Faculty Bibliography Search Results

"Led photomodulation I: Effects of pulsed and continuous wave modes on procollagen products of human skin fibroblasts" [Meeting Abstract]

McDaniel D.H.; Mazur C.; Wilson S.; GERONEMUS R.G.; Weiss R.A.; Weiss M.
Lasers in surgery & medicine 2010 ;42:55-55
EMBASE:70420793  #132910    

Background: The effect of exposure to various pulsed and continuous wave Treatments on human dermal fibroblasts in vitro was studied using ELISA assay procollagen I production as the endpoint measurement. The study was designed to evaluate the complex interactions that occur between the light source and the cell. Study: Human dermal fibroblasts in culture were exposed to a 590/870 nm LED array fixed at 3.8 mW/cm². In the pulsed mode, a matrix of exposure parameters was tested including: msec exposure 'on' times of 1 (single pulse), 10, 100, 250, 500, 1000; msec 'of f times of 10,100, 250, 500, 1000; and total pulse numbers of 1, 10, 100, 250, 500, 1000. In continuous wave mode, a range of fourteen exposure times from 0.5 to 106 msec were tested. Four days after exposure, supernatants from the exposed fibroblasts were collected and assayed. Results: Measuring percent change from control, the parameters tested produced a wide range of responses from 0% change to greater than 90% increase in procollagen I. Pulse duty cycles (msec 'on') of 100 and 250, and msec 'of f of 10 and 100, and number of 100 pulses produced the most procollagen, as did 100 msec and 10,000 msec in continuous wave mode. Conclusion: These experiments show that procollagen production by human dermal fibroblasts in vitro can be modulated using pulsed and continuous wave modes. Responses to pulsed modes reveal a more complex pattern of cellular response to light than continuous wave mode.

"Led photomodulation II: Effect of energy fluence on procollagen products of human skin fibroblasts" [Meeting Abstract]

McDaniel D.H.; Mazur C.; Wilson S.; GERONEMUS R.G.; Weiss R.A.; Weiss M.
Lasers in surgery & medicine 2010 ;42:55-55
EMBASE:70420794  #132909    

Background: Delivery of pulsed or continuous wave 590/870 nm LED light modulates the production of procollagen I by human dermal fibroblasts in vitro. In pulsed mode, the number of pulses and exposure or on time of the LED pulsed mode the duty cycle determines the energy fluence delivered to the target. In continuous wave mode, the cumulative exposure time determines the energy fluence delivered to the target. Study: Human dermal fibroblasts in culture were exposed to a 590/870 nm LED array with an energy density of 3.8 mW/cm².In the pulsed mode, a matrix of exposure parameters were tested including: msec 'on times of 1 (single pulse), 10, 100, 250, 500, 1000; msec with 'of f times of 10, 100, 250, 500, 1000; and total number of pulses of 1, 10, 100, 250, 500, 1000. In continuous wave mode, a range of fourteen exposure times from 0.5 to 10⁶ msec were tested. Four days after exposure, supernatants from the exposed fibroblasts were assayed by ELISA for procollagen I production. Results: For pulsed parameters, procollagen production was highest for energy fluence of 0.01-0.24 J/cm² with a peak around 0.1 J/cm² for parameters of 250/100/100 (msec on/msec/of f/# pulses). Continuous wave highest peaks were at 100 msec and 10,000 msec (0.0004 and 0.04 J/cm² respectively. Conclusion: 0.1 J/cm² using a pulsed 590/870 nm LED parameters of 250 msec 'on' 100 msec 'of f 100 pulses was selected as most effective for procollagen I production.

"Led photomodulation III: Effect of wavelengths and ratio of wavelengths on gene expressions in human skin fibroblasts" [Meeting Abstract]

McDaniel D.H.; Mazur C.; Wilson S.; GERONEMUS R.G.; Weiss R.A.; Weiss M.
Lasers in surgery & medicine 2010 ;42:57-57
EMBASE:70420800  #132908    

