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P6905A new aluminum sesquichlorhydrate topical foam for the treatment ofaxillary and/or palmar primary hyperhidrosis: A preliminary report
Giuseppe Micali, MD, Dermatology Clinic, University of Catania, Catania, Italy;Aurora Tedeschi, MD, PhD, Dermatology Clinic, University of Catania, Catania,Italy; Francesco Lacarrubba, MD, Dermatology Clinic, University of Catania,Catania, Italy; Marianna Umana, MD, Dermatology Clinic, University of Catania,Catania, Italy; Paola Di Mauro, MS, Dermatology Clinic, University of Catania,Catania, Italy
Primary hyperhidrosis is a disorder characterized by excessive eccrine sweat glandproduction, beyond physiologic needs, that primarily involves the axillae as well aspalms and soles. Because primary hyperhidrosis may have a profound effect onpatient’s quality of life, it requires an effective, proven therapeutic approach.Common first-line treatment consists of topical formulations containing aluminumsalts that act by physically blocking eccrine sweat gland ducts; a limitation of thesecompounds are the lack of clinical trials able to establish their real efficacy and thefrequent onset of burning and stinging. The aim of this open study was to evaluatethe efficacy and tolerability of a new aluminum sesquichloridrate, propellant-free,topical foam in a series of patients affected by primary hyperhidrosis. Tenconsecutive subjects (3M/7F, mean age 34.6 years) affected by primary hyperhidro-sis (6 axillary, 4 palmar) were enrolled in a open label study. Exclusion criteria werethe presence of secondary hyperhidrosis, allergy or sensitivity to aluminum salts,and previous topical and/or systemic therapy for hyperhidrosis (# 3 monthsbefore). The foam was applied once daily for 4 weeks. Clinical evaluations wereperformed at days 0, 7, 14, and 28. Efficacy was assessed by means of Minor test (adiagnostic test used to calculate the amount of sweat) and DLQI (Dermatology LifeQuality Index). Each axilla and palm was subdivided into 4 areas for Minor testreactivity, each area scoring from 0 to 3 (0 ¼ negative, 1 ¼ mildly, 2 ¼ moderatelypositive, 3¼ intensely positive). Therefore, the possible total score ranged from 0 to12. Local tolerability was evaluated by physicians assessing itching, burning, andskin irritation, using a 4-point score (from 0: no symptoms to 3: severe symptoms).After 4 weeks, Minor test mean score value decreased from 7.1 to 4.05 (43.7%reduction), and DLQI mean value decreased from 11.5 to 7.6 (34% reduction).Statistical analysis is in progress. No skin irritation and/or other side effects wereobserved during the study. This new propellant-free foam appears to be a promisingtopical treatment in reducing sweating in patients with mild to moderate axillaryand palmar primary hyperhidrosis. Additional studies are warranted to evaluate thesafety and tolerability of this new formulation in a bigger samples and in a long-termtreatment.
AB40
cial support: None identified.
CommerP6661A novel hidradenitis suppurativa efficacy variable, HiSCR (hidradenitissuppurativa clinical response), is responsive to change with adalimumabtherapy: Results of a phase II study
Alexandra B. Kimball, MD, MPH, Harvard Medical School, Boston, MA, UnitedStates; David A. Williams, MD, MPH, Abbott Laboratories, Abbott Park, IL, UnitedStates; Gregor B. E. Jemec, MD, Department of Dermatology, Roskilde Hospital,Health Sciences Faculty, University of Copenhagen, Roskilde, Denmark; YihuaGu, MS, Abbott Laboratories, Abbott Park, IL, United States
Background: Hidradenitis suppurativa (HS) is a painful, chronic inflammatory skindisease characterized by recurrent inflamed nodules, abscesses, and fistulas. Apaucity of practical efficacy variables to detect clinically relevant response totherapy impedes clinical research in HS. We report development of a novel endpoint(Hidradenitis Suppurativa Clinical Response [HiSCR], defined as $ 50% reductionfrom baseline in total abscess and inflammatory nodule [AN] count, with no increasein counts for abscesses and draining fistulas) and its efficacy results, in retrospectivecomparison with efficacy results for the primary endpoint (HidradenitisSuppurativa-Physician Global Assessment [HS-PGA]�based Clinical Response, de-fined as HS-PGA score of clear, minimal, or mild with a $ 2-grade improvement frombaseline) in the double-blind, placebo-controlled phase of a 52-week study ofadalimumab (ADA).
Methods: Moderate to severe HS patients (HS-PGA of $ 3) were randomized 1:1:1 toplacebo (pbo; n¼ 51), ADA 40mg every other week after 80mg atWeek 0 (eow; n¼52), or ADA 40 mg every week after 160 mg at week 0 and 80 mg at week 2 (ew; n¼51). The primary efficacy endpoint was percentage of patients achieving HS-PGA�based Clinical Response at week 16. Efficacy was also retrospectivelyevaluated using HiSCR, analyzed in a patient subpopulation with baseline AN count$ 3 and draining fistula count # 20.
Results: Baseline painwas substantial; 13% of patients used opioids. At weeks 12 and16, respectively, HS-PGA�based Clinical Response rates for the pbo, eow, and ewgroups were 5.9%, 7.7%, and 21.6% (eow vs pbo, P¼.721; ew vs pbo, P¼.020) and3.9%, 9.6%, and 17.6% (eow vs pbo, P ¼.252; ew vs pbo, P ¼.025). With the HiSCRefficacy variable, response rates at weeks 12 and 16, respectively, for the pbo, eow,and ew groups were 16.3%, 35.6%, and 59.1% (eow vs pbo, P¼.042; ew vs pbo, P\.001) and 25.6%, 33.3%, and 54.5% (eow vs pbo, P ¼ .437; ew vs pbo, P ¼ .007).
