Evaluating facial pores and skin texture after low-energy nonablative fractional 1440-nm laser treatments

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1 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, FRCPC a,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 (Canfield Scientific Inc, Fairfield, 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 significant reduction in pore score (P \.002). Total average pore score at baseline was and 2 weeks after the final treatment it was , resulting in a 17% average reduction in pore score. Study investigators reported average scores being for improved pore appearance and for improved overall appearance (0-4 scale). Subjects noted average scores of for improvement of the appearance of pores and for improvement of overall appearance (0-4 scale). The average discomfort score during treatments was reported to be (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. First introduced by Manstein et al 1 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, Accepted for publication August 4, Reprint requests: Nazanin Saedi, MD, SkinCare Physicians, 1244 Boylston St, Chestnut Hill, MA nsaedi@gmail. com. Published online October 24, /$36.00 Ó 2012 by the American Academy of Dermatology, Inc

2 114 Saedi et al JANUARY 2013 quickly by providing a foundation of structural and nutritional support and a reservoir for keratinocyte migration. 1 The tissue injury created with fractional photothermolysis stimulates the process of collagen remodeling and promotes elastic tissue formation, both of which are necessary for skin rejuvenation. Nonablative resurfacing creates this tissue injury without visibly damaging the epidermis. Currently, nonablative fractional resurfacing is most commonly used to treat photoaging 2,3 and acne scarring. 4 The appearance of enlarged facial pores is a frequent concern for patients. Although there is a suggestion that intense pulsed light treatments 5,6 and nonablative fractional resurfacing may help to minimize pore size, no prospective studies with objective data have been performed to confirm this finding. This study specifically sought to investigate the use of a low-energy nonablative 1440-nm fractional laser (Clear 1 Brilliant laser CAPSULE SUMMARY system, Solta Medical Inc, Hayward, Calif) for reducing the detectable pores and the appearance of facial pores. METHODS This was a prospective, single-arm, nonrandomized study that investigated the safety and efficacy of a series of treatments with the nonablative fractional 1440-nm laser. The study was approved by the BioMed Institutional Review Board, San Diego, Calif, and was conducted from August 2011 to November Twenty subjects were enrolled in the study, and all subjects were screened to ensure that they met all inclusion criteria and none of the exclusion criteria before enrollment in the study. During the baseline visit, study investigators evaluated wrinkles using the Fitzpatrick Wrinkle Scale (1-9), and assigned skin type (Fitzpatrick I-VI). The subjects received a total of 6 full-face treatments with a 2-week interval between treatments. Treatment parameters used in this study were limited to 3 settings: low energy (4 mj/pulse), medium energy (7 mj/pulse), and high energy (9 mj/pulse). A total of 8 passes were used for all facial treatment regions. The laser has a maximum of 9% coverage d d d Nonablative 1440-nm laser is a fractionated device that creates microscopic thermal wounds within the epidermis and the dermis. To date, there are no objective data on the effects of nonablative fractionated resurfacing on pores. After 6 treatments with a nonablative 1440-nm fractionated device, there was a 17% average reduction in pore score, which is the percentage of the skin surface with detectable pores. There were no long-term side effects and no serious adverse effects. Enlarged pores can be safely treated using nonablative fractionated devices. per pass, a fixed spot size of 150 m, and up to 500 microthermal zones/cm 2 /pass. Before each treatment, photodocumentation was performed with the VISIA-CR (Canfield Scientific Inc, Fairfield, NJ). The VISIA-CR imaging system uses analysis scripts to precisely detect, measure, and count photographic evidence of the appearance of pores by calculating the pore score, which is the percentage of the skin surface that has detected pores (values from 0-100). The VISIA-CR pore scores for front, left, and right facial areas were recorded before each treatment and 2 weeks after the final treatment. After each treatment, subjective improvements in appearance of pores, skin texture, and overall appearance of the face were assessed by study investigators and subjects. There were no baseline subjective assessments of pores, skin texture, or overall appearance of the face. The quartile improvement scale (Table I) with values from 0 to 4 was used to assess any changes in the treated areas after each treatment. An anesthetic ointment containing 30% lidocaine was applied to the face for 30 minutes before treatment. Subjects were asked to assess pain sensation during treatment using a 0-to-10 visual analog scale (10 = most painful), and posttreatment heat sensation using a 0-to-3 (3 = severe) severity scale. Study investigators also recorded posttreatment responses including erythema, edema, and any other side effects using the same 0-to-3 severity scale. A follow-up visit occurred 2 weeks after the final laser treatment, and subjects were evaluated for side effects 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 treatment results, using a Likert satisfaction scale (1-5) shown in Table II. RESULTS Twenty subjects, 1 male and 19 female, were enrolled in the study, aged 29 to 50 years with a mean age of 40 (68) years. A range of Fitzpatrick skin types were represented: 5% (1) Fitzpatrick skin type I, 20% (4) Fitzpatrick skin type II, 60% (12) Fitzpatrick skin