Background: A variety of parameters with LED photomodulation can alter cellular response in vitro. The effects of one visible and one infrared wavelength were evaluated to determine the optimal ratio to produce a net increase in dermal collagen by altering the ratio of total energy output of each wavelength. The ratio between the two wavelengths (595 nm and 870 nm) was shifted in 25% increments. Study: Human dermal fibroblasts in culture were exposed to a 595/870 nm LED array with total combined energy density fixed at 4.0 mW/cm². The ratio of 595/870 nm parameters were: 100%/ 0%; 75%/25%; 50%/50%; 25%/75%; and 0%/100%. These ratios were tested using pulsed duty cycle of exposure (250 msec 'on' time/100 msec 'of f time/100 pulses) and examined using commercially available extra cellular matrix and adhesion molecule RT PCR Arrays (SI Biosciences) for gene expression 24 hours post exposure. Results: There were different expression prof iles noticed for each of the ratios studied. Overall, there was an average (in an 80 gene array) of 6% directional expression difference. The greatest increase in Collagen I and decrease in Collagenase (MMP-1) was observed with 75%/25% ratio of 595/870 nm. The addition of increasing ratios of IR wavelengths causes an alteration in the gene expression prof ile. Even when the genes followed the same directional change, the ratios of the wavelengths caused variation in magnitude of expression. Conclusion: Varying the ratios of specific wavelength intensity in multiwavelength light therapy can alter the resulting gene expression patterns.

"Led photomodulation: Effects of different wavelengths and delivery modes on selected human cell types in vitro" [Meeting Abstract]

McDaniel D.H.; Mazur C.; Wilson S.; GERONEMUS R.G.; Weiss R.A.; Weiss M.
Lasers in surgery & medicine 2010 ;42:59-60
EMBASE:70420808  #132907    

Background: LED photomodulation effects on human dermal fibroblasts have been well documented. The effects of various wavelengths of light, on other cell types were evaluated using human dermal papillae, adipose, and retinal pigment epithelial cells. Study: Human dermal papillae (DP), adipocytes, and retinal pigment epithelial (RPE) cells were grown to near confluence in vitro and exposed to selected LED wavelengths in the visible and near IR light range. For DP cells the endpoint measurements were MTT assay, VEGF ELISA and hair growth-related gene expression using RT-PCR. Adipocyte endpoint measurements were leptin ELISA, total glycerol assay, and cytotoxicity measured by adenylate kinase. RPE cells were exposed to 425 nm or UVA1 light to cause cellular damage, post-treated with LED arrays, and stained with fluorescent Annexin V for apoptosis/ necrosis levels; VEGF and IL6 gene expression RT-PCR. Results: A variety of responses were seen in all studies. DP cells demonstrated increased clinically relevant responses in the 623-660 nm range, particularly at 660 nm using selected pulsed or continuous wave modes. Adipocytes demonstrated altered glycerol and leptin levels at 625 nm and 880 nm using pulsed mode. RPE cells showed a 30% decrease in staining and a downregulation of VEGF expression using 590/870 nm pulsed mode. Apotosis and necrosis of RPE cells was decreased from 92% untreated to 62-5% with various wavelengths. Conclusion: LED photomodulation demonstrated the ability to alter the expression of genes of known significance. Further investigation and optimization of parameters is warranted.

"Varying ratios of wavelengths in dual wavelength LED photomodulation alters gene expression profiles in human skin fibroblasts"

McDaniel, D H; Weiss, R A; Geronemus, R G; Mazur, C; Wilson, S; Weiss, M A
Lasers in surgery & medicine 2010 Aug;42(6):540-545
MEDL:20662030  #133776    10.1002/lsm.20947

BACKGROUND AND OBJECTIVE: LED photomodulation has been shown to profoundly influence cellular behavior. A variety of parameters with LED photomodulation can alter cellular response in vitro. The effects of one visible and one infrared wavelength were evaluated to determine the optimal ratio to produce a net increase in dermal collagen by altering the ratio of total energy output of each wavelength. The ratio between the two wavelengths (590 and 870 nm) was shifted in 25% increments. STUDY DESIGN/MATERIALS AND METHODS: Human skin fibroblasts in culture were exposed to a 590/870 nm LED array with total combined energy density fixed at 4.0 mW/cm.. The ratio of 590/870 nm tested parameters were: 100/0%, 75/25%, 50/50%, 25/75%, and 0/100%. These ratios were delivered using pulsed duty cycle of exposure (250 milliseconds 'on' time/100 milliseconds 'off' time/100 pulses) for a total energy fluence of 0.1 J/cm.. Gene expression was examined using commercially available extra cellular matrix and adhesion molecule RT PCR Arrays (SA Biosciences, Frederick, MD) at 24 hours post-exposure. RESULTS: Different expression profiles were noticed for each of the ratios studied. Overall, there was an average (in an 80 gene array) of 6% expression difference in up or downregulation between the arrays. The greatest increase in collagen I and decrease in collagenase (MMP-1) was observed with 75/25% ratio of 590/870 nm. The addition of increasing proportions of IR wavelengths causes alteration in gene expression profile. The ratios of the wavelengths caused variation in magnitude of expression. CONCLUSIONS: Cell metabolism and gene expression can be altered by simultaneous exposure to multiple wavelengths of low energy light. Varying the ratios of specific wavelength intensity in both visible and near infrared light therapy can strongly influence resulting fibroblast gene expression patterns.