Conclusion: This phase II, dose-ranging study demonstrated evidence of ADAefficacy in moderate to severe HS patients, with statistically significant treatmentdifferences for ADA ew versus pbo in both HS-PGA�based Clinical Response andHiSCR at both week 12 and week 16. HiSCR appears more responsive to change andbetter able to discriminate improvement in eow-treated patients than HS-PGA�based Clinical Response and may be a useful new tool to assess the efficacyof HS therapies in clinical practice and research trials.
y and poster are supported by Abbott Laboratories.
This studJ AM ACAD DERMATOL
P6715A rare presentation of a pilomatrixoma: A bullous variant
Ketaki Bhate, MBBS, Department of Dermatology, Nottingham, United Kingdom;Rabi Nambi, MBBS, Derby Hospitals Foundation Trust, Derby, United Kingdom
A pilomatrixoma is a benign, most commonly solitary, slow growing adnexal tumorwith a predilection towards hair matrix. They can be sporadic or inherited asautosomal dominant. Associations with Myotonic dystrophy, Turner syndrome, andRubinsteineTaybi syndrome have been reported. Pilomatrixomas are common;however, the bullous presentation is rare and has not been commonly reported. Wereport the case of a 17-year-old male with a 6-month history of a cystic swelling onthe left lateral aspect of his upper arm. The lesion was asymptomatic and there wasno history of previous trauma. The lesion was initially incised by the generalpractitioner; despite this, the lesion enlarged. He was otherwise fit and well with nosignificant medical history. There was no family history of a similar lesion. Onexamination, a 3-cm 3 4-cm ill-defined, fluid filled, flaccid blister with a centralcraggy nodule was noted. Arophic striae were seen at the edges. Histologically, therewas proliferation of blood vessels with basophils, shadow cells, an inflammatoryinfiltrate, and prominent lymphatic vessels. These findings were consistent with abullous pilomatrixoma. Complete excision was curative. Including this case, therehave been a total of 17 cases of this rare bullous pilomatrixoma variant. The peak ageof presentation is between 10 and 20 years and there is clear female preponderance.Most cases are found on the shoulder or upper arm, but there are some reports ofcases found on the trunk, neck, or scalp. Most cases are of tumors between 1 and 3cm in size, but they can extend up to 6 cm. b-Cantenin is integral in pathogenesisand not only has a structural function but is also involved in cell signaling.Histologically, most cases are of a multilobulated tumor, with individual tumorlobules showing shadow cells and basophilic cells surrounded by a fibrous capsule.Dilated lymphatic vessels and lymphodema in the dermis are commonly seen in thebullous variant and form the histologic distinguishing feature from the commontype. Other features include dilated blood vessels as seen in our case, calcification,altered collagen architecture, and necrosis. Malignant transformation is rare, and theprognosis is good with no recurrences noted. Obstruction to the drainage oflymphatic fluid by the underlying nodule and mechanical irritation have beenproposed as theories for this atypical presentation. Complete excision is ourrecommended treatment.
cial support: None identified.
CommerP6593A rare variant of Sweet syndrome: A consequence of adalimumab therapy?
Manju Paul, Mid Staffordshire NHS Foundation Trust, Cannock, United Kingdom;Anne Ward, Mid Staffordshire NHS Foundation Trust, Cannock, United Kingdom;Stephen Harris, Mid Staffordshire NHS Foundation Trust, Stafford, UnitedKingdom
Case report: A 53-year-old woman with rheumatoid arthritis developed an intermit-tent itchy urticarial type rash in 2008 within a month of starting adalimumab. Therash worsened during the summer of 2011, becoming persistent but not sympto-matic. She was systemically well. Rheumatoid arthritis was under good control withadalimumab. Her other medicationsweremethotrexate, folic acid, paracetamol, andnaproxen. Dermatologic examination revealed multiple erythematous papules andnodules predominantly on the upper arms and thighs with minimal involvement ofthe trunk. Histopathologic examination showed a normal epidermis. In the dermis,there was a patchy infiltrate of cells with open vesicular nuclei and pale cytoplasmadmixed with a few scattered lymphocytes particularly around blood vessels. Thesecells appear to dissect between collagen bundles and extended to subcutaneous fat.On immunocytochemistry these cells were positive with LCA, CD68, myeloperox-idase, CD14, weak calprotectin and low proliferation indexwith Ki67. This indicatescells of myeloid/histiocytic origin. Extensive investigations ruled out a hematologicmalignancy. A final diagnosis of monocytic/histiocytic Sweet syndrome was made.
Discussion: Sweet syndrome was first described by Robert Douglas Sweet in 1964.Patients typically develop a sudden onset of tender, erythematous, cutaneousplaques and nodules accompanied by fever, leukocytosis, and neutrophilia. Themain histologic feature of Sweet syndrome is a dermal infiltrate of neutrophils inlesions without evidence of vasculitis. However, unusual clinical and histopatho-logic features have been reported. One of the unusual histologic variants ishistiocytic Sweet syndrome. The presence of histiocytes may indicate early diseaseor relation to a drug. The trigger for development of Sweet syndrome is not clear inour patