nor dissatisfied Satisfied Very satisfied

type III, 10% (2) Fitzpatrick skin type IV, and 5% (1) Fitzpatrick skin type VI. Using the Fitzpatrick Wrinkle Scale from 1 to 9, the mean baseline score as assessed by study investigators was 3.0 6 1.1, which corresponds to mild wrinkling with mild elastosis. The average laser treatment setting (1 = low, 2 = medium, 3 = high) used on the face across all treatments was the high setting (2.80 6 0.03). All treatments were performed in the planned 2-week intervals (63 days) until a total of 6 treatments were completed for each subject. The total average pore score measured by the VISIA-CR imaging system at baseline was 2.059 6 0.8 compared with 1.700 6 0.8 at the last visit, 2 weeks after the nal treatment (Fig 1). The pore score is the percentage 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 all deltas (change from baseline to 2 weeks after the last treatment (posttreatment 6) of the left, right, and front pore scores) the differences were highly significant (P # .002). Study investigators noted improvements in all of the assessed areas at each visit (Fig 2). The improvement in the appearance of pores, skin texture, and overall appearance continued to increase as the treatment series and study visits progressed (Fig 2). At the last visit, 2 weeks after the final treatment, study investigators rated the appearance of pores, skin texture, and overall appearance as moderate to marked improvement. On the 0-to-4 scale, the average scores were 1.95 6 0.3 for the improvement in the appearance of pores and 2.75 6 0.2 for improvement in overall appearance correlating to moderate ([50%) to marked (51%-75%) improvement. Subjects also noted clinical improvement in the appearance of pores, skin texture, and overall

appearance (Fig 3). Subject-rated efficacy scores were similar to study investigator scores with an overall average of moderate to marked improvement. Similar to study investigator assessments, subject self-assessments demonstrated continuing improvement as treatments progressed. At the last visit, 2 weeks after the final treatment, the average clinical improvement for the appearance of pores was 1.9 6 0.5 and for overall appearance was 2.85 6 0.4 (on a 0-4 scale) correlating to moderate ([50%) to marked (51%-75%) improvement. Figs 4 and 5 depict subject assessment of the improvement in the appearance of pores and overall skin appearance after 6 treatments compared with baseline. Average pain sensation during treatments was reported to be 4.6 (60.1) on a 1-to-10 scale. The mean scores (0-3 severity scale) for erythema and edema were 1.84 6 0.1 and 0.7 6 0.2, respectively, corresponding to mild-moderate erythema and to mild edema. Subjects were also asked to assess heat sensation immediately after treatment using a 0-to-3 severity scale. Mean scores for heat sensation after treatment were 1.80 on a 1-to-3 scale, corresponding to mild-moderate heat sensation. At the last visit, 2 weeks after the nal treatment, 6 subjects (30%) presented with mild erythema. Of subjects, 10% (2) presented with dryness and 5% (1) presented with aking. There were no cases of edema, hyperkeratosis, hyperpigmentation, or hypopigmentation. Subject satisfaction ratings of the treatment results at the last visit were very high, and the average score on a 1-to-5 scale was 4.3 6 0.7. Patient satisfaction ratings signicantly correlated (P = .001) with improvement in overall appearance.

DISCUSSION
Over the past few years, fractional laser devices have been used to treat photoaging1-3 and acne scarring.4 Nonablative fractional photothermolysis has also been demonstrated to be effective in treating a variety of other conditions including striae distensae,7 poikiloderma of Civatte,3 melasma,8 residual hemangiomas,9 minocycline-induced hyperpigmentation,10 granuloma annulare,11 disseminated superficial actinic porokeratosis,12 and colloid millium.13 Although this technology has a wide range of applications, it has not been demonstrated to be effective in reducing the appearance of facial pores. The clinical results of this study show that the nonablative fractional 1440-nm laser is safe and effective in reducing detectable pores, improving skin texture, and improving overall facial appearance. VISIA-CR results showed an objective 17% average reduction in pore score after 6 treatments.

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Fig 1. Average (Avg) VISIA-CR (Canfield Scientific Inc, Fairfield, NJ) pore scores from baseline through 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 of pores, skin texture, and overall appearance for facial areas after each treatment (Tx) and at 2-week follow-up (2W FU ) (post Tx 6); 95% confidence intervals are included for all data sets. N = 20. Avg, Average.