"Choosing an alternate light source with a corresponding dose in photodynamic therapy (it's not rocket science, but it is quantum physics!): Determining the PpIX activiation effect" [Meeting Abstract]

Sayre R.M.; Pariser D.; Goldberg D.J.; GERONEMUS R.; Gottschalk R.W.; Dowdy J.C.
Melanoma research 2010 ;20:e74-
EMBASE:70238630  #111810    

Aim: Photodynamic therapy (PDT), a procedure approved in the US for the treatment of actinic keratoses and being investigated for treatment of other skin diseases, involves three components: a photosensitizer, light, and tissue oxygen. A photosensitizer is a chemical compound that can be excited by light at a specific wavelength. In PDT, a photosensitizer or the metabolic precursor to one is administered to the patient. Upon light exposure, the photosensitizer will become excited and energy is transferred from the excited photosensitizer to molecular oxygen in the treated tissue. The reactive oxygen species interact with nearby biomolecules resulting in cell death via apoptosis or necrosis. Methods: A study was conducted to evaluate the spectral output of several potential clinical light sources for PDT and other indications based upon the photosensitizer, protoporphyrin IX, absorption spectrum. The light sources examined included Clearlight(r), Clearlight(r) 100X, OmniLux BlueTM, Omnilux RedTM, Blu-U(r), and Aktilite(r). The spectral irradiance of these clinical sources used for PDT was measured by spectroradiometric techniques to determine specifically how well their emission overlapped with the absorption spectrum of protoporphyrin IX. Results: The results indicated that all sources examined have the potential to be useful in PDT with varying irradiances, ranging from 73 mW/cm² (Aktilite(r)) to 5 mW/cm² (Clearlight(r)). Thus the results of this study provided confirmation that there are various available light sources which could be effective when used in PDT. Conclusion: Dosage/fluence relationships from the various light sources are presented.

"Successful treatment of atrophic postoperative and traumatic scarring with carbon dioxide ablative fractional resurfacing: quantitative volumetric scar improvement"

Weiss, Elliot T; Chapas, Anne; Brightman, Lori; Hunzeker, Christopher; Hale, Elizabeth K; Karen, Julie K; Bernstein, Leonard; GERONEMUS, ROY G
Archives of dermatology 2010 Feb;146(2):133-140
MEDL:20157023  #157600    10.1001/archdermatol.2009.358

OBJECTIVE: To assess the safety and efficacy of ablative fractional resurfacing (AFR) for nonacne atrophic scarring. DESIGN: In this before-and-after trial, each scar received 3 AFR treatments and 6 months of follow-up. SETTING: Private academic practice. PATIENTS: Fifteen women with Fitzpatrick skin types I to IV, aged 21 to 66 years, presented with 22 nonacne atrophic scars between June 1 and November 30, 2007. Three patients (3 scars) were excluded from the study after receiving 1 AFR treatment and not returning for follow-up visits. The remaining 12 patients (19 scars) completed all 3 treatments and 6 months of follow-up. INTERVENTIONS: Each scar received 3 AFR treatments at 1- to 4-month intervals. MAIN OUTCOME MEASURES: Erythema, edema, petechiae, scarring, crusting, and dyschromia were graded after treatment and through 6 months of follow-up. Skin texture, pigmentation, atrophy, and overall appearance were evaluated after treatment and through 6 months of follow-up by the patient and a nonblinded investigator. A 3-dimensional optical profiling system generated high-resolution topographic representations of atrophic scars for objective measurement of changes in scar volume and depth. RESULTS: Adverse effects of treatment were mild to moderate, and no scarring or delayed-onset hypopigmentation was observed. At the 6-month follow-up visit, patient and investigator scores demonstrated improvements in skin texture for all scars (patient range, 1-4 [mean, 2.79]; investigator range, 2-4 [mean, 2.95]), pigmentation for all scars (patient range, 1-4 [mean, 2.32]; investigator range, 1-4 [mean, 2.21]), atrophy for all scars (patient range, 1-4 [mean, 2.26]; investigator range, 2-4 [mean, 2.95]), and overall scar appearance for all scars (patient range, 2-4 [mean, 2.89]; investigator range, 2-4 [mean, 3.05]). Image analysis revealed a 38.0% mean reduction of volume and 35.6% mean reduction of maximum scar depth. CONCLUSION: The AFR treatments represent a safe, effective treatment modality for improving atrophic scarring due to surgery or trauma..

