Volume 11 | Issue 2
James M. Spencer MD|No abstract details for the moment.
Short-Term Combination Therapy and Long-Term Relapse Prevention in the Treatment of Severe Acne VulgarisFew long-term treatment regimens for severe acne vulgaris have been investigated in clinical trials. Data were combined from two consecutive, randomized, double-blind, controlled studies to evaluate the efficacy, safety and subject satisfaction of four nine-month regimens in severe acne vulgaris treatment. Subjects were first randomized to receive doxycycline (DCN) and adapalene 0.1% - benzoyl peroxide 2.5% (A/BPO) or vehicle once daily for 12 weeks. Subjects who had at least 50% global improvement were subsequently randomized to receive A/BPO or its vehicle once daily for 24 weeks. Over nine months, there were four regimens: A/BPO and DCN followed by A/BPO, vehicle and DCN followed by A/BPO, A/BPO and DCN followed by vehicle, and vehicle and DCN followed by vehicle. Among the four regimens, A/BPO and DCN followed by A/BPO led to the highest percentage of subjects rated "clear" or "almost clear" (50.0% vs. 40.4%, 26.2% and 25.0%, respectively), biggest reduction in total lesion counts (76% vs. 70%, 51% and 47%, respectively) and greatest subject satisfaction (85.0% vs. 75.5%, 63.3% and 52.4%, respectively) at week 36. It provided a faster onset of action compared to groups started with vehicle and DCN (P<.05 at week 2). Subjects receiving A/BPO and DCN followed by vehicle experienced deterioration once the active treatment was discontinued. All regimens were safe and well-tolerated. In conclusion, efficacious initial therapy and long-term treatment are both important. An initial combination therapy with adapalene-BPO and DCN followed by longer-term adapalene-BPO treatment is an efficacious and satisfactory new regimen for severe acne subjects.
J Drugs Dermatol. 2012;11(2):174-180.
Psoriasis is a complex, multigenic immune/inflammatory-mediated disorder that variably affects the skin, nails, and joints. In September 2009, ustekinumab (Stelara®), a monoclonal antibody that targets interleukin 12 (IL-12) and 23 (IL-23), was approved in the United States for treatment of moderate-to-severe plaque psoriasis. The drug's mechanism of action is derived from extensive immunologic and genomic research identifying IL-12 and IL-23 of the Th1 and Th17 inflammatory pathways, respectively, as key mediators of psoriasis. Ustekinumab is a completely human monoclonal antibody to the shared p40 subunit of IL-12 and IL-23. The drug has demonstrated efficacy, short-term safety, and convenience of use in the treatment of plaque psoriasis and psoriatic arthritis. Though long-term safety concerns remain, ustekinumab adds to the current treatment armamentarium and holds promise to improve quality of life. This is a concise and current review of ustekinumab in the treatment of plaque psoriasis and psoriatic arthritis, with focus on data from the seven published clinical trials.
J Drugs Dermatol. 2012;11(2):160-167.
Xiang Yang Han MD PhD,a Kurt Clement Sizer MD,a Hiok-Hee Tan MDb|
Background: A new leprosy-causing species, namely Mycobacterium lepromatosis, was discovered recently to be the cause of diffuse lepromatous leprosy (DLL) in Mexico. It is unknown whether this organism exists beyond Mexico.
Methods: We sought to determine the identity of the mycobacteria in the skin tissue of two patients from Singapore who died of DLL. DNA was extracted from archived biopsy tissue, and conserved polymerase chain reaction primers were used to amplify and sequence two to three mycobacterial genes in each skin sample.
Results: Both M. lepromatosis and the well-known leprosy agent Mycobacterium leprae were identified in each DLL skin sample. The M. lepromatosis gene sequences from the Singapore cases matched 99.9% with the known Mexican M. lepromatosis strain, but they only matched the corresponding M. leprae sequences by 89.2%.
Conclusions: The new species M. lepromatosis exists beyond Mexico and is the cause of DLL in Singapore. It may cause dual infections along with M. leprae in endemic areas. Archived skin biopsy can be used to differentiate the leprosy agents.
