Regulation of Medical Devices for Dermatology.

Medical devices became subject to the current framework of regulation and premarket review by the Food and Drug Administration (FDA) in 1976. Devices are distinguished from drugs by the means in which they achieve their primary intended purposes. All medical devices, regardless of risk, share certain regulatory requirements to assure quality, safety, and transparency. Moderate- to high-risk devices must additionally be cleared or approved by FDA before being introduced into interstate commerce. Dermatologic devices regulated by FDA range from high-power energy-based devices to wound dressings, and from complex electronic devices to topically applied barrier creams.

Efficacy of pulsed dye laser treatment for common warts is not influenced by the causative HPV type: a prospective study.

Verruca vulgaris (VV) is a prevalent skin condition caused by various subtypes of human papilloma virus (HPV). The most common causes of non-genital lesions are HPV types 2 and 4, and to a lesser extent types 1, 3, 26, 29, and 57. Although numerous therapeutic modalities exist, none is universally effective or without adverse events (AE). Pulsed dye laser (PDL) is a favorable option due to its observed efficacy and relatively low AE rate. However, it is not known which verrucae are most likely to respond to PDL, or whether the causative viral subtype influences this response. The objective of this prospective blinded study was to assess whether the HPV subtype was predictive of response to PDL. For that matter, 26 verrucae from 26 immunocompetent patients were biopsied prior to treatment by PDL. HPV coding sequences were isolated and genotyped using PCR analysis. Patients were treated by PDL (595 nm wavelength, 5 mm spot size, 1.5 ms pulse duration, 12 J/cm2 fluence) once a month for up to 6 months, and clinical response was assessed. Binary logistic regression analysis and linear logistic regression analysis were used in order to evaluate statistical significance. Different types of HPV were identified in 22 of 26 tissue samples. Response to treatment did not correlate with HPV type, age, or gender. As no association between HPV type and response to PDL therapy could be established, it is therefore equally effective for all HPV types and remains a favorable treatment option for all VV.

Combined pulsed dye and CO2 lasers in the treatment of angiolymphoid hyperplasia with eosinophilia.

Angiolymphoid hyperplasia with eosinophilia (ALHE) is an uncommon dermatosis of unknown etiology that manifests as characteristic red nodules and papules with a predilection for the scalp and periauricular region. Treatment is required for both esthetic and functional reasons, as lesions may ulcerate and bleed. Many treatment approaches have been reported, including excision, systemic medical approaches, topical or intralesional therapies, and non-invasive modalities including cryotherapy, electrosurgery, and laser. Treatments have exhibited variable efficacy, and the recurrence rate is 100 %. We report the combination of pulsed dye laser and CO2 laser in the treatment of ALHE in 14 patients. All patients exhibited clinical response after a mean of 2.4 ± 0.4 treatment sessions. The clinical efficacy of the combined treatment, together with its well-tolerated nature, render the use of pulsed dye laser in combination with CO2 laser, a viable treatment for debulking ALHE lesions. Ongoing maintenance treatments are needed to due to the high degree of relapse.

Use of reflectance spectrophotometry to predict the response of port wine stains to pulsed dye laser.

Reflectance spectroscopy can be used to quantitate subtle differences in color. We applied a portable reflectance spectrometer to determine its utility in the evaluation of pulsed dye laser treatment of port wine stains (PWS) and in prediction of clinical outcome, in a prospective study. Forty-eight patients with PWS underwent one to nine pulsed dye laser treatments. Patient age and skin color as well as PWS surface area, anatomic location, and color were recorded. Pretreatment spectrophotometric measurements were performed. The subjective clinical results of treatment and the quantitative spectrophotometry results were evaluated by two independent teams, and the findings were correlated. The impact of the clinical characteristics on the response to treatment was assessed as well. Patients with excellent to good clinical results of laser treatments had pretreatment spectrophotometric measurements which differed by more than 10%, whereas patients with fair to poor results had spectrophotometric measurements with a difference of of less than 10%. The correlation between the spectrophotometric results and the clinical outcome was 73% (p < 0.01). The impact of the other clinical variables on outcome agreed with the findings in the literature. Spectrophotometry has a higher correlation with clinical outcome and a better predictive value than other nonmeasurable, nonquantitative, dependent variables.

Treatment of the skin manifestations of hereditary hemorrhagic telangiectasia with pulsed dye laser.

