Vein imaging laser reduces bruising in bruise-prone botulinum toxin injected patients.

BACKGROUND: Injection-related bruising is a common complication of many injectable treatments including facial injections of botulinum toxin (BTX) for aesthetic use. OBJECTIVE: We have investigated the use of a vein imaging laser (VIL) to observe otherwise non-visible subcutaneous blood vessels in 40 patients who had a history of bruising with past BTX injections to the face during the previous 12 months. METHODS: Over a 4-month period 40 patients, who previously had developed bruising after injectable BTX to the face, were treated with further BTX to the same areas as previously, but using a VIL during the injections. Patients were evaluated for their severity of bruising. RESULTS: 40 patients out of 2400 patients had experienced bruising with a severity score total of 92 (mean per patient 2.3) with BTX injections before VIL use. On injection using the VIL 6 of the 40 patients had bruising with severity score total of 7 (mean 1.16). CONCLUSION: The use of a VIL significantly reduced the frequency and severity of bruising associated with BTX injections.

Light-emitting diode 415 nm in the treatment of inflammatory acne: an open-label, multicentric, pilot investigation.

BACKGROUND: The management of acne remains a challenge, with current therapies linked to significant side effects and patient non-compliance. Phototherapy using blue light has been proven in the treatment of acne vulgaris and offers the clinician an effective alternative. OBJECTIVE: To determine the effect of narrowband light-emitting diode (LED) blue light in the reduction of inflammatory and non-inflammatory lesions in patients with mild to moderate acne and to evaluate patient tolerance of the therapy. METHODS: Forty-five patients were treated with high-intensity pure blue light, 415 nm and 48 J/cm2, receiving two treatments of 20 minutes per week for a period of 4-8 weeks. Clinical assessment was performed at baseline, and 2, 4 and 8 weeks after treatment. A patient's therapeutic response was measured using a global improvement scoring system. RESULTS: The mean improvement score was 3.14 at 4 weeks and 2.90 at 8 weeks. Nine patients experienced complete clearing at 8 weeks. The treatment was well tolerated, with 50% of patients highly satisfied with the treatment. CONCLUSION: This open-label study suggests the therapeutic efficacy of high-intensity LED pure blue light in the treatment of acne vulgaris with no reported side effects.

Dispelling the myth: appropriate use of poly-L-lactic acid and clinical considerations.

OBJECTIVES: Injectable poly-L-lactic acid (PLLA; Sculptra) is widely used throughout Europe and the USA to restore volume in depressed areas of the face by stimulating neocollagenesis. Injectable PLLA was previously marketed as New-Fill, which was often injected incorrectly and at too high a concentration, resulting in some physicians losing confidence in this product. Today, Sculptra is still regarded with a degree of scepticism by some physicians, due to direct or indirect experience with New-Fill. Sculptra, both in formulation and use, is vastly superior to New-Fill and clinical experience with this product dispels the myths associated with the earlier types of injectable PLLA. RESULTS: PLLA is a very safe, biodegradable compound that has been used in a wide range of medical devices for the last 30 years. In injectable form a good safety profile has been proven; however, when the device is overconcentrated, localized overstimulation of the fibroblasts can result in the formation of small lumps (subcutaneous papules), which are non-pathological but nevertheless palpable by the patient. Physicians must also be trained in the injection of this device, as incorrect injection technique can cause device-related adverse events. CONCLUSION: New product guidelines have ensured that problems with PLLA concentration have been countered, and tried and tested injection techniques have been shown to ameliorate device-related adverse events, both of which are dispelling the myths associated with modern injectable PLLA.

An overview of ultraviolet radiation, sunscreens, and photo-induced dermatoses.

The incidence of sunlight-induced skin aging and skin cancers, particularly melanoma skin cancer, has been increasing in many parts of the world. Authorities are recommending primary prevention programs to reduce cutaneous photodamage and skin carcinogenesis. An integral component of these programs is the use of protective clothing and effective sunscreens. Most modern sunscreens have highly efficient absorption or reflecting capabilities throughout ultraviolet B, partly ultraviolet A, and in some instances infrared wavelengths. Over the last several years, more efficient sunscreening ingredients have been developed for improved skin protection. More recently, direct evidence has demonstrated the effectiveness of sunscreens in their ability to reduce the incidence of solar keratoses. This article reviews the protectiveness of sunscreens and assays that predict their levels of protection.