J Drugs Dermatol. 2012;11(2):168-172.
Transepidermal Water Loss (TEWL) and Corneometry With Hydrogel Vehicle in the Treatment of Atopic Dermatitis: A Randomized, Investigator-Blind Pilot Study
Leon H. Kircik MD|
Disruption of the epidermal barrier, as indicated by a reduction in skin hydration and an increase in transepidermal water loss (TEWL) is a feature of atopic dermatitis (AD). Novel formulations of dermatologic therapies may enhance patient satisfaction and adherence and may possibly preserve and enhance epidermal barrier function. A single-center, investigator-blinded, randomized, split-body exploratory study was undertaken to assess the hydrating and barrier preserving effects of a water-based hydrogel vehicle. Subjects (n=20) with mild to moderate disease at baseline applied hydrogel vehicle or a moisturizing lotion (Eucerin Lotion®, Beiersdorf, Inc.) in a split-body fashion for two weeks. Corneometry and TEWL measurements were taken at baseline and week 2. Hydrogel vehicle produced a statistically significant improvement in skin hydration from baseline, as compared to a moisturizing lotion control. Hydrogel produced no statistically significant change in TEWL, while comparator lotion increased TEWL. Data from this pilot study indicate that the water-based hydrogel vehicle improves skin hydration and does not further impair epidermal barrier function, suggesting that it is an appropriate vehicle choice for patients with mild-to-moderate atopic dermatitis.
J Drugs Dermatol. 2012;11(2):180-184.
Bilateral Axilla Hair Removal Comparing a Single Wavelength Alexandrite Laser With Combined Multiplexed Alexandrite and Nd:YAG Laser Treatment From a Single Laser PlatformBackground/Objectives: This study compares the efficacy, safety, and side-effect profile of three different firing modes in a single laser emitting both dual-wavelength multiplexed laser pulses and single-wavelength pulses for removing unwanted axillary hair in subjects with Fitzpatrick skin types II-V.
Methods: Subjects received four laser treatments at 4-6 week intervals. One axilla was treated with the alexandrite laser alone while the contralateral axilla was treated with multiplexed pulses delivering either a 755 nm/1064 nm pulse or a 1064 nm/755 nm pulse. Efficacy was evaluated through blinded hair counts performed on digital photographs taken two and six months following the final treatment.
Results: Mean hair clearance percentages were 83%, 81%, and 86% for the alexandrite, alexandrite/YAG sequence, and YAG/alexandrite sequence, respectively. Side effects were minimal and did not differ by treatment.
Conclusion: Muliplexed 755 nm/1064 nm and 1,064 nm/755 nm pulses compared favorably with the 755 nm pulses for efficacy and side-effect profile, all being highly efficacious. Further study of the multiplexed pulses in various clinical settings, including refractory hair removal, are indicated.
J Drugs Dermatol. 2012;11(2):185-190.
Vasanop Vachiramon MD,a,b Trudy Brown LEI CLS CPE,a,c Amy J. McMichael MDa|Background: Laser hair removal (LHR) is increasingly popular for the treatment of unwanted hair. To date, there have been few studies to evaluate patient satisfaction and complications after LHR among people of color.
Objectives: To determine patient satisfaction and complications with long-pulsed Nd:YAG laser assisted hair removal in dark-complexioned skin individuals from the patient's point of view.
Patients/Methods: A survey questionnaire was administered to subjects with Fitzpatrick skin type VI between the ages of 21-70 years who had been treated with long-pulsed Nd:YAG for unwanted hair. Questions were comprised of those related to satisfaction and complications from treatment with LHR. Satisfaction was recorded on a linear analogue scale (LAS=not at all satisfied; 100=extremely satisfied).
Results: Fifty patients (female 41, male 9) completed the survey. All patients were satisfied with Nd:YAG LHR treatment with the mean satisfaction score of 84.2. All patients favor LHR treatment as compared to alternative methods. The majority of patients (79.3%) who had completed six or more LHR treatments were removing their hair less frequently than before LHR treatment. Hyperpigmentation after treatment was noted in three patients (6%), which lasted for 3-10 days. No hypopigmentation, blistering, or scarring was observed. All patients completing the study would recommend LHR for patients with unwanted hair with the mean recommendation score of 91.5.
Conclusions: Nd:YAG laser-assisted hair removal gives a high rate of patient satisfaction in terms of hair reduction with minimal complication among subjects of color.
J Drugs Dermatol. 2012;11(2):191-195.
A Randomized, Prospective Trial Evaluating Surgeon Preference in Selection of Absorbable Suture MaterialThis study is the first double-blinded, randomized comparison of two absorbable sutures. To better understand product characteristics and surgeon preference, we conducted a study of two similar-appearing FDA-approved sutures, glyconate and poliglecaprone 25. Four dermatologic surgeons were enlisted. A total of 48 patients with 53 surgical sites were examined. One half of each surgical wound was closed with one type of suture and the other half with the other type. Each half was evaluated for product characteristics. There was no statistically significant difference in surgeon preference for glyconate versus poliglecaprone 25 (P=0.64). Of the cohort preferring poliglecaprone 25, there was a correlation with speed of closure (P=0.06). Of the surgeons that preferred glyconate, we found significantly better visibility (P=0.03), reduced suture breakage during knot tying (P=0.05), and correlation with better handling properties (P=0.06) associated with that preference. The data from this study will enable products to be designed towards these needs and allow surgeons to select sutures that more precisely fit their particular requirements.
J Drugs Dermatol. 2012;11(2):196-201.
Background: Facial lipoatrophy is one of the most distressing manifestation for HIV patients. It can be stigmatizing, severely affecting quality of life and self-esteem, and it may result in reduced antiretroviral adherence. Several filling techniques have been proposed in facial wasting restoration, with different outcomes. The aim of this study is to present a triangular area that is useful to fill in facial wasting rehabilitation.
Methods: Twenty-eight HIV patients rehabilitated for facial wasting were enrolled in this study. Sixteen were rehabilitated with a non- resorbable filler and twelve with structural fat graft harvested from lipohypertrophied areas. A photographic pre-operative and post- operative evaluation was performed by the patients and by two plastic surgeons who were “blinded.” The filled area, in both patients rehabilitated with structural fat grafts or non-resorbable filler, was a triangular area of depression identified between the nasolabial fold, the malar arch, and the line that connects these two anatomical landmarks.
Results: The cosmetic result was evaluated after three months after the last filling procedure in the non-resorbable filler group and after three months post-surgery in the structural fat graft group. The mean patient satisfaction score was 8.7 as assessed with a visual analogue scale. The mean score for blinded evaluators was 7.6.
Conclusion: In this study the authors describe a triangular area of the face, between the nasolabial fold, the malar arch, and the line that connects these two anatomical landmarks, where a good aesthetic facial restoration in HIV patients with facial wasting may be achieved regardless of which filling technique is used.
J Drugs Dermatol 2012;11(2):202-208.
Efficacy and Tolerability Assessment of a Topical Formulation Containing Copper Sulfate and Hypericum perforatum on Patients With Herpes Skin Lesions: A Comparative, Randomized Controlled TrialBackground: Topical Acyclovir has moderate efficacy on recurrent HSV symptoms, requiring repeat applications for several days. Topical Dynamiclear, which requires only a single dose application, may provide a more effective and convenient treatment option for symptomatic management of HSV.
Objectives: The study assessed the comparative efficacy and tolerability of a single use, topical formulation containing copper sulfate pentahydrate and Hypericum perforatum that is marketed as Dynamiclear™ to a topical 5% Acyclovir cream standard preparation and use.
Methods: A prospective, randomized, multi-centered, comparative, open-label clinical study was conducted. A total of 149 participants between 18 and 55 years of age with active HSV-1 and HSV-2 lesions were recruited for the 14-day clinical trial. Participants were randomized into two groups: A (n=61), those receiving the Dynamiclear formulation, and B (n=59), those receiving 5% Acyclovir. Efficacy parameters were assessed via physical examination at baseline (day 1), day 2, 3, 8, and 14. Laboratory safety tests were conducted at baseline and on day 14.
