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Skin Rejuvenation Using Intense Pulsed Light a Randomized Controlled Split-Face Trial with Blinded Response Evaluation

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Skin Rejuvenation Using Intense Pulsed Light a Randomized Controlled Split-Face Trial with Blinded Response Evaluation STUDY Skin Rejuvenation Using Intense Pulsed Light A Randomized Controlled Split-Face Trial With Blinded Response Evaluation Lene Hedelund, MD; Eva Due, MD; Peter Bjerring, MD, DMSc; Hans Christian Wulf, MD, DMSc; Merete Haedersdal, MD, PhD, DMSc Objective: To evaluate efficacy and adverse effects of Results: Skin texture was significantly improved at all intense pulsed light rejuvenation in a homogeneous group clinical assessments except at the 6-month examination of patients. (PϽ.006). The improvements peaked at 1 month after treatment, at which time 23 (82%) of 28 patients had bet- Design: Randomized controlled split-face trial. ter appearances of treated vs untreated sides. Most pa- tients obtained mild or moderate improvements, and 16 Setting: University dermatology department. patients (58%) self-reported mild or moderate efficacy on skin texture. Rhytids were not significantly different Patients: Thirty-two female volunteers with Fitzpa- on treated vs untreated sides, and 19 patients (68%) re- trick skin type I through III and class I or II rhytids. ported uncertain or no efficacy on rhytids. Significant im- provements of telangiectasia (PϽ.001) and irregular pig- Interventions: Subjects were randomized to 3 intense Ͻ pulsed light treatments at 1-month intervals or to no treat- mentation (P .03) were found at all assessments. Three ment of right or left sides of the face. patients withdrew from the study because of pain re- lated to treatment. Main Outcome Measures: Primary end points were skin texture and rhytids. Secondary end points were tel- Conclusions: Three intense pulsed light treatments im- angiectasia, irregular pigmentation, and adverse effects. proved skin texture, telangiectasia, and irregular pig- Efficacy was evaluated by patient self-assessments and mentation but had no efficacy on rhytids. Adverse events by blinded clinical and photographic evaluations up to were minimal, but included scar in 1 patient. 9 months after final treatment. Adverse effects were as- sessed clinically and by noninvasive skin reflectance mea- surements. Arch Dermatol. 2006;142:985-990 ONABLATIVE SKIN REJUVE- glass laser (1540 nm). The IPL systems nation is used for the emit polychromatic light in a wavelength treatment of photodam- spectrum of 500 to 1200 nm.5 With the aged skin, including skin aid of different cutoff filters, the spectral texture, rhytids, telangi- range can be narrowed to selectively tar- Nectasia, and irregular pigmentation.1 Treat- get variable structures of the skin.5,6 ments of telangiectasia and irregular pig- Controlled split-face trials, which com- mentation are well established; possible pare treated vs untreated control sites, improvement of skin texture and rhytids have demonstrated the efficacy of visible by nonablative remodeling is widely dis- (532- to 595-nm) and midinfrared (1064- cussed. The mechanism of action is to 1540-nm) lasers for the treatment of 7-11 thought to be based on selective absorp- skin texture and rhytids. tion of light in hemoglobin or tissue wa- ter, leading to the formation of a dermal CME course available at repair zone and subsequent collagen syn- www.archdermatol.com thesis.2-4 Devices in the visible and midin- Author Affiliations: frared parts of the electromagnetic spec- The objective of this randomized con- Departments of Dermatology, trum are used for nonablative remodeling, trolled split-face trial was to evaluate the University of Copenhagen and including intense pulsed light (IPL), po- Bispebjerg Hospital, efficacy and adverse effects of IPL rejuve- Copenhagen (Drs Hedelund, tassium-titanyl-phosphate laser (532 nm), nation, with the primary end points being Due, Wulf, and Haedersdal), pulsed dye lasers (585 and 595 nm), Nd: skin texture and rhytids. The efficacy on and Aarhus University Hospital, YAG lasers (1064 and 1320 nm), diode la- telangiectasia and irregular pigmentation Aarhus (Dr Bjerring), Denmark. sers (532 and 1450 nm), and erbium: was secondarily assessed. To our knowl- (REPRINTED) ARCH DERMATOL/ VOL 142, AUG 2006 WWW.ARCHDERMATOL.COM 985 ©2006 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 01/27/2020 edge, this study is the first randomized controlled split- level of satisfaction concerning rhytids, skin texture, telangi- face trial comparing a treated vs an untreated control ectasia, and irregular pigmentation (using a visual analog scale, site after IPL rejuvenation in a homogeneous group of ranging from 0 [unsatisfied] to 10 [maximum satisfaction]).13 patients. Potential adverse effects such as wounds, erythema, hypopig- mentation, hyperpigmentation, and scars were evaluated clini- cally using a 4-point scale (indicating none, mild, moderate, METHODS or severe). Photographs were taken using a Canon digital cam- era (EOS D30) equipped with a lens-mounted ring flash (Canon Macro Lens EF 100 mm 1:2.8; Canon Inc, Tokyo, Japan). All Thirty-two healthy female volunteers (mean age, 47 