Hereditary hemorrhagic telangiectasia (HHT) is a familial disorder, in which variably sized arteriovenous malformations develop in the skin, respiratory tract, central nervous system, and gastrointestinal and urogenital tracts. Bleeding is a major problem in the abnormal vessels, primarily in the nose and internal lesions. Skin lesions, in contrast, do not generally bleed spontaneously but pose a significant cosmetic concern. The lesions are characteristically small caliber vessels located in the dermis. As such, they are ideal targets for vascular lesions. Eight patients with cutaneous facial lesions of HHT were treated by pulsed dye laser. All patients exhibited excellent (75-100%) clearance after a mean of 2.6 treatments (range 1-8). In comparison, a control group of patients with non-HHT facial telangiectasia required a mean of 1.9 (range 1-5; p < 0.05) treatments. No adverse events were reported in either group. The study confirms the safety and efficacy of PDL in the management of the cutaneous lesions of HHT.

Melasma and laser treatment: an evidenced-based analysis.

The use of lasers in the treatment of melasma has been addressed in case reports, but there is no consensus in the literature regarding the safety, efficacy, or durability of laser-based treatments. Furthermore, given the potential risks of laser intervention in hyperpigmented skin, the relative risks and benefit of laser must be compared to more conservative and traditional treatment approaches. English language literature in which the main intervention was a light-based therapy and the target was melasma was analyzed. The study included only prospective, controlled studies which included at least 10 participants, and which presented the data with accepted objective and quantitative study metrics. Seven studies met the inclusion criteria. Two studies reported the response to melanin-targeting lasers and five reported the response to fractional photothermolysis. The response to lasers was not consistent among the reports. Adverse events including hyperpigmentation were reported in several studies. The durability of melasma improvement was limited in all cases where laser was used as monotherapy. In studies that compared laser to topical treatments, laser-based monotherapy failed to show benefit over topical treatments. This analysis suggests that the use of lasers for the treatment of melasma cannot be recommended, due to unpredictable safety and efficacy, time-limited clinical improvement, and no clear benefit over conventional treatments.

Telangiectasis in CREST syndrome and systemic sclerosis: correlation of clinical and pathological features with response to pulsed dye laser treatment.

Telangiectasia are cardinal features of systemic sclerosis (SS) and calcinosis, Raynaud's syndrome, esophageal motility, sclerodactyly, telangiectasias (CREST) syndrome. The etiology of telangiectasia in these syndromes is unknown, but vascular dysfunction has been proposed. However, the telangiectasia of CREST have anecdotally been considered relatively resistant to pulse dye laser (PDL), the treatment of choice for classic telangiectasia. The study was designed to test whether SS/CREST telangiectasia require more treatments than sporadic telangiectasia and to identify clinical and histological features that could explain such an effect. Nineteen skin biopsies from patients with SS or CREST and 10 control biopsies were examined and compared for features that may predict a differential response to PDL. Sixteen cases of SS or CREST treated with PDL between 1997 and 2007 were evaluated and response to treatment was compared with 20 patients with sporadic telangiectasis. Relative to normal skin, CREST/scleroderma telangiectasia exhibited thickened vessels in 17 out of 19 sections and thickened collagen fibers in the reticular or deep dermis in all sections. The number of treatments required to clear SS/CREST telangiectasia was approximately twofold higher. SS/CREST telangiectasia are more resistant to PDL but can be effectively cleared with more treatments.

Fractional CO2 laser in the treatment of facial scars in children.

Facial scars in children have a profound psychosocial impact and require early and aggressive treatment. In this age group in particular, however, attention must be placed on the methodology so as not to trigger additional trauma-whether physical or emotional-as a sequela to the treatment. We assess the safety and efficacy of fractional CO2 in a prospective study of pediatric facial scars from various etiologies. Twenty four children, age 2-16 years, underwent fractional CO2 laser resurfacing. Recovery, clinical response, and adverse events were monitored at 3 days, 1 week, 1 month, 2 months, and 6 months. Photographs taken before treatment and 2 months after final treatment were independently evaluated and scored by two physicians. All patients tolerated treatment well, with minimal erythema an edema. The clinical improvement was scored as excellent in 14 patients (58%), good in 7 (29%), and fair in 3 (13%). No cases were graded as poor or worse. No adverse events were noted. The study supports the use of fractional CO2 resurfacing of pediatric facial scars as well tolerated and effective. Given the particularly rapid healing and clinical improvement of pediatric skin, fractional CO2 treatment should be offered early to mitigate both the physical and psychosocial stigmata of scars as early as possible.

Treatment of acne scars with hyaluronic acid: an improved approach.