Results: Use of the Dynamiclear formulation was found to have no significant adverse effects and was well tolerated by participants. All hematological and biochemical markers were within normal range for the Dynamiclear group. Statistically, odds for being affected by burning and stinging sensation were 1.9 times greater in the Acyclovir group in comparison to the Dynamiclear group. Similarly, the odds of being affected by symptoms of acute pain, erythema and vesiculation were 1.8, 2.4, and 4.4 times higher in the Acyclovir group in comparison to the Dynamiclear group.
Conclusions: The Dynamiclear formulation was well tolerated, and efficacy was demonstrated in a number of measured parameters, which are helpful in the symptomatic management of HSV-1 and HSV-2 lesions in adult patients. Remarkably, the effects seen from this product came from a single application.
J Drugs Dermatol. 2012;11(2):209-215.
Comparison of Four Botulinum Neurotoxin Type A Preparations in the Treatment of Hyperdynamic Forehead Lines in Men: A Pilot Study
Background:Botulinum neurotoxin type A (BTXA) offers a minimally invasive approach for the treatment of facial rhytides and has been well accepted by male patients. However, few comparative studies about the efficacy of the different BTXA preparations in this emerging group of patients are available.
Objective: To access the efficacy of four BTXA preparations in the treatment of hyperdynamic forehead lines in men.
Methods: Twelve male patients with a mean age of 30.5±5.26 years, with moderate or severe hyperdynamic forehead lines on a facial wrinkle scale (FWS), were involved in the study. Using an intra-individual controlled study design, either 17 mouse units (m.U) of Botox, Prosigne, and Xeomin or 51 Speywood units (s.U) of Dysport were applied to each side of a patient´s forehead. Subjects with absent or mild forehead lines were considered responders. Study evaluations were performed monthly up to day 150.
Results: All patients responded in a side-to-side evaluation and no asymmetries or differences in the degree of reduction of hyperdynamic forehead lines were noted at day 30 and day 60 ( P =0.340). Analysis of all combined forehead sides treated with a given BTXA did not show statistically significant differences in terms of maintenance of improvement between different BTXA preparations at day 150 ( P =0.528).
Conclusion: The data obtained in this study revealed a similar effectiveness of the BTXA preparations evaluated in the treatment of hyperdynamic forehead lines in men, when considering a dose-ratio of 1 m.U of Botox, Xeomin or Prosigne to 3 s.U of Dysport.
J Drugs Dermatol. 2012;11(2):216-219.
Topical "anti-aging" products, with their seemingly limitless list of ingredients, make extensive claims to reduce wrinkles, fine lines, and sun damage, among others. Sales in the United States alone for cosmeceutical products are expected to increase by 7.4% per year to $8.2 billion by 2012. However, in this enormous industry, there has been a significant lack of rigorous controlled trials of efficacy. It is difficult for both dermatologists and consumers to make informed decisions in a market that is yet to be clearly defined and regulated. We elucidate the scientific basis for, as well as the literature behind, common active ingredients found in products intended to reverse photoaging, discuss some interesting new activities, and provide a review of several comprehensive studies on over-the-counter (OTC) products.
J Drugs Dermatol. 2012;11(2):220-224.
Background: Surgical reconstruction of defects on the lower half of the nose mandates special considerations. Simple excision and suturing might cause a depressed scar and nostril flaring. Hence, the preoperative plan should be designed properly to avoid disfigurement and to achieve a successful reconstruction.
Objective: Three basic reconstructive concepts are essentially combined: 1.) The ratio between scar length and defect diameter should be extended beyond the standard 3:1 ratio; 2.) The defect should be positioned asymmetrically within the inferior half of the excision outline; and 3.) Para-median defects mandate an inferior, horizontal advancement (”sliding”) flap to avoid nostril flaring. A salvage technique is also discussed.