"New technique using combined pulsed dye laser and fractional resurfacing for treating facial angiofibromas in tuberous sclerosis" [Case Report]

Weiss, Elliot T; GERONEMUS, ROY G
Lasers in surgery & medicine 2010 Jul;42(5):357-360
MEDL:20583249  #157598    10.1002/lsm.20939

BACKGROUND AND OBJECTIVE: Tuberous sclerosis (TS) is a well-described genetic disorder that is classically associated with up to hundreds of facial angiofibromas. Due to the progressive nature of the skin lesions and the early clinical presentation, a safe and effective technique for treating these disfiguring skin lesions is needed. STUDY DESIGN/PATIENTS AND METHODS: We report a combinatorial technique for treating the angiofibromas of TS. We present a case series of three TS patients treated with this technique combining pinpoint electrosurgery, pulsed-dye laser treatment, and ablative fractional resurfacing (AFR). RESULTS: In all presented cases, improvement in the number and appearance of facial angiofibromas and erythema is noted. No scarring or adverse events were reported. CONCLUSION: The technique of electrosurgery, pulsed-dye laser treatment, and AFR represents a new and safe therapeutic option for treating facial angiofibromas associated with TS..

"Radiofrequency devices for body shaping: a review and study of 12 patients"

Anolik, Robert; Chapas, Anne M; Brightman, Lori A; GERONEMUS, ROY G
Seminars in cutaneous medicine & surgery 2009 Dec;28(4):236-243
MEDL:20123422  #107273    10.1016/j.sder.2009.11.003

Radiofrequency (RF) devices such as ThermaCool TC (Solta Medical Inc., Hayward, CA) offer a nonablative and noninvasive treatment option for unwanted skin concerns of the head, neck, and body. Relatively fewer studies address RF treatment on the body when compared with the head and neck. The purpose of this report is to investigate the use of the ThermaCool TC system with the novel Thermage Multiplex Tip for the enhancement of body shape. Additionally, this report will review the literature of RF technology with a concentration on body shaping. Twelve subjects underwent ThermaCool TC treatments using the Thermage Multiplex Tip. Waist circumference, standardized photographs, skin laxity score, global aesthetic improvement score, and patient satisfaction surveys were assessed at baseline and several follow-up visits after treatment. Average waist circumference and skin laxity scores decreased after ThermaCool TC treatment, using the Thermage Multiplex Tip at follow-up visits held at 1, 2, 4, and 6 months after treatment. Global aesthetic improvement score and patient satisfaction surveys reflected these objective clinical improvements. RF devices, such as the ThermaCool TC offer a nonablative and noninvasive treatment option for unwanted skin findings of the head, neck, and body.

"Ablative and fractional ablative lasers"

Brightman, Lori A; Brauer, Jeremy A; Anolik, Robert; Weiss, Elliot; Karen, Julie; Chapas, Anne; Hale, Elizabeth; Bernstein, Leonard; GERONEMUS, ROY G
Dermatologic clinics 2009 Oct;27(4):95-105
MEDL:19850197  #179393    10.1016/j.det.2009.08.009

The field of nonsurgical laser resurfacing for aesthetic enhancement continues to improve with new research and technological advances. Since its beginnings in the 1980s, the laser-resurfacing industry has produced a multitude of devices employing ablative, nonablative, and fractional ablative technologies. The three approaches largely differ in their method of thermal damage, weighing degrees of efficacy, downtime, and side effect profiles against each other. Nonablative technologies generate some interest, although only for those patient populations seeking mild improvements. Fractional technologies, however, have gained dramatic ground on fully ablative resurfacing. Fractional laser resurfacing, while exhibiting results that fall just short of the ideal outcomes of fully ablative treatments, is an increasingly attractive alternative because of its far more favorable side effect profile, reduced recovery time, and significant clinical outcome..

"Improvement in arm and post-partum abdominal and flank subcutaneous fat deposits and skin laxity using a bipolar radiofrequency, infrared, vacuum and mechanical massage device"

Brightman, Lori; Weiss, Elliot; Chapas, Anne M; Karen, Julie; Hale, Elizabeth; Bernstein, Leonard; GERONEMUS, ROY G
Lasers in surgery & medicine 2009 Dec;41(10):791-798
MEDL:20014259  #157603    10.1002/lsm.20872

BACKGROUND AND OBJECTIVES: Skin laxity of the body is a growing cosmetic concern. Laxity can result from chronological or photoaging and changes in body dimensions during pregnancy or weight loss. The end result is loose, sagging skin, and localized fat deposits. Liposuction and abdominoplasty or brachioplasty are established approaches to these issues. Patient desire for alternatives to surgical correction has spawned the development of non-invasive body contouring devices. The combination of infrared light (IR), bipolar radiofrequency (RF), vacuum and mechanical massage (Velashape, Syneron Medical Ltd, Israel) has demonstrated efficacy in improving skin appearance and circumference of the thighs [Goldberg et al., Derm Surg 2008; 34:204-209; Fisher et al., Derm Surg 2005; 31:1237-1241; Arnoczky and Aksan, J Am Acad Orthop Surg 2000; 8:305-313; Alster and Tanzi, J Cosmetic Laser Therapy 2005; 7:81-85; Wanitphakdeedecha and Manuskiatti, J Cosmet Dermatol 2006; 5:284-288; Nootheti et al., Lasers Surg Med 2006; 38: 908-912], but only anecdotal evidence has supported its use on other anatomic locations. This study was designed to evaluate the efficacy and safety of Velashape on additional body sites and more rigorously examine the technology's impact on upper arm as well as abdominal and flank circumference. STUDY DESIGN AND METHODS: Subjects were 28-70 years old, skin types I-V. Nineteen subjects underwent 5 weekly treatments of the upper arms, and 10 subjects underwent 4 weekly treatments of the abdomen and flanks. Treatments were performed using Velashape. Circumference measurements, photographs, and subject weights were performed prior to treatment and at 1- and 3-month follow-ups. Subjects were asked to record their treatment satisfaction level. RESULTS: Change in arm circumference, at the 5th treatment was statistically significant with a mean loss of 0.625 cm. At 1- and 3-month follow-ups, mean loss was 0.71 and 0.597 cm respectively. Reduction of abdominal circumference at 3rd treatment was statistically significant with a 1.25 cm mean loss. At 1- and 3-month follow-ups, average loss was 1.43 and 1.82 cm respectively. CONCLUSIONS: This study demonstrates with statistical significance, sustainable reduction in circumference and improvement in appearance of arms and abdomen following treatment with Velashape..

"Physiologic changes in vascular birthmarks during early infancy: mechanisms and clinical implications" [Letter]

Chapas, Anne M; GERONEMUS, ROY G
Journal of the American Academy of Dermatology 2009 Dec;61(6):1081-1082
MEDL:19925934  #157602    10.1016/j.jaad.2009.06.074

"A SIMPLE SOLUTION TO A COMMON PROBLEM" [Meeting Abstract]

Hale, E; Karen, J; Hunzeker, C; Weiss, E; Bernstein, L; Brightman, L; Chapas, A; GERONEMUS, R
Lasers in surgery & medicine 2009 JUL ;15(7):22-22
ISI:000267524700062  #101250    

"Fractionated CO2 laser resurfacing: our experience with more than 2000 treatments"

Hunzeker, Christopher M; Weiss, Elliot T; GERONEMUS, ROY G
Aesthetic surgery journal 2009 Jul-Aug;29(4):317-322
MEDL:19717066  #157606    10.1016/j.asj.2009.05.004

Fractionated carbon dioxide (CO(2)) laser resurfacing combines the concept of fractional photothermolysis with an ablative 10,600-nm wavelength. This technology allows for the effective treatment of rhytides, photodamage, and scars, with shorter recovery periods and a significantly reduced side effect profile as compared to traditional CO(2) laser resurfacing. In this article, the authors review the concept of fractional photothermolysis, the expanding array of indications for use of fractionated CO(2) lasers, and their preferred treatment technique..

"Port wine stain progression: a potential consequence of delayed and inadequate treatment?"

Minkis, Kira; GERONEMUS, ROY G; Hale, Elizabeth K
Lasers in surgery & medicine 2009 Aug;41(6):423-426
MEDL:19588535  #100668    10.1002/lsm.20788

BACKGROUND AND OBJECTIVES: Port wine stains are congenital low-flow vascular malformations of the skin. Unlike hemangiomas, PWS do not involute with time, but rather if left untreated can hypertrophy and develop nodularity. Laser therapy of PWS particularly with pulsed-dye lasers, is a safe, well-established treatment that is successful in the majority of patients, especially for younger patients. Patients that fail to receive treatment early in life may subsequent develop lesions more likely to progress. STUDY DESIGN/PATIENTS AND METHODS: A case report and review of the literature are presented. We report a 43 year-old man born with a port-wine stain on the right side of his face that extended in the V2 distribution on his face. He had undergone several sessions with a pulsed-dye laser, the sequential dual-wavelength (595 nm and 1064 nm) laser and a CO2 resurfacing laser from the age of 26 but failed to follow through with a sufficient number of treatments to prevent hypertrophy. RESULTS: Due to an insufficient number and interval of treatments (with only 7 treatments over 16 years starting at age 26) with the various lasers, the patient's port wine stain continued to progress in color and development of nodularity. CONCLUSIONS: Patients born with port wine stains should have early laser treatment to achieve optimal results. Delay in treatment, as in this patient until age 26, may result in hard to treat PWS that can continue to progress in nodularity. This case illustrates the hypertrophy and nodularity that can occur due to progression of a PWS with failure to follow through with sufficient number of laser treatments.

"Outcomes of childhood hemangiomas treated with the pulsed-dye laser with dynamic cooling: a retrospective chart analysis"

Rizzo, Carina; Brightman, Lori; Chapas, Anne M; Hale, Elizabeth K; Cantatore-Francis, Julie L; Bernstein, Leonard J; GERONEMUS, ROY G
Dermatologic surgery 2009 Dec;35(12):1947-1954
MEDL:19889007  #157601    10.1111/j.1524-4725.2009.01356.x

BACKGROUND: Laser treatment of childhood hemangiomas remains controversial. Previous studies have used outdated technology, resulting in a potential overrepresentation of adverse outcomes. OBJECTIVE: To evaluate outcomes of hemangiomas treated with the most current laser technology. METHODS: A retrospective chart analysis of 90 patients with a median age of 3.0 months and a total of 105 hemangiomas were enrolled over a 2.5-year period. All were treated with the 595-nm long-pulse pulsed-dye laser (LP-PDL) with dynamic epidermal cooling at 2- to 8-week intervals depending on the stage of growth. Exclusion criteria were previous laser, surgical, or corticosteroid treatment. Three reviewers assessed outcomes. RESULTS: Near-complete or complete clearance in color were achieved for 85 (81%) and in thickness for 67 (64%) hemangiomas. There was no scarring or atrophy. Ulceration occurred in one case and resolved during treatment. Hyperpigmentation and hypopigmentation occurred in 4% and 14% of hemangiomas, respectively. CONCLUSION: Early treatment of childhood hemangiomas with the 595-nm LP-PDL with dynamic cooling may reduce the proliferative phase and result in excellent rates of clearing and few adverse events..

