Volume 10 | Issue 8
Tina Bhutani MD, Kristine B. Zitelli MD, John Koo MD|
Psoriasis is a chronic disease that exists in two phases: (1) the acute, flaring phase when psoriasis is highly inflamed, erythematous and pruritic and (2) the chronic, indolent phase after the acute manifestations are brought under control. Ideal therapies for psoriasis must focus on both of these phases. Therefore, a rapid and effective agent must be utilized to treat the acute phase, followed by safe long-term therapy for maintenance. This article proposes a new, effective sequential topical therapy for psoriasis using ongoing treatment with clobetasol (Clobex®) spray for one month followed by calcitriol (Vectical®) ointment for the next month. This strategy provides a highly effective, reliable and safe treatment option with minimal local and systemic adverse risks.
J Drugs Dermatol. 2011;10(8):831-834.
Malignancy Arising Within Cutaneous Tattoos: Case of Dermatofibrosarcoma Protuberans and Review of Literature
Kavitha K. Reddy MD,a C. William Hanke MD, MPH,b Emily P. Tierney MDa,b|
Background. Dermatofibrosarcoma protuberans (DFSP) is an uncommon tumor of the skin with high rates of local recurrence. Several reports describe a frequent history of local trauma. In one prior case, a DFSP arising in a tattoo site has been reported. Mohs micrographic surgery (MMS) has been used successfully for treatment.
Objective. To present a case of dermatofibrosarcoma protuberans arising in the site of a prior and current tattoo, and treated with Mohs micrographic surgery.
Methods. We present findings of a case of a DFSP arising in a tattoo and a review of Medline literature on the association between tattoos and cutaneous malignancy, and treatment of DFSP with MMS.
Results. Review of the literature confirms multiple reports of DFSP arising in sites of local trauma, as well as malignancies arising in sites of tattoos. The recurrence rate for MMS treatment of DFSP (0-6.6%) was found to be significantly lower than that for patients treated with wide local excision (13% to 95%).
Conclusions. DFSP should be considered in the differential diagnosis of neoplasms arising within areas of tattoos. Sites of local trauma and tattoos may show predilection for benign and malignant changes and should be evaluated during regular skin exams. Review of the literature confirms MMS is an ideal treatment modality for DFSP as the tumor often extends far beyond clinical margins.
J Drugs Dermatol. 2011;10(8):910-915.
Increased Prevalence of Psychiatric Disorders and Health Care-Associated Costs Among Patients With Moderate-to-Severe PsoriasisObjective: To characterize the prevalence of psychiatric disorders in patients with moderate-to-severe psoriasis and compare health care costs between patients with and without psychiatric comorbidities.
Methods: In a retrospective, matched case-control study, data for services from nearly 75 health care plans in the United States (U.S.) were collected from PharMetrics Patient Centric Database using International Classification of Diseases, Ninth Revision Clinical Modification codes, identifying a total of 39,855 adults with moderate-to-severe psoriasis (n=7,971) and without (controls; n=31,884). Patients with psoriasis had at least one psoriasis health care claim and received at least one medical/prescription treatment claim within two consecutive years. Psychiatric comorbidities and treatments among patients and controls were determined by claims. Annual inpatient, outpatient, emergency room, and prescription costs for those with and without psoriasis and those with and without psychiatric disorders were compared.
Results: Patients had significantly higher prevalence of anxiety (6.9% versus 4.4%), depression (9.2% versus 5.3%), bipolar disorder (1.1% versus 0.5%), or delirium (0.3% versus 0.1%; P<0.05) than controls (others P<0.0001). Significantly higher proportions of patients with psoriasis received antidepressants (6.1% versus 0.9%), anxiolytics (5.0% versus 0.8%), or antipsychotics (5.9% versus 0.9%) compared with controls (each P<0.0001). Total health care costs for patients with psoriasis (US $11, 369.47) were significantly higher than for controls ($3,427.60; P<0.001). Psoriasis patients with psychiatric disorders had significantly higher health care costs ($17,637.66) than those without psychiatric disorders ($10,362.80; P<0.001).
Conclusion: The prevalence of psychiatric disorders is higher in patients with moderate-to-severe psoriasis than in controls. Annual health care costs are higher in psoriasis patients with psychiatric disorders than in those without psychiatric disorders.
J Drugs Dermatol. 2011;10(8):843-850.