3 VOLUME 68, NUMBER 1 Saedi et al 115 Table I. Quartile improvement scale 0 = No improvement 1 = Minor/mild improvement (1%-25%) 2 = Moderate improvement (26%-50%) 3 = Marked improvement (51%-75%) 4 = Very significant improvement (76%-100%) Table II. Likert satisfaction scale 1 = Very dissatisfied 2 = Dissatisfied 3 = Neither satisfied nor dissatisfied 4 = Satisfied 5 = 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 , 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 ( ). 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 compared with at the last visit, 2 weeks after the final 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 for the improvement in the appearance of pores and 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 and for overall appearance was (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 and , 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 final treatment, 6 subjects (30%) presented with mild erythema. Of subjects, 10% (2) presented with dryness and 5% (1) presented with flaking. 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 Patient satisfaction ratings significantly correlated (P =.001) with improvement in overall appearance. DISCUSSION Over the past few years, fractional laser devices have been used to treat photoaging 1-3 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.

4 116 Saedi et al JANUARY 2013 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 efficacy 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 significant side effects. Intense pulsed light devices have been evaluated for treating the appearance of pores. Bitter 5 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 al 6 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 first study to assess the

5 VOLUME 68, NUMBER 1 Saedi et al 117 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).

6 118 Saedi et al JANUARY 2013 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 final treatment. Are the changes structural and permanent or simply a temporary alteration in the appearance of the pores? A larger, longer, controlled trial confirming these findings 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. REFERENCES 1. Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med 2004;34: Jih MH, Goldberg LH, Kimyai-Asadi A. Fractional photothermolysis for photoaging of hands. Dermatol Surg 2008;34: Behroozan DS, Goldberg LH, Glaich AS, Dai T, Friedman PM. Fractional photothermolysis for treatment of poikiloderma of Civatte. Dermatol Surg 2006;32: Alster TS, Tanzi EL, Lazarus M. The use of fractional laser photothermolysis for the treatment of atrophic scars. Dermatol Surg 2007;33: Bitter PH. Noninvasive rejuvenation of photodamaged skin using serial, full-face intense pulsed light treatments. Dermatol Surg 2000;26: 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: Yang YJ, Lee GY. Treatment of striae distensae with nonablative fractional laser versus ablative CO 2 fractional laser: a randomized controlled trial. Ann Dermatol 2011;23: Rokhsar CK, Fitzpatrick RE. The treatment of melasma with fractional photothermolysis: a pilot study. Dermatol Surg 2005;31: Blankenship TM, Alster TS. Fractional photothermolysis of residual hemangioma. Dermatol Surg 2008;34: Izikson L, Anderson RR. Resolution of blue minocycline pigmentation of the face after fractional photothermolysis. Lasers Surg Med 2008;40: Karsai S, Hammes S, Rutten A, Raulin C. Fractional photothermolysis for the treatment of granuloma annulare: a case report. Lasers Surg Med 2008;40: Chrastil B, Glaich AS, Goldberg LH, Friedman PM. Fractional photothermolysis: a novel treatment for disseminated superficial actinic porokeratosis. Arch Dermatol 2007;143: Marra DE, Pourrabbani S, Fincher EF, Moy RL. Fractional photothermolysis for the treatment of adult colloid milium. Arch Dermatol 2007;143:572-4.