Ashy dermatosis: Treatment with clofazimine

(Poster reference number 4870)Teresa Pinto-Almeida, MD, Centro Hospitalar do Porto - Hospital de SantoAnt�onio, Dermatology Department, Porto, Portugal; Manuela Selores, MD,Centro Hospitalar do Porto - Hospital de Santo Ant�onio, DermatologyDepartment, Porto, Portugal; M�onica Caetano, MD, Centro Hospitalar do Porto- Hospital de Santo Ant�onio, Dermatology Department, Porto, Portugal; Ros�arioAlves, MD, Centro Hospitalar do Porto - Hospital de Santo Ant�onio, DermatologyDepartment, Porto, Portugal

Background: Ashy dermatosis, or erythema dyschromicum perstans, is a raredermatosis characterized by ash-gray patches symmetrically distributed over thetrunk and extremities. Its etiology is still unknown, but an abnormality in cell-mediated immunity is thought to play a role, due to the involvement of cell-adhesionand activation molecules in its pathogenesis.

Case report: We report the case of a 46-year-old white man that presented with a 1-year history of gray-bluish-coloured asymptomatic macules, with an active erythem-atous border, gradually expanding over the trunk and upper thighs. His medicalhistory was unremarkable and he was on no regular medication. Complete bloodcount, chemistry profile, urinalysis, VDRL and viral serology (HBV, HCV, and HIV)were within the normal range or negative. Patch tests with the standard allergenswere also negative. Histologic examination of a skin biopsy showed featuresconsistent with the diagnosis of ashy dermatosis. Treatment with clofazimine 100mg qd was initiated. This was continued for 3 months and then reduced for 100 mgevery other day, for another three months. A significant improvement was achieved,with progressive clearing of the gray macules and no new lesions appearing. After 6months of follow-up, the patient remains free of lesions.

Discussion: Therapeutic options for Ashy dermatosis are numerous, includingcorticosteroids, isoniazide, griseofulvin, keratolytics, antihistamines, chloroquineand dapsone, with variable results. Treatment with clofazimine has been attemptednot only for its cosmetic effect, producing a uniform coloring of the skin that masksthe pigmented areas, but also because it’s beneficial effect may be mediated byantiinflammatory and immunomodulatory actions. This report supports the thera-peutic efficacy of clofazimine in the treatment of ashy dermatosis.

APRIL 20

cial support: None identified.

Commer

Baseline methotrexate does not impact the incidence of infliximabinfusion reactions: Results from a Canadian real-world treatment registry

(Poster reference number 5161)Wayne Gulliver, MD, Memorial University of Newfoundland, St. John’s, NL,Canada; Francois Nantel, PhD, Merck Canada Inc, Kirkland, QC, Canada; WarrenWinkelman, MD, PhD, Merck Canada, Inc, Kirkland, QC, Canada

Objectives: Systemic immunosuppressive agents administered at the start of, andconcurrently with infliximab (IFX) therapy are believed to help mitigate theoccurrence of infusion reactions. The aim of the present analysis is to determine towhat degree baseline methotrexate (MTX) use is associated with the incidence rateof infusion reactions.

Method: RemiTRAC infusion is a Canadian prospective observational safety registryfocusing on IFX infusions across all indications. The majority of subjects (47%) hadrheumatoid arthritis (RA), with 10% plaque psoriasis, 5% psoriatic arthritis (PsA),13% Crohn disease, 17% ankylosing spondylitis, and 4% ulcerative colitis. In the2010 data analysis, 1070 subjects had been enrolled since registry inception in 2005.A total of 13,114 infusions were recorded, with a mean of 12.4 6 9.7 infusions persubject, representing 1662.73 patient-years of exposure.

Results: Only 251/13,114 infusions were complicated by an infusion reaction(1.9%), nearly all mild or moderate in severity (236/251 or 94%). Infusion reaction(IR) incidence rates across indications were fairly similar: For example, 0.7% for PsA,2.3% for RA, 1.8% for psoriasis, and 1.4% for Crohn disease. Concomitant MTX use atbaseline was reported for 16% of psoriasis patients as opposed to 77% of RA and 50%of PsA. 2.0% of all infusionswith baseline MTX on board had been complicated by anIR, compared to 1.8% of infusions without baseline MTX (P ¼ .4427). Conclusions:Although the unit of analysis of this ‘‘real-life setting’’ registry is the infusion, thuslimiting the generalizability of these observations, baseline MTX immunosuppres-sive therapy appears to have little to no influence on the incidence of IFX infusionreactions. The mechanism is unknown but suggests that most infusion reactionsmight be nonimmunogenic in nature. Further study is warranted, particularly withmore infusions in the setting of plaque psoriasis.

cial support: 100% is sponsored by Merck Canada, Inc.