"Anemia treatment with Q2W darbepoetin alfa in patients with chronic kidney disease naive to erythropoiesis-stimulating agents"

Silver, M R; GERONEMUS, R; Krause, M; Chen, C Y; Kewalramani, R; Stehman-Breen, C
Current medical research & opinon 2009 Jan;25(1):123-131
MEDL:19210145  #167375    10.1185/03007990802594818

GRANTS:M01 RR000080/RR/NCRR NIH HHS/United States;M01 RR000080-45/RR/NCRR NIH HHS/United States

OBJECTIVE: To evaluate the efficacy and safety of darbepoetin alfa dosed every-other-week (Q2W) to treat anemia in subjects with chronic kidney disease (CKD), not receiving dialysis, who were naive to erythropoiesis-stimulating agent (ESA) therapy. RESEARCH DESIGN AND METHODS: This was an open-label, multicenter, single-arm study enrolling ESA-naive CKD subjects with baseline hemoglobin (Hb) < 11.0 g/dL. Q2W darbepoetin alfa treatment was initiated at a dose of 0.75 microg/kg and titrated to achieve and maintain Hb levels at 11.0-13.0 g/dL. Treatment was administered from week 1 to week 19. MAIN OUTCOME MEASURES: The primary endpoint was the proportion of subjects who achieved Hb > or = 11 g/dL at any study visit, except in week 1. Hb levels, darbepoetin alfa dose, and safety were also assessed. RESULTS: Of the 128 subjects who received at least one dose of darbepoetin alfa and of the subjects who completed the study, 118 (92%) and 112 (97%), respectively, achieved a Hb > or = 11 g/dL in a median time of 5 weeks. Median darbepoetin alfa dose at week 1 and at the time of achieving a Hb > or = 11 g/dL were 60 and 80 microg, respectively. Darbepoetin alfa was well-tolerated, and short-term adverse events were consistent with those expected in CKD subjects. CONCLUSIONS: This study demonstrates that de novo Q2W darbepoetin alfa was effective in correcting and maintaining Hb levels in ESA-naive subjects with CKD who were not receiving dialysis. Study limitations, including lack of a control arm for the study and multiple race information for subjects, must be considered in interpreting the results. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT00112008..

"What lies beneath? A lesson for the clinician. Intraoperative frozen section appearance of persistent basal cell carcinoma after apparent cure with imiquimod 5% cream"

Sukal, Sean A; Mahlberg, Matthew J; Brightman, Lori; Daniel, David R; Mintzis, Medwin M; GERONEMUS, ROY G
Dermatologic surgery 2009 Nov;35(11):1831-1834
MEDL:19691665  #133744    10.1111/j.1524-4725.2009.01300.x

"Three-dimensional surface imaging for clinical trials: improved precision and reproducibility in circumference measurements of thighs and abdomens"

Weiss, Elliot T; Barzilai, Ori; Brightman, Lori; Chapas, Anne; Hale, Elizabeth; Karen, Julie; Bernstein, Leonard; GERONEMUS, ROY G
Lasers in surgery & medicine 2009 Dec;41(10):767-773
MEDL:20014255  #157604    10.1002/lsm.20863

BACKGROUND AND OBJECTIVES: Numerous body contouring and laser-assisted liposuction devices have recently obtained or are seeking FDA clearance, and assessment of efficacy of these devices is largely based upon qualitative comparisons of before and after photographs and measurable changes in patient circumference. The current standard for measuring body circumference in clinical trials involves the use of a standard measuring tape. These manual measurements introduce human error and may incorrectly support or refute a device or procedure's efficacy. A promising alternative to manual measurements is three-dimensional (3D) photography. This technology allows circumference measurements to be performed on 3D digital models. Our objective is to compare the precision and reproducibility of manual versus 3D photographic measurement of body circumference. STUDY DESIGN/MATERIALS AND METHODS: Thirty subjects completed this IRB approved study. Each subject's thighs and abdomen were measured twice by each of two blinded investigators and twice by the 3D system. RESULTS: For right and left thigh circumference, the variance of the replication errors [measurement 1-measurement 2] for the human investigators was 20.5% larger than the variance for the 3D photography system. For abdominal circumference, the variance for the human investigators was 231.3% larger than the variance for the 3D system. CONCLUSIONS: 3D photography is a valuable tool that enables investigators to reliably detect minute changes in body shape; consequently, 3D photography reduces the number of subjects needed to sufficiently power a clinical study. For studies involving abdominal circumference, utilizing 3D photography reduces the number of subjects needed by 1/2 to 2/3..

"Blepharoplasty-like results with periorbital fractional CO2 laser" [Meeting Abstract]

Brightman, L; Sukal, S; Chapas, A; Karen, J; Hale, E; Kim, K; Bernstein, L; GERONEMUS, R
Lasers in surgery & medicine 2008 JUL ;10(7):108-108
ISI:000257425600321  #86855