years) with photographs were taken in raw format under identical condi- Fitzpatrick skin type I through III and class I or II rhytids were tions and camera settings. Standardized views (en face and 45° treated. Inclusion criteria were nonsmokers with symmetrical oblique) were used, and a single laboratory processed all pho- skin texture, facial rhytids, irregular pigmentation, and telan- tographs. giectasia on the right and left sides of the face. Exclusion cri- Objective measurements of skin pigmentation were per- teria were pregnancy, any visible asymmetry of skin texture and formed by skin reflectance spectroscopy (UV-Optimize, Model facial rhytids, irregular pigmentation, and telangiectasia, any 550/660 nm; Matic, Nærum, Denmark). The instrument mea- sign of infection or inflammatory skin disease, previous for- sures pigmentation (melanin) and redness (hemoglobin) in- mation of hypertrophic scars or keloids, use of oral isotreti- dependent of each other, based on skin reflection of 555- and noin in the past 12 months, current use of aspirin or nonste- 660-nm wavelengths and gives the objective results on wide roidal anti-inflammatory drugs, exposure to UV irradiation biological scales. Zero percent pigmentation corresponds to ab- within the past 4 weeks, and previous skin rejuvenation pro- solutely white skin with no melanin pigmentation at all, and cedures in the facial area. The patients were recruited from the 100% pigmentation corresponds to theoretically absolutely black community by advertisements in local newspapers, and all gave skin without any reflection. The instrument performs 3 inde- informed consent. The study was approved by the human study pendent measurements and gives the mean value at the dis- committee and was conducted from January 12, 2004, to Janu- play.14-17 Three measurements were performed on each side of ary 20, 2005. the face (ie, cheek, periorbital, and perioral regions). Specific The patients were randomized to 3 IPL treatments at 1-month landmarks ensured that measurements were continually taken intervals or to no treatment of the right or left sides of the face. at the same skin area. The randomization was carried out before treatment by pa- Preoperative sample size calculations revealed a required tients’ drawing lots between 2 opaque sealed envelopes con- sample size of 27 patients (based on a .05 significance level, taining “right” or “left” marked cards representing the site for 90% power, 15% uncertainty, and an expected 55% to im- intervention with IPL. Twenty-nine of 32 patients received the prove on treated sides). Nonparametric statistical methods were allocated treatment, and 28 patients completed the study (2 pa- used. The Friedman test and Wilcoxon matched pairs test were tients allocated to treatment on the right side and 1 patient al- used for paired comparisons. Differences between treated vs located to treatment on the left side withdrew from the study untreated control sides were compared using a sign test (bi- before finishing the treatment because of pain related to the nomial test). Descriptive data are presented as median (inter- treatment, and 1 patient allocated to treatment on the right side quartile range [IQR]). withdrew from the study after the final treatment because of lack of time). The IPL treatments were performed with a second- generation IPL system (Ellipse Flex; Danish Dermatologic De- RESULTS velopment A/S, Hørsholm, Denmark), which in contrast to the first-generation system uses dual mode filters that restrict the emitted light to a wavelength band from 530 to 750 nm, in- Blinded clinical evaluations found significant improve- hibiting shorter and longer wavelengths from reaching the skin ments of skin texture at 1, 3, and 9 months after treat- surface. In addition, the pulse is more stable in the second- ment (PϽ.006) on treated vs untreated facial sides, generation IPL system, with only minor pulse decay that re- whereas no significant differences were found at 6 months sults in a more stable spectral light distribution throughout the after treatment (Table 1 and Table 2). The greatest im- pulse duration. Energies varied between 7.5 and 8.5 J/cm2 de- provement was found at 1 month after treatment, when livered at two 2.5-millisecond pulses with a 10-millisecond in- 23 patients (82%) scored better appearances of treated terpulse delay. Because longer wavelengths from 750 through vs untreated sides, with 10 patients (36%), 9 patients 1200 nm are removed, the emitted fluence levels are signifi- (32%), and 4 patients (14%) having marked, moderate, cantly lower than in comparable IPL systems. Before IPL treatment, the skin was covered with a transpar- and mild differences, respectively. At 3 and 9 months af- ent gel to optimize optical coupling between the light guide and ter treatment, the improvements declined, when 11 pa- skin. Postoperative evaluations were performed at 1, 3, 6, and tients (42%) and 15 patients (56%), respectively, scored 9 months after the final treatment. Evaluations were per- better appearances of treated vs untreated sides, with most formed by a blinded independent physician (E.D.) and by pa- patients having small differences. By photographic evalu- tient self-reports.
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