A Randomized, Double-Blind, Vehicle-Controlled Crossover Study to Determine the Anti-Pruritic Efficacy, Safety and Local Dermal Tolerability of a Topical Formulation (SRD174 Cream) of the Long-Acting Opiod Antagonist Nalmefene in Subjects With Atopic Dermatitis
Jo Lynne Herzog MD,a James A.Solomon MD PhD,b Zoe Draelos MD,c Alan Fleischer Jr. MD,d Dow Stough MD,e David I.Wolf MD,f William Abramovits MD,g William Werschler MD,h Emma Green BSc,i Maeve Duffy PhD,i Alan Rothaul PhD,i Robert Tansley MBBSi|
Objective: To investigate the efficacy, safety and tolerability of topical nalmefene (SRD174), a long acting opioid antagonist for the management of pruritus associated with atopic dermatitis (AD).
Design: Double-blind, vehicle-controlled, randomized, cross-over trial.
Setting: Eleven dermatology outpatient clinics in the U.S.
Patients: Sixty-two out of 136 screened adult subjects with confirmed AD affecting ≤20% of body surface area and with moderate-to-severe pruritus.
Interventions: SRD174 cream or matching vehicle cream applied as required during two 7-day periods separated by a wash-out period.
Main Outcome Measure(s): The primary efficacy variable was the period mean of the sum of pruritus intensity difference (SPID) from 0 to 4 hours (SPID0-4) where pruritus was measured on a 0-100 scale Visual Analog Scale (VAS) at seven pre-specified time-points following study drug application. A range of secondary efficacy, safety and tolerance endpoints were included.
Results: The LS means for the SPID0-4 (±SD) for SRD174 cream and Vehicle were 210.7 (20.4) and 212.1 (20.2), respectively (Difference = -1.3 (95% CI: -25.9, 23.3). None of the secondary efficacy endpoints tested demonstrated a statistically significant or clinically important difference between the test product and the vehicle. Overall, the SRD174 cream was well tolerated although there was a higher incidence of AEs when subjects took SRD174 cream (22, 36.7 percent of subjects) compared with when they were taking vehicle (14, 23.3 percent of subjects).
Conclusions: SRD174 cream did not demonstrate efficacy in the treatment of pruritus associated with atopic dermatitis raising questions on the role of peripheral opioid receptors as a target for the treatment of pruritus in this population. NCT00838708
J Drugs Dermatol. 2011;10(8):853-860.
A Retrospective Study to Investigate Racial and Ethnic Variations in the Treatment of Psoriasis With Etanercept
Objectives: Psoriasis is a chronic inflammatory condition that occurs worldwide; however, few studies have examined this condition in non-Caucasian populations. The purpose of this study was to investigate racial/ethnic differences in demographics, psoriasis severity, efficacy, safety, and health-related quality of life in patients treated with etanercept using data from the Etanercept Assessment of Safety and Effectiveness (EASE) in Psoriasis trial.
Patients and Methods: This is an investigator-initiated evaluation of data from the EASE study.
Results:The study included 2511 patients (Caucasian n=2164; Hispanic/Latino n=173; African American n=98; Asian n=76). Although baseline Physicians' Global Assessment (PGA) scores were similar, we found significant baseline differences in patient characteristics, prior therapy, percentage of body surface area (%BSA) affected and Dermatology Life Quality Index (DLQI) scores between the groups. At baseline, the Caucasian group had the longest disease duration (19 years), but the lowest percentage of BSA involvement (28%). The Asian group had the highest percentage of BSA involvement (41%). Baseline DLQI score was lowest for Caucasians (12.0) and highest for Hispanic/Latinos (14.6).
At week 12, response to therapy was similar in all ethnic/racial groups. The BSA involvement was reduced by more than 50 percent for all groups, but remained significantly higher for the Asian group (17%) than for the Caucasian (13%; P=0.0105) and African American groups (13%; P=0.0461).
At week 12, the mean Asian DLQI score of 5.2 was significantly higher (worse) than scores for the Caucasian (3.5; P=0.0001) and Hispanic/Latino groups (3.8; P=0.028). For both percentage of BSA and DLQI, differences among racial/ethnic groups in the percentage improvement from baseline were not statistically significant. Adverse event rates were similar for the groups.
Conclusions:Patient characteristics at enrollment differed among ethnic groups, but no significant racial/ethnic differences were found in safety or efficacy of etanercept. However, racial/ethnic differences in the impact of psoriasis on quality of life were observed.
J Drugs Dermatol. 2011;10(8):862-868.