Adverse reactions to dermal fillers: a review of European experiences.

BACKGROUND: In Europe, numerous dermal fillers have been utilized for the past decade. A lot of drawbacks have been reported and sometimes, severe complications occurred. OBJECTIVE: Our purpose is to report the clinical aspects of the adverse reactions following injections of some of the dermal fillers. Histological aspects of complications are also described. RESULTS: Adverse reactions secondary to biodegradable products are usually time limited, but with the non-biodegradable products, we have observed severe, persistent, and recurrent complications. Histological examinations, in cases of non-biodegradable products, may show the presence and persistence of the filler. CONCLUSION: For the moment, there is no ideal dermal filler. All fillers can lead to adverse events and we need to inform patients fully before injecting. Clinical studies with long-term follow-up before launching a new product on the market are recommended. We believe that in Europe, at present, the CE mark is not a guarantee of safety of dermal fillers.

Psoriasis: immunopathogenesis and evolving immunomodulators and systemic therapies; U.S. experiences.

BACKGROUND: Psoriasis is a chronic inflammatory skin disorder that is presently without a permanent cure. Up to 40% of patients with psoriasis also develop psoriatic arthritis. The mainstay armamentarium to treat psoriasis systemically includes methotrexate, cyclosporin and oral retinoids, all with significant potential for toxicity and the need for close laboratory supervision. The although the exact mechanism of psoriasis is still unclear, the involvement of T-cell-mediated cytokine expression in the aetiology of psoriasis is becoming clearer. The goal of modern treatment is to target such immune responses that lead to the formation of psoriatic plaques and psoriatic arthritis using selective immunomodulating pharmacotherapy. The advantages of these biological agents are less toxic systemic side-effect profiles that will improve the quality of life in psoriatic patients. OBJECTIVES: This review article describes current and emerging selective immunotherapies and systemic therapies for the treatment of psoriasis, and will briefly discuss disease immunopathogenesis. METHODS: Literature review. RESULTS AND CONCLUSIONS: Given the role of the inflammatory immune responses in the pathogenesis of psoriasis, the goal of modern medicine and pharmacotherapy lies in the design and use of specific targets in cell-mediated immune reactions and the modulation of the expression of various inflammatory cytokines. The clinical evidence of efficacy of some of these new biological immunomodulatory agents from several U.S.-based research studies and clinical experiences is convincing.

Topical photodynamic therapy in clinical dermatology.

The growing incidence of cutaneous malignancies each year necessitates the development of new and more effective methods for both the diagnosis and the treatment of cancerous lesions, while assuring better cosmetic results and improving patient satisfaction. With that in mind, the use of topical photodynamic therapy (PDT) has been explored in the treatment as well as the diagnosis of various cutaneous malignancies. Using the intrinsic cellular haem biosynthetic pathway and principles of photoillumination, topical PDT carries the goal of selectively targeting abnormal cells, while preserving the normal surrounding structures. This paper will discuss the various applications and data on the use of topical PDT in dermatology.

A review of peripheral nerve blockade as local anaesthesia in the treatment of palmar hyperhidrosis.

Injection of botulinum toxin type A (BTX-A) is an effective method of controlling palmar hyperhidrosis. It is, however, an uncomfortable procedure without adequate anaesthesia. We outline the techniques used, the reasons for them and potential pitfalls that can be avoided, with an outline of the neural anatomy relevant to the palmar injection of BTX-A. We have been using peripheral nerve blockade as local anaesthesia during BTX-A treatment of palmar hyperhidrosis for the last few years, and have found it an effective method of providing pain relief during the procedure, giving greater anaesthesia than that given by topical anaesthetic cream under occlusion and ice. It has been our experience that patients prefer wrist blockade to topical anaesthesia and ice when receiving BTX-A injections for treatment of palmar hyperhidrosis.

Botulinum toxin type a is a safe and effective treatment for axillary hyperhidrosis over 16 months: a prospective study.

OBJECTIVE: To evaluate the safety and efficacy of botulinum toxin type A (BTX-A) (BOTOX) over 16 months in the treatment of bilateral primary axillary hyperhidrosis. DESIGN: A 16-month study with initial double-blind randomization to 50 U of BTX-A or placebo per axilla. After 4 months, participants could receive up to 3 further treatments with open-label BTX-A over 12 months. SETTING: Fourteen dermatology or neurology clinics in Germany, Belgium, and the United Kingdom. PARTICIPANTS: Of 207 individuals aged between 17 and 74 years who had persistent bilateral primary axillary hyperhidrosis that interfered with daily activities, 174 (84%) completed the study. The baseline gravimetric assessment was a spontaneous sweat production of 50 mg or greater in each axilla prior to initial treatment. MAIN OUTCOME MEASURES: At week 4 after each treatment, the response rate of subjects who had at least a 50% reduction from baseline in axillary sweating, as measured by gravimetric assessment, was evaluated. Adverse events were spontaneously reported throughout the study, together with quality-of-life parameters and assessment of neutralizing antibodies to BTX-A. RESULTS: Over the 16-month period, 356 BTX-A treatments were given to 207 subjects. After placebo treatment, the response rate at week 4 was 34.7%. After the first, second, and third treatment with BTX-A, response rates at week 4 were 96.1%, 91.1%, and 83.3%, respectively. For subjects receiving more than 1 treatment, the mean duration between BTX-A treatments was approximately 7 months; however, 28% of subjects completed the study after only 1 BTX-A treatment. Subjects' satisfaction after treatments was consistently high, their quality of life improved, and there was a reduction in the impact of the disease on their lives. The safety profile of BTX-A after repeated treatments was excellent and no confirmed positive results for neutralizing antibodies to BTX-A occurred. CONCLUSION: Repeated intradermal injections of BTX-A over 16 months for treatment of primary axillary hyperhidrosis is safe and efficacious.

Effect of botulinum toxin type A on quality of life measures in patients with excessive axillary sweating: a randomized controlled trial.

BACKGROUND: Botulinum toxin type A (BTX-A) has been shown to be a safe and effective treatment for primary focal hyperhidrosis. However, the effect of BTX-A therapy on quality of life (QOL) in patients with this condition has only recently begun to be studied in controlled clinical trials. OBJECTIVES: To assess the impact on QOL of BTX-A treatment in patients with bilateral primary axillary hyperhidrosis. METHODS: A multicentre, randomized, double-blind, placebo-controlled trial enrolled 320 patients who exhibited persistent, bilateral, primary axillary hyperhidrosis sufficient to interfere with daily activities. These patients were treated with either 50 U BTX-A (Botox, Allergan, Inc., Irvine, CA, U.S.A.) or placebo in each axilla. QOL was assessed using the Hyperhidrosis Impact Questionnaire (HHIQ) at baseline and 1, 4, 8, 12 and 16 weeks post-treatment, as well as the Medical Outcomes Trust Short Form-12 Health Survey(SF-12) at baseline and 16 weeks post-treatment. RESULTS: At baseline, participants reported a marked negative impact of hyperhidrosis on various measures, including emotional status, ability to participate in daily and social activities, productivity at work and number of clothing changes per day. During the post-treatment period, statistically and clinically significantly greater improvements in all of these parameters were observed for the BTX-A group compared with the placebo group (P < 0.01). The BTX-A group improvements were observed within 1 week of treatment, and were sustained with little or no decline throughout the 16-week follow-up period. Compared with the baseline HHIQ responses regarding treatment history, BTX-A treatment resulted in a greater level of overall treatment satisfaction than did many other hyperhidrosis treatments. In addition, patients treated with BTX-A exhibited statistically significantly greater improvement in the physical component summary score of the SF-12 at 16 weeks than did placebo-treated patients (P < or = 0.019). CONCLUSIONS: Hyperhidrosis is associated with a substantial QOL burden; however, QOL is markedly improved with BTX-A treatment.

Etanercept for severe psoriasis and psoriatic arthritis: observations on combination therapy.

BACKGROUND: The antitumour necrosis factor (TNF) activity of etanercept has been utilized to generate an important and novel treatment for rheumatoid arthritis. TNF has also been implicated in the pathogenesis of psoriasis. OBJECTIVES: To determine whether blockade of TNF activity by etanercept may provide an additional treatment option for patients with psoriasis. METHODS: In an uncontrolled trial, etanercept was added to the treatment regimen in six patients with severe recalcitrant psoriasis (three also with psoriatic arthritis) partially resistant to other ongoing systemic agents. RESULTS: In each case, the disease activity showed marked improvement on addition of etanercept therapy. No added toxicity was found with etanercept. CONCLUSIONS: Etanercept appears to be a promising immunomodulatory agent that can be used in combination therapy for the treatment of psoriasis, and a prospective controlled trial may be warranted.

Tazarotene cream for the treatment of facial photodamage: a multicenter, investigator-masked, randomized, vehicle-controlled, parallel comparison of 0.01%, 0.025%, 0.05%, and 0.1% tazarotene creams with 0.05% tretinoin emollient cream applied once daily for 24 weeks.

OBJECTIVE: To assess the safety and efficacy of 4 concentrations of tazarotene cream in the treatment of facial photodamage. DESIGN: Prospective weekly multicenter, investigator-masked, randomized, parallel-group study. SETTING: University hospitals and clinical research centers. PATIENTS: Three hundred forty-nine subjects with facial photodamage. INTERVENTION: Daily topical application of tazarotene cream (0.01%, 0.025%, 0.05%, and 0.1%) compared with its vehicle and with 0.05% tretinoin emollient cream. RESULTS: Tazarotene cream and tretinoin cream significantly improved mottled hyperpigmentation and fine wrinkles. At week 24, treatment success rates based on global responses were 67% (39 of 58 subjects) with 0.1% tazarotene, 52% (30 of 58 subjects) with 0.05% tazarotene, 36% (21 of 58 subjects) with 0.025% tazarotene, 41% (24 of 59 subjects) with 0.01% tazarotene, 55% (32 of 58 subjects) with 0.05% tretinoin, and 22% (13 of 58 subjects) with vehicle. Local adverse events, although more frequent with tazarotene at higher concentrations, were generally mild to moderate. CONCLUSIONS: Tazarotene in a cream formulation is safe and is associated with positive changes in the treatment of photodamaged facial skin.

Hyaluronic acid skin fillers: adverse reactions and skin testing.

BACKGROUND: Hyaluronic acid (HA) fillers have been proposed as alternatives to other temporary skin fillers, such as bovine collagen, for treating facial skin lines and for providing lip augmentation. Several types of commercial HA fillers are now available in many countries. They include Restylane, which is produced by microbiologic engineering techniques, and Hylaform, which is HA extract derived from rooster combs. They have been approved for use in several countries, but not currently in the United States. There are no recommendations to perform pretreatment skin testing by the manufacturers. OBJECTIVE: Our purpose is to describe and comment on our experiences with Hylaform and Restylane fillers. Observation of any side effects and skin testing results were documented. METHODS: Between September 1996 and September 2000, 709 patients were treated with Hylaform and Restylane and were followed up clinically for at least 1 year. Three of these patients (0.42%) developed delayed skin reactions. Three other patients were referred for evaluation of their skin reactions from other practitioners. Five of these 6 patients agreed to skin testing of their forearms. RESULTS: In the 5 patients tested, challenge intradermal skin testing was positive in 4 patients; the reactions started approximately 8 weeks after injection. CONCLUSIONS: There was a slight incidence of delayed inflammatory skin reactions to two HA fillers. Both of these reactions occurred after the first and repeat injections. Challenge skin testing was positive in 4 of 5 tested patients.

Botulinum toxin type A in treatment of bilateral primary axillary hyperhidrosis: randomised, parallel group, double blind, placebo controlled trial.

OBJECTIVES: To evaluate the safety and efficacy of botulinum toxin type A in the treatment of bilateral primary axillary hyperhidrosis. DESIGN: Multicentre, randomised, parallel group, placebo controlled trial. SETTING: 17 dermatology and neurology clinics in Belgium, Germany, Switzerland, and the United Kingdom. PARTICIPANTS: Patients aged 18-75 years with bilateral primary axillary hyperhidrosis sufficient to interfere with daily living. 465 were screened, 320 randomised, and 307 completed the study. INTERVENTIONS: Patients received either botulinum toxin type A (Botox) 50 U per axilla or placebo by 10-15 intradermal injections evenly distributed within the hyperhydrotic area of each axilla, defined by Minor's iodine starch test. MAIN OUTCOME MEASURES: Percentage of responders (patients with >/=50% reduction from baseline of spontaneous axillary sweat production) at four weeks, patients' global assessment of treatment satisfaction score, and adverse events. RESULTS: At four weeks, 94% (227) of the botulinum toxin type A group had responded compared with 36% (28) of the placebo group. By week 16, response rates were 82% (198) and 21% (16), respectively. The results for all other measures of efficacy were significantly better in the botulinum toxin group than the placebo group. Significantly higher patient satisfaction was reported in the botulinum toxin type A group than the placebo group (3.3 v 0.8, P<0.001 at 4 weeks). Adverse events were reported by only 27 patients (11%) in the botulinum toxin group and four (5%) in the placebo group (P>0.05). CONCLUSION: Botulinum toxin type A is a safe and effective treatment for primary axillary hyperhidrosis and produces high levels of patient satisfaction.

A randomized trial of the efficacy of a new micronized formulation versus a standard formulation of isotretinoin in patients with severe recalcitrant nodular acne.

BACKGROUND: Isotretinoin is very frequently the drug of choice for the management of severe recalcitrant nodular acne. Recently, a new micronized and more bioavailable formulation of isotretinoin has been developed that permits once-daily administration in lower doses than usually used with standard isotretinoin (Accutane), regardless of whether it is taken with or without food. OBJECTIVE: Our purpose was to determine whether micronized isotretinoin and standard isotretinoin are clinically equivalent. METHODS: In this multicenter, double-blind, double-dummy study, 600 patients with severe recalcitrant nodular acne were treated with either 0.4 mg/kg of micronized isotretinoin once daily without food (n = 300) or 1.0 mg/kg per day of standard isotretinoin in two divided doses with food (n = 300). Lesion counts were monitored over 20 weeks. RESULTS: Both treatment groups in this well-controlled clinical trial experienced an equivalent reduction in the number of total nodules (facial plus truncal). In addition, an equivalent proportion of patients achieved 90% clearance of the total number of nodules. Both formulations had similar results for other efficacy variables. CONCLUSION: Once-daily use of the micronized and more bioavailable formulation of isotretinoin under fasted conditions is clinically equivalent to the standard twice-daily formulation under fed conditions in the treatment of severe recalcitrant nodular acne.

Safety of a new micronized formulation of isotretinoin in patients with severe recalcitrant nodular acne: A randomized trial comparing micronized isotretinoin with standard isotretinoin.

BACKGROUND: Isotretinoin is a very effective drug for treating severe recalcitrant nodular acne. A new micronized formulation of isotretinoin has been shown to be clinically equivalent to standard isotretinoin with improved bioavailability and minimal food effect. The safety profile of the micronized formulation has not been described previously. OBJECTIVE: The objective of this article is to report the incidence and intensity of adverse events found in a comparative, double-blind efficacy study that showed clinical equivalence of the new micronized formulation of isotretinoin and the standard isotretinoin formulation (Accutane). METHODS: Six hundred patients with severe recalcitrant nodular acne were treated with micronized isotretinoin (n = 300) under fasted conditions or standard isotretinoin (n = 300) under fed conditions. One cohort received single daily doses of 0.4 mg/kg of micronized isotretinoin without food and the other cohort received 1.0 mg/kg per day of standard isotretinoin in two divided doses with food. Adverse events were monitored during 20 weeks of drug therapy. RESULTS: The proportion of adverse events in most body systems was generally lower in patients receiving micronized isotretinoin than in those receiving standard isotretinoin. CONCLUSION: Micronized isotretinoin appears to have a safety profile similar to that of standard isotretinoin and to carry a lower risk of mucocutaneous events and hypertriglyceridemia.

Tazarotene plus UVB phototherapy in the treatment of psoriasis.

BACKGROUND: The addition of oral retinoids to phototherapy may accelerate and enhance antipsoriatic efficacy, but can result in systemic adverse events and additional laboratory monitoring costs. OBJECTIVE: Our purpose was to determine whether the topical addition of tazarotene to UVB phototherapy improves efficacy without problems related to photosensitivity. METHODS: Bilateral target plaques were randomized to receive two of the following, one on each plaque once daily for 14 days: tazarotene 0.1% gel, vehicle gel, or no treatment. Thereafter, the same treatments were continued 3 times per week, plus UVB phototherapy 3 times per week, for an additional 67 days. RESULTS: Tazarotene plus UVB phototherapy achieved faster and significantly greater reductions in plaque elevation and scaling throughout treatment and achieved at least 50% improvement from the pretreatment baseline with a significantly lower median cumulative UVB exposure than vehicle gel plus UVB light or UVB phototherapy alone. No case of unusual photosensitivity was noted in the tazarotene plus UVB treatment group. CONCLUSION: The addition of tazarotene to UVB phototherapy improves and accelerates efficacy and maintains acceptable safety and tolerability.