BACKGROUND: Acne scarring is a prevalent and challenging cosmetic issue, which is often addressed by multiple modalities. A low-viscosity non-animal stabilized hyaluronic acid (NASHA) dermal filler, injected in microdoses into the mid-to-superficial dermis, may provide a useful new approach to improving the appearance of depressed acne scars MATERIALS AND METHODS: Twelve consecutive patients with moderate to severe acne scarring, who had completed a series of fractional laser resurfacing, underwent microinjections of 20 mg/mL hyaluronic acid (HA) gel into discrete depressed acne scars on the face RESULTS: Immediate visual improvement was observed in all lesions. The procedure was well tolerated. Adverse events were limited to transient pinpoint bleeding at the injection site CONCLUSION: Microinjection of low viscosity HA offers a valuable technique for the treatment of discrete depressed acne scars

Treatment of actinic keratoses and photodamage with non-contact fractional 1540-nm laser quasi-ablation: an ex vivo and clinical evaluation.

The main use of non-ablative fractional photothermolysis today is for the improvement of wrinkles and scars. The purpose of this work was to evaluate the effect of a "classic" non-ablative fractional 1540 nm on facial photodamaged skin and actinic keratoses. Seventeen patients with facial actinic keratoses (AKs) and photodamage underwent two or three laser treatments with fractional 1540-nm erbium glass laser at fluences of 75 mJ, 15 ms pulse duration, and 10-mm spot size in non-contact mode. Two blinded assessors and participants evaluated clinical improvement of treatment areas after 3 months, using a quartile grading scale (no improvement = 0, 1-25% improvement = 1, 26-50% = 2, 51-75% = 3, and 76-100% = 4). Three months after the last treatment, the mean level of improvement was 3.4 ± 0.72 for AK and 3.3 ± 0.54 for skin appearance. Adverse events observed after each treatment were moderate erythema, mild edema, erosions (two cases), and mild desquamation. No scarring or post-inflammatory pigmentary changes were observed. The clinical results were supported by histological changes observed in Yucatan pig studies in vivo and ex vivo. The 1540-nm fractional erbium glass laser in the non-contact mode is a safe and effective treatment for facial photodamage and AKs.

Hemangiomas of the nasal tip treated with propranolol.

BACKGROUND: Infantile hemangioma is the most common tumor of infancy. There are recent reports of the efficacy of propranolol in the treatment of these hemangiomas. Nasal tip hemangiomas pose a particularly sensitive concern aesthetically and functionally. The treatment of nasal tip hemangiomas is controversial. We assessed the effect of propranolol therapy in hemangiomas of the nasal tip. OBJECTIVES: To evaluate the response of nasal tip hemangiomas to systemic propranolol. METHODS: During 2008-2010 ten infant with nasal tip hemangiomas presented to our tertiary care center. All underwent comprehensive evaluation by a multidisciplinary team and were then treated with oral propranolol at 2 mg/kg/day, with continuous clinical follow-up until age 14-16 months, or in older infants until the proliferative phase resolved. RESULTS: Eight patients demonstrated good clinical improvement. Two patients had partial improvement. One patient discontinued treatment due to wheezing. Three patients had mild sleep disturbance which did not warrant discontinuation of treatment. No rebound was noticed after cessation of treatment. LIMITATIONS: Children presented by referral at variable ages. It is possible that routine initiation of propranolol in neonates at the first sign of nasal hemangioma may reduce the required treatment duration or dose. CONCLUSIONS: Early treatment of hemangiomas of the nasal tip with propranolol prevents lesion proliferation, reduces lesion volume, and prevents nasal and facial deformation. Propranolol appears to be a safe and effective treatment. Its efficacy and safety profiles, relative to other accepted therapies, suggest that it should be considered as the first-line treatment when intervention is required.

Low-fluence vs. standard fluence hair removal: a contralateral control non-inferiority study.

INTRODUCTION: Laser hair removal at lower fluences, delivered under certain conditions, may retain the efficacy of high-fluence lasers while improving tolerability. We performed a pilot study comparing the efficacy, safety and tolerability of laser hair removal using traditional settings compared to lower fluences, delivered from a larger handpiece and under vacuum. MATERIAL AND METHODS: Fourteen healthy participants underwent 5 axillary hair removal treatments with an 800 nm diode laser at 1-month intervals, with follow-up 1 and 3 months after the 5th treatment. In all patients, one side was treated with standard parameters using a 9×9 mm chilled tip and gel, while the contralateral side was treated using a 22×35 mm vacuum-assisted handpiece at fluences up to 12 J/cm(2). Follow-up assessments were performed after each treatment and at each follow-up visit, and included photography and questionnaires. RESULTS: Eleven participants completed the study and follow-up. All experienced significant hair removal in all treated areas. At the 3-month follow-up visit, the high-fluence and low-fluence treated axillae demonstrated comparable hair reduction. Participants found the lower fluence treatments to be more tolerable. No adverse events were reported. CONCLUSION: Lower fluence diode laser, delivered under conditions of vacuum and using larger spot sizes, can provide significant hair reduction.

Tattoo removal.

Over 50,000 new tattoos are placed each year in the United States. Studies estimate that 24% of American college students have tattoos and 10% of male American adults have a tattoo. The rising popularity of tattoos has spurred a corresponding increase in tattoo removal. Not all tattoos are placed intentionally or for aesthetic reasons though. Traumatic tattoos due to unintentional penetration of exogenous pigments can also occur, as well as the placement of medical tattoos to mark treatment boundaries, for example in radiation therapy. Protocols for tattoo removal have evolved over history. The first evidence of tattoo removal attempts was found in Egyptian mummies, dated to have lived 4,000 years BC. Ancient Greek writings describe tattoo removal with salt abrasion or with a paste containing cloves of white garlic mixed with Alexandrian cantharidin. With the advent of Q-switched lasers in the late 1960s, the outcomes of tattoo removal changed radically. In addition to their selective absorption by the pigment, the extremely short pulse duration of Q-switched lasers has made them the gold standard for tattoo removal.

Clinical results of skin remodeling using a novel pneumatic technology.

BACKGROUND: A myriad of technologies are available for the treatment of aging skin. These, however, still lack the ability to combine immediate, short-term and long-term aesthetic results with no downtime. Furthermore, the treatment of fine wrinkles on large surfaces remains challenging, as does the treatment of delicate regions, such as the dorsal hand, neck, and chest. OBJECTIVES: The aims of this study were to evaluate the short-term as well as the long-term efficacy and safety of a new skin remodeling device that pneumatically accelerates a jet of hyaluronic acid (HA) solution under high pressure into the dermis. METHODS: Thirty-four participants at three clinical sites underwent treatments with the Airgent device on the face, neck, chest, and dorsal hands for a total of 69 sites. Safety and efficacy were evaluated in short-term (1-3 months) and long-term follow-up (up to 18 months) by photography, by an independent reviewer and by participant self-evaluation. Histology was assessed before and 4 months after the third treatment. RESULTS: A total of 69 treatment areas were evaluable at 1-3 months follow-up. Photographic analysis demonstrated improvement in skin variables at all body sites treated. Treatment of the face and neck reduced the mean Fitzpatrick-Goldman Wrinkle Classification score by 39.4 and 30.4%, respectively, representing a full wrinkle class improvement. Treatments of the chest demonstrated significant visual improvement. Treatment of the dorsal hands produced good overall improvement (OI), with good improvement of protruding veins. Overall improvement increased with increasing number of treatments. A total of 56 treatment areas were evaluable for long-term follow-up. Treatment of the face and neck reduced the mean Fitzpatrick-Goldman Wrinkle Classification score by 27.6 and 21.2%, respectively. Improvement after treatment of the face represented a full wrinkle class reduction. Treatment of the chest and dorsal hands yielded significant visual improvement. Overall, 80% of subjects were satisfied with the treatment outcome and would recommend the treatment to friends and family. Histological analysis demonstrated increased dermal collagen ΙΙΙ. CONCLUSIONS: Pneumatic injection of HA under high pressure provides a safe, well-tolerated and effective method for improving the appearance of wrinkles on the face, neck, chest, and dorsal hands. Improvement can be seen as early as 1 month and as long as 18 months after treatment.

A novel fractional micro-plasma radio-frequency technology for the treatment of facial scars and rhytids: a pilot study.

INTRODUCTION: Fractional ablative and non-ablative lasers have gained popularity in the treatment of acne scars and rhytids due to their efficacy and improved tolerability. Plasma and radio frequency (RF) have also emerged as methods for ablative or non-ablative energy delivery. We report preliminary experience with a novel fractional micro-plasma RF device for the treatment of facial acne scars and rhytids. METHODS: Sixteen patients with facial acne scars or rhytids were treated at 4-week intervals. Treatment parameters were titrated to an immediate end point of moderate erythema. The clinical end point for cessation of treatment was the attainment of satisfactory clinical results. Results were monitored photographically up to 3 months after treatment. RESULTS: Acne scars showed marked improvement after two to four treatments. Facial rhytids demonstrated reduced depth after two treatments and marked improvement after four treatments. Treatment was well tolerated by all participants, with transient erythema and short downtime. These results provide initial evidence for the safety and effectiveness of fractional micro-plasma RF as a low-downtime and well-tolerated modality for the treatment of acne scars and facial rhytids.