Study investigators rated the appearance of pores, skin texture, and overall appearance as moderate to marked improvement after 6 treatments. Subjectrated efcacy scores were similar to study investigator scores with an overall average of moderate to marked improvement. The treatments were well tolerated. Erythema and edema were mild and transient and there were no other signicant side effects. Intense pulsed light devices have been evaluated for treating the appearance of pores. Bitter5 evaluated the visible effects of intense pulsed light on photoaging, which includes epidermal and dermal atrophy, rough skin texture, irregular pigmentation, telangectasias, laxity, and enlarged pores. A total of 49 subjects with varying degrees of photodamage were treated with an average series of 4.91 treatments

at 3-week intervals using an intense pulsed visible light 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 treatments with a combination of intense pulsed optical energy and bipolar radiofrequency energy (Aurora SR, Syneron, Yokneam, Israel). In all, 108 patients received 5 treatments every 3 weeks. Subjective calculation based on assessments made by the double-blinded physicians photographic evaluation demonstrated a 65.1% improvement in the appearance of pores. In both studies, there was only a subjective evaluation of the appearance of pores. Although enlarged pores are a common problem, to our knowledge, this is the rst study to assess the

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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-week follow-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 woman with photographs at baseline (A) and at 2-week follow-up visit after 6 treatments (B).

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

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reduction of detectable pores using a low-energy nonablative fractional laser device with objective and subjective measurements. Limitations of this study include a small sample size (n = 20) and lack of a control arm. Another limitation of the study is the short follow-up time of only 2 weeks after the nal treatment. Are the changes structural and permanent or simply a temporary alteration in the appearance of the pores? A larger, longer, controlled trial conrming these ndings is warranted. A question that remains is the mechanism that caused the pores to become undetectable. Possible explanations could be thermal damage to the pore, and alteration or destruction of the sebaceous gland with concomitant alteration in the pore size. Histologic evaluation of treated skin might help to solve this and other questions.

CONCLUSION
The clinical results of this study demonstrate that the nonablative fractional 1440-nm laser is safe and effective in reducing detectable pores, improving skin texture, and improving overall facial appearance.
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3. Behroozan DS, Goldberg LH, Glaich AS, Dai T, Friedman PM. Fractional photothermolysis for treatment of poikiloderma of Civatte. Dermatol Surg 2006;32:298-301. 4. Alster TS, Tanzi EL, Lazarus M. The use of fractional laser photothermolysis for the treatment of atrophic scars. Dermatol Surg 2007;33:295-9. 5. Bitter PH. Noninvasive rejuvenation of photodamaged skin using serial, full-face intense pulsed light treatments. Dermatol Surg 2000;26:835-42. 6. Sadick NS, Alexiades-Armenakas M, Bitter P, Hruza G, Mulholland RS. Enhanced full-face skin rejuvenation using synchronous intense pulsed optical and conducts bipolar radiofrequency energy (ELOS): introducing selective radiophotothermolysis. J Drugs Dermatol 2005;4:181-6. 7. Yang YJ, Lee GY. Treatment of striae distensae with nonablative fractional laser versus ablative CO2 fractional laser: a randomized controlled trial. Ann Dermatol 2011;23:481-9. 8. Rokhsar CK, Fitzpatrick RE. The treatment of melasma with fractional photothermolysis: a pilot study. Dermatol Surg 2005;31:1645-50. 9. Blankenship TM, Alster TS. Fractional photothermolysis of residual hemangioma. Dermatol Surg 2008;34:1112-4. 10. Izikson L, Anderson RR. Resolution of blue minocycline pigmentation of the face after fractional photothermolysis. Lasers Surg Med 2008;40:399-401. 11. Karsai S, Hammes S, Rutten A, Raulin C. Fractional photothermolysis for the treatment of granuloma annulare: a case report. Lasers Surg Med 2008;40:319-22. 12. Chrastil B, Glaich AS, Goldberg LH, Friedman PM. Fractional photothermolysis: a novel treatment for disseminated superficial actinic porokeratosis. Arch Dermatol 2007;143: 1450-2. 13. Marra DE, Pourrabbani S, Fincher EF, Moy RL. Fractional photothermolysis for the treatment of adult colloid milium. Arch Dermatol 2007;143:572-4.