Methods: Data from patients treated by Mohs micrographic surgery for tumors of the inferior aspect of the nasal dorsum and reconstructed according to the proposed course of action was collected and reviewed.
Results: The proposed reconstructive path proved successful for all patients. Although one case required salvage skin grafting, all patients had aesthetically pleasing results. No postoperative complications were noted.
Conclusions: Simple excision and primary suturing is a viable method for treating lesions on the lower half of the nose, provided that the surgeon follows a set of basic reconstructive principles.
J Drugs Dermatol. 2012;11(2):226-228.
Background: Bullous pemphigoid (BP) is an acquired, autoimmune, sub-epidermal blistering disease. The incidence of both BP and internal malignancy increases with age, yet the relationship between BP and malignancy has been a matter of debate for many years. Numerous cases have been published that link BP with various internal malignancies. While some analyses of large sets of clinical data fail to show a statistically significant correlation between BP and internal malignancy, others imply that there is a measurable correlation.
Observation: We report a case of a 71-year-old male with invasive squamous cell carcinoma of the left heel and renal cell carcinoma who presented with urticarial bullous pemphigoid.
Conclusions: There are few case reports in the literature associating bullous pemphigoid and renal cell carcinoma or squamous cell carcinoma. To our knowledge, this is the first reported case of coincident renal cell carcinoma, squamous cell carcinoma and urticarial BP. This case further supports investigation for underlying malignancy in patients with BP, particularly in the elderly.
J Drugs Dermatol. 2012;11(2):234-238.
Here we present the first case of a patient from Ottawa Canada, presenting with leprosy-like illness associated with Mycobacterium lepromatosis. The patient had no history of travel to leprosy-endemic areas or any obvious risk factors. Clinically, the patient presented with an anesthetic maculopapular rash on the trunk, back, and extremities. A skin biopsy of a lesion revealed a dermal lymphohistiocytic infiltration involving the vessels with an inflammatory process extending to the nerves. A neurological exam also identified a severe sensorimotor polyneuropathy. Concurrently, the patient was diagnosed with non-resectable, non small cell carcinoma of the lung, further complicating his clinical presentation. A Kinyoun stain of nasal blows and a Fite stain of the skin biopsy revealed few to moderate acid fast bacilli respectively. Cultures of the skin biopsy and multiple nasal blows were negative. Molecular studies of a skin biopsy sample including sequence analysis of a 765 bp region of the 16s rRNA gene eventually identified the organism with 100% homology to M. lepromatosis. The patient was treated for leprosy and appeared to improve slightly on therapy but died as a result of his malignancy approximately five months after the initiation of therapy. This represents the first case of a patient with M. lepromatosis like illness outside of Mexico and Singapore.
J Drugs Dermatol. 2012;11(2):229-233.
Fixed drug eruptions often have a characteristic appearance, which, when correlated with the clinical history, can be easily identified. However, multifocal fixed drug eruptions, especially the non-pigmenting variety, can present a diagnostic challenge, especially in the absence of a complete medication history. We present such a case, in which the patient was taking two over-the-counter medications, both of which contain uncommon causes of multifocal fixed drug eruptions.
J Drugs Dermatol. 2012;11(2):244-246.
Acitretin, a metabolite of the aromatic retinoid etretinate, has been utilized successfully in the treatment of psoriasis since the late 1980s. Of the oral retinoids available, etretinate and acitretin are the most likely agents to induce various dose-dependent hair changes, but to our knowledge this is the first reported case of acitretin-induced poliosis. Additional cutaneous findings included skin atrophy and stickiness. Here we report a case of full body acitretin-induced poliosis with concurrent alopecia in a patient with psoriasis. A proposed mechanism for the poliosis is also presented here. Closer examination of retinoid-induced hair changes is needed in order to help physicians better counsel their patients regarding the adverse effects of acitretin and to expand the current knowledge on hair follicle biology.
J Drugs Dermatol. 2012;11(2):247-249.