Commer

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Cortexolone 17a-propionate: Preclinical profile of a new topical, skinselective, steroidal antiandrogen

(Poster reference number 5024)Giuseppe Celasco, MD, Cosmo Research & Development S.p.A., Lainate, Italy;Daniel Piacquadio, MD, Therapeutics, Inc, San Diego, CA, United States; LuigiMoro, PhD, Cosmo S.p.A., Lainate, Italy

Cortexolone 17a-propionate (CB-03-01, Cosmo SpA, Lainate, Italy) is a new steroidalantiandrogen proposed for topical treatment of androgen-dependent skin disorderssuch as acne, seborrhoea, and androgenetic alopecia. The properties of this newmoiety have been evaluated in a variety of animal models. The results of thesenonclinical studies demonstrate CB-03-01 has potent antiandrogenic activity with-out material systemic effects. The pharmacologic properties and non-clinicalassessment of this new active pharmaceutical ingredient will be presented. In brief,in a hamster’s flank organ test, the topical activity of CB-03-01 was 2-4 times greaterthan that of finasteride, flutamide and progesterone, and almost equivalent to that ofcyproterone acetate. In addition to its antiandrogenic activity, CB-03-01 also has mildantiinflammatory properties. CB-03-01 competes at the human androgen-receptorlevel, but it does not inhibit the 5a-reductase in reconstructed human epidermis.After daily subcutaneous administration in rat, CB-03-01 is devoid of systemicantiandrogenic, antianabolic, and glucocorticoid activities and it does not inhibitgonadotropin hypersecretion nor compete with rat pituitary GnRH receptor. Inhuman skin, in rat skin homogenates, and in human plasma, CB-03-01 is quicklymetabolized to the inactive parent cortexolone so that the expected systemicbioavailability of unchanged steroid after topical application should be very low. Inacute toxicity studies in mouse and in rat, the LD50 was greater than 100 and 1000mg/kg body weight, after intravenous and subcutaneous administration respec-tively. In repeated subcutaneous and dermal toxicities performed in rat and in rabbit,CB-03-01 was shown to be well tolerated up to the maximum tested dose of 50mg/kg body wt. Safety pharmacology including standard receptor binding, hERG-Kchannel inhibition, cardiac toxicity in dog, behavior Irwin test, and CYP450(induction/inhibition) did not show any alerting signals. CB-03-01 was not amutagen in Ames test, in human chromosomal aberration test, and it was not askin sensitizer agent in the guinea-pig. CB-03-01 was not teratogenic in rat and rabbitup to subcutaneous doses of 25 and 1.5 mg/kg respectively. Based on these pre-clinical data, CB-03-01 should be considered an antiandrogen suitable for advance-ment into human trials.

cial support: Fully supported equally by Cosmo S.p.A. andeuticals.

Commer IntrepidPharmac

Delusions of parasitosis: World perspective on the choice ofpsychopharmacotherapy

(Poster reference number 5266)Misha Heller, University of Southern California, Keck School of Medicine, LosAngeles, CA, United States; Eric Lee, MD, University of Nebraska Medical Center,College of Medicine, Omaha, NE, United States; Faranak Kamangar, University ofCalifornia, Davis, School of Medicine, Sacramento, CA, United States; JennyMurase, MD, Palo Alto Foundation Medical Group, Department of Dermatologyand University of California, San Francisco, Department of Dermatology,Mountain View, CA, United States; John Koo, MD, University of California, SanFrancisco, Department of Dermatology, San Francisco, CA, United States; KellyPark, MD, University of California, San Francisco, Department of Dermatology,San Francisco, CA, United States; Tina Bhutani, MD, University of California, SanFrancisco, Department of Dermatology, San Francisco, CA, United States

Background: Patients suffering from delusions of parasitosis (DOP) have a fixed,false belief that they are infected with parasites or other organisms. As much as 90%of DOP patients seek help from dermatologists. Although it would be ideal for DOPpatients to be managed by psychiatrists who have expertise in managing psychiatricmedications, patients are often unwilling to go to psychiatrists because they refuseto acknowledge the underlying psychiatric nature of their condition. The mostdefinitive intervention a dermatologist can offer DOP patients is to prescribe themantipsychotic agents.

Objective: Dermatologists from all parts of the world were surveyed to gain aworldwide perspective on the preferred antipsychotic agent for the treatment ofDOP.

Methods: A 9-question survey was developed to assess the use of psychopharma-cologic agents in the treatment of DOP. The survey asked participants to indicatewhichmedications they considered to be 1st- and 2nd-line therapy for DOPandwhy,how many DOP patients they have treated with these medications, and if patientshave experienced any side effects from these medications. Surveys were distributedto physicians in attendance at the 22nd World Congress of Dermatology in Seoul,Korea in May 2011. Surveys were given at two psychodermatology sessions: (1) theJoint Meeting of the European Society of Dermatology and Psychiatry, Associationfor Psychocutaneous Medicine of North-America, and Japanese Society ofPsychosomatic Dermatology; and (2) the Pyschosomatic DermatologySymposium. Only dermatologists with experience in treating DOP were asked tocomplete the survey. Out of the approximately 100 physicians in attendance, a totalof 43 dermatologists met these criteria.

Results: Pimozide (19), followed by risperidone (10), haloperidol (7), olanzapine(4), and then antidepressants (3) were indicated to be the preferred first-linetherapies for DOP. Details regarding side effects observed and number of patientstreated will be provided in the poster.

Discussion: Our findings suggest that there are several effective and safe psycho-pharmacologic agents now available beyond pimozide to treat DOP. However,pimozide, by a significant margin, still appears to be the preferred first-lineantipsychotic agent for DOP.

cial support: None identified.

Commer

J AM ACAD DERMATOL AB171