Pedram Ghasri BS,a Brad A. Yentzer MD,a Tushar S. Dabade MD,a Steven R. Feldman MD, PhDa,b,c|
Background: Combination therapy is a common and appropriate treatment strategy for moderate-to-severe psoriasis, as it provides for enhanced efficacy and decreased toxicity compared to the use of a single agent. Acitretin is an effective oral retinoid for psoriasis that seems to find its greatest value when complemented by other topical and systemic treatments.
Objective: The primary aim of this study is to assess the use of acitretin in combination with other treatments for psoriasis.
Methods: We assessed the use of acitretin for the treatment of psoriasis using nationally representative survey data from the National Ambulatory Medical Care Survey (NAMCS).
Results: Among visits where acitretin was listed in the NAMCS, other psoriasis medications were co-prescribed in 62 percent of visits. The co-prescribed medications included topical corticosteroids (51%), calcipotriene (31%), biologics (6%), cyclosporine (5%), methotrexate (5%) and tazarotene (2%).
Conclusion: The use of acitretin in combination with other psoriasis treatments, particularly topical corticosteroids and calcipotriene, is a common practice. Acitretin is co-prescribed with the biologics, likely because of the relative lack of overlapping effects on immune function. The immune-sparing method of action of acitretin makes combination treatment with the systemic agents an attractive treatment option, especially in patients where further immunosuppression is unwarranted.
J Drugs Dermatol. 2011;10(8):876-880.
Topical Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Maintains Efficacy of Etanercept After Step-Down Dose in Patients With Moderate-to-Severe Plaque Psoriasis: Results of an Open Label TrialEtanercept is approved for the treatment of plaque psoriasis at a subcutaneous (SC) dosage of 50 mg twice-weekly for three months, followed by 50 mg SC once-weekly thereafter. It is of note, however, that many patients experience loss of efficacy when they step down to etanercept 50 mg/week, often instigating a switch to another biological. The current pilot study investigated the adjunctive use of a topical calcipotriene 0.005% and betamethasone dipropionate 0.064% combination ointment, approved for the treatment of psoriasis, to sustain the original efficacy of etanercept by augmenting response to the 50 mg/week SC dose, thus stabilizing the disease.
Trial Design: In this single-center, open-label study, subjects (n=20) underwent 12 weeks treatment with etanercept 100 mg/week (50 mg, 2x week; weeks –12 to -1), followed by etanercept 50 mg/week maintenance therapy for 40 weeks (weeks 0 to 40). Subjects were followed at four-week intervals. Starting at week 4, subjects who demonstrated an increase from baseline (week 0) body surface area (BSA) of >2% initiated therapy with calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment for four weeks. The study is limited by its small sample size, open-label nature, and lack of blinding.
Findings: Mean BSA involvement decreased significantly from week –12 to 0 with etanercept 50 mg twice a week. At week 4, on the etanercept 50 mg/week dose, mean BSA increased to 9.42±9.39 compared to week 0. With introduction of calcipotriene 0.005%/betamethasone dipropionate 0.064% ointment at week 4, mean BSA decreased to 4.62±8.19 by week 24 and was relatively stable for the remainder of the study period. Similarly, mean PASI (Psoriasis Area and Severity Index) scores improved from week -12 to week 0, increased at week 4, then decreased significantly by week 24 with adjunctive topical treatment.
Conclusion: Topical calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment is a safe and effective adjunct to etanercept 50 mg/week maintenance therapy.
J Drugs Dermatol. 2011;10(8):881-885.
Clobetasol Propionate 0.05% Spray for the Management of Moderate-to-Severe Plaque Psoriasis of the Scalp: Results From a Randomized Controlled Trial
Background: Clobetasol propionate 0.05% spray is available for treating moderate-to-severe plaque psoriasis; however, there is limited information with plaque psoriasis of the scalp.
Objective: Evaluate the efficacy, safety, and quality-of-life impact of clobetasol propionate 0.05% spray in patients with moderate to severe plaque psoriasis of the scalp.
Methods: Multicenter, randomized, double-blind, vehicle-controlled study involving 81 men and women with moderate-to-severe (Global Severity Score [GSS] = 3 or 4) plaque psoriasis of the scalp. Eligible patients were treated with clobetasol propionate 0.05% spray or vehicle spray, which was applied twice daily for up to four weeks. The primary efficacy end point was the GSS of psoriasis of the scalp after four weeks. Safety assessments included local tolerability, presence of Cushing's syndrome, and adverse events.
Results: At the end of treatment, 85 percent (35/41) of patients in the clobetasol propionate 0.05% spray group achieved success (GSS clear or almost clear), compared with 13 percent (5/40) in the vehicle spray group (P < .001). The proportion of patients treated with clobetasol propionate 0.05% spray who achieved a rating of clear (GSS = 0) after two weeks and at the end of treatment was 12 percent and 51 percent, respectively. Clobetasol propionate 0.05% spray was well tolerated, and there were no serious adverse events or reported cases of folliculitis or Cushing's syndrome.
Conclusion: Treatment with clobetasol propionate 0.05% spray for up to four weeks is effective and well tolerated for moderate-to-severe plaque psoriasis of the scalp.
J Drugs Dermatol. 2011;10(8):888-895.
An Open-label Study of the Safety and Efficacy of Sertaconazole Nitrate in the Treatment of Seborrheic Dermatitis
Boni E. Elewski MD and Wendy C. Cantrell CRNP|Objectives: To demonstrate the efficacy and evaluate the safety of sertaconazole nitrate cream 2% in the treatment of seborrheic dermatitis (SD).
Design: Single-center, open-label study.
Setting: One academic medical center.
Participants: Twenty adult male and female subjects aged 22 to 85 years (average, 56 years) with mild-to-severe seborrheic dermatitis of the face.
Measurements: The primary efficacy evaluation was the proportion of subjects with a score of 0 or 1 at the end of treatment (week 4) on the Investigator's Static Global Assessment scale. Secondary end points included percent change from baseline to week 4 in sum individual scores of erythema, scaling, induration, and pruritus at a preselected target lesion. Other end points included change in scores on Subject's Global Assessment scale and the Dermatology Life Quality Index.
Results: Success on the primary end point was achieved by 10 of 17 evaluable subjects (58.8%). Improvements in Investigator's Static Global Assessment score from baseline were statistically significant at each week. Significant improvements were also demonstrated in erythema, scaling, induration, and pruritus at week 4 compared to baseline. Improvement in Subject's Global Assessment scores compared to baseline were significant only at week 1 (P=0.031). Change in total mean SD Dermatology Life Quality Index scores from baseline to week 4 was 0.34 (± 0.62, P=0.039).
Conclusion: The results of this preliminary study support the efficacy and safety of sertaconazole nitrate cream, 2%, for the treatment of seborrheic dermatitis.
J Drugs Dermatol. 2011;10(8):898-902.
Assessor-Blinded Study of the Metabolic Syndrome and Surrogate Markers of Increased Cardiovascular Risk in Children With Moderate-to-Severe Psoriasis Compared With Age-Matched Population of Children With Warts
Eva M. Volf MD,a Danielle E. Levine MD,a Melissa A. Michelon MD,a Shiu-Chung Au MD,b Eshan Patvardhan MD,b Nicole Dumont,b Daniel S. Loo MD,b Jeffrey Kuvin MD,a,b Alice B. Gottlieb MD PhDa,b|
Adult patients with psoriasis have an increased prevalence of the metabolic syndrome (MetS) and cardiovascular disease (CVD) risk factors due to elevations of Tumor Necrosis Factor and other inflammatory cytokines.1,2 Recently, higher rates of hyperlipidemia, obesity, hypertension, and diabetes mellitus were seen in patients with juvenile psoriasis.3 Here, we report the interim results of an ongoing study of MetS and CVD risk factors in pediatric psoriasis patients.
J Drugs Dermatol. 2011;10(8):903-904.
Evaluation of Clinical Improvement in Acne Scars and Active Acne in Patients Treated With the 1540-nm Non-Ablative Fractional Laser
María José Isarría MD, Paloma Cornejo MD, Estefanía Muñoz BSc, Josefina Royo de la Torre MD, Javier Moreno Moraga MD|
Introduction. Acne is a characteristic condition of puberty; however, adults who continue to have acne outbreaks frequently attend dermatology clinics. Two conditions—active acne and residual scarring—often co-occur in these patients. The objective of the present study was to evaluate the improvement in scarring and active acne after treatment with a 1540-nm erbium: glass fractional laser.
Material and Methods. The authors treated 20 patients with acne and scarring. Each patient received panfacial treatment in four sessions with a 1-month interval between sessions. Patients, the treating physician and a blinded observer evaluated the results in four areas: improvement in scars, improvement in pores, improvement in acne, and improvement in sebum secretion. Improvements were graded using the Global Aesthetic Improvement Scale. The evaluation was made 12 weeks after treatment finished.
Results. Patients presented an improvement in both acne and scars. In 80 percent of cases, patients felt that the appearance of the scars had improved, and the improvement was classified as very much improved in 40 percent. In 85 percent of cases, patients felt that active acne had improved, and the improvement was classified as very much improved in 45 percent. Pore size was evaluated as improved by 75 percent of patients. Sebum secretion improved in 80 percent of cases.
Conclusion. A 1540-nm non-ablative fractional laser provides effective treatment of acne scars. Patient satisfaction is high and active acne lesions improve significantly. Treatment of this mixed condition (scarring and active acne) with a single device is reliable, with a favorable safety profile and a high degree of patient acceptance.
J Drugs Dermatol. 2011;10(8):916-921.
Mycobacterium Fortuitum Infection Following Adalimumab Treatment for Psoriasis and Subsequent Complication-Free Treatment With Alternate TNF-α Blockers
Michael B. Chang BS, Jennifer C. Sri MD, Marcia Driscoll MD, Anthony A. Gaspari MD|Tumor necrosis factor-α (TNF-α) inhibitors, such as adalimumab, are often used to treat psoriasis and psoriatic arthritis. While it is well known that these agents increase the risk of reactivation tuberculosis, recent evidence suggests that the risk of other nontuberculous mycobacterial (NTM) infections is on the rise. We report cutaneous Mycobacterium fortuitum in a 60-year-old woman with psoriasis who had been receiving adalimumab therapy for psoriatic arthritis for six months. No other risk factors were identified. M. fortuitum was cultured from a lesion on the right leg. Following resolution of the lesion, the patient has been successfully treated with infliximab infusions and subsequently certalizumab without complication for the past three years. To our knowledge, this is the first report of M. fortuitum occurring in a patient receiving adalimumab with successful subsequent treatment without complication while on another TNF-α inhibitor.
J Drugs Dermatol. 2011;10(8):927-929.
Central Serous Chorioretinopathy Associated With Topical Corticosteroids in a Patient With Psoriasis
Navid Ezra MD,a Mehran Taban MD,b Daniel Behroozan MDa,c,d|
Background: Central serous chorioretinopathy (CSC), also known as central serous retinopathy (CSR), is a visual impairment, often temporary, usually in a single eye, which mostly affects males in the age group of 20 to 50 but may also affect women. CSC occurring after prolonged use of topical steroids in a patient with psoriasis is a novel complication in the English literature.
Observations: We describe a case of a 25-year-old male, with a 15-year history of corticoid ointment use for psoriasis, who presented with loss of vision secondary to CSR.
Conclusions: All topical steroid treatments were discontinued and the patient recovered his vision completely. Although topical corticosteroids are frequently utilized for psoriasis management with a low rate of complication, clinicians should be familiar with this rare yet distressing condition. Furthermore, patients with increased production of endogenous corticosteroids (e.g., those with Cushing's syndrome, hypertension, or obstructive sleep apnea) should be warned of the potential of chorioretinopathy following prolonged use of topical corticosteroids
J Drugs Dermatol. 2011;10(8):930-933.
Nephrogenic systemic fibrosis (NSF) is a recently described systemic fibrosing disorder that develops in the setting of renal insufficiency. Exposure to gadolinium has been implicated in its development. While the primary manifestations are cutaneous, systemic fibrosis can also occur. Several anecdotal reports of successful treatment have been reported, but there is no consistently efficacious therapy. We report the improvement or stabilization of cutaneous disease in three patients with NSF using alefacept therapy. J Drugs Dermatol. 2011;10(8):922-924.
Cheryl Gray MD,a Sheila M. Greenlaw MD,a Christine Alavian MD,a Karen Wiss MDb|No abstract details for the moment.
Joanna Harp MD,a Joshua M. Schulman MD,a and Jack S. Resneck, Jr MDb|
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 University of California, San Francisco, School of Medicine, Dermatology Residency Program. 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 [email protected]
Deepti Gupta MD, Diana Camarillo MD, and Joshua M. Schulman MD|No abstract details for the moment.
No abstract details for the moment.
Winning Poster: A Phase 2, Open-Label, Investigator-Initiated Study to Evaluate the Safety and Efficacy of Apremilast in Subjects with Recalcitrant Contact or Atopic Dermatitis
Eva Volf MD|No abstract details for the moment.
News, Views and Reviews provides focused updates, topic reviews and editorials concerning the latest developments in dermatologic therapy.
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.
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.