Neurothekeoma is a rare neoplasm assigned to the broad category of benign peripheral nerve sheath tumors. Its cell of origin is still unknown, but most ultrastructural and immunohistochemical studies have favoured the Schwann cell perineurium or fibroblast. Neurothekeoma most commonly presents in females, especially in the second and third decades of life. Typically it presents as an asymptomatic solitary, firm, flesh-coloured or hyperpigmented slow-growing papule or nodule that involves the skin and superficial subcutis. It usually involves the face, neck, arm or shoulder but can also involve extracutaneous sites. Neurothekeoma occurs in myxoid (classic), cellular and intermediate (mixed) variants. Here, we report a 45-year-old male patient presenting with a nodule on the nose that was found to be a myxoid variant of neurothekeoma. It was treated with a simple shave excision followed by removal of the lobulated deeper part by forceps. He had no recurrence after tthree years of follow-up. To the best of our knowledge, this is the first case of a myxoid neurothekeoma of the nose to be reported in the Middle East.
J Drugs Dermatol. 2012;11(2):252-255.
The authors report a female patient with recalcitrant ulcerated necrobiosis lipoidica (NL) that was resistant to numerous systemic agents and who responded to treatment with intravenous immunoglobulin (IVIG), leading to resolution of the ulcerated areas for several months. Subsequent treatment with two further courses of IVIG was less effective, but a course of intravenous methylprednisolone led to regression of the lesions. As well as briefly reviewing the literature on treatments used to treat ulcerated NL, we outline the pathological mechanisms thought to be involved in the condition and how the modes of action of IVIG might explain its apparent efficacy in this case. As far as we are aware, the response of ulcerated NL to IVIG or methylprednisolone has not been reported previously, although other systemic preparations of corticosteroids have been used.
J Drugs Dermatol. 2012;11(2):256-259.
Paclitaxel-Associated Subungual Pyogenic Granuloma: Report in a Patient With Breast Cancer Receiving Paclitaxel and Review of Drug-Induced Pyogenic Granulomas Adjacent to and Beneath the Nail
Subungual and periungual pyogenic granuloma occur in association with certain systemic medications. Paclitaxel is an antitumor drug of the taxane family used in the management of breast cancer. Taxanes have many associated nail changes that may occur in patients receiving either docetaxel or paclitaxel for systemic chemotherapy. The nail changes in a 68-year-old woman with metastatic breast cancer who presented for nail changes after receiving 12 cycles of weekly paclitaxel are described herein: nail plate red-brown discoloration, onycholysis with leukonychia, proximal subungual hemorrhage, and subungual pyogenic granuloma. The literature on systemic medications associated with the development of subungual and periungual pyogenic granulomas is reviewed; drugs associated with the development of pyogenic granuloma at the locations include antineoplastics, antiretrovirals, epidermal growth factor receptor inhibitors, immunosuppressants and retinoids. In conclusion, subungual pyogenic granuloma can occur not only in patients receiving docetaxel, but also in patients treated with paclitaxel. And, paclitaxel should be included in the list of drugs associated with the occurrence of subungual pyogenic granuloma
J Drugs Dermatol. 2012;11(2):262-268.
Resident Rounds is a section of the JDD dedicated to highlighting various dermatology departments with residency training programs. Resident Rounds includes three sections: (1) a program spotlight, highlighting pertinent information about the department and residency training program; (2) a section presenting study materials used by residents at the program; and (3) a section designed to highlight recent interesting cases seen at the institution. This issue of Resident Rounds features the Georgia Health Sciences University. The editor of Resident Rounds is Omar A. Ibrahimi MD PhD. He is currently the Director of Cutaneous Laser and Cosmetic Surgery and a Mohs surgeon at the University of Connecticut. Dr. Ibrahimi is also a Visiting Scientist at the Wellman Center for Photomedicine at Massachusetts General Hospital/Harvard Medical School. If you are interested in highlighting your training program in a future issue, please contact Dr. Ibrahimi at OIbrahimi@jddonline.com.
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Jason Chouake BS and Adam Friedman MD|No abstract details for the moment.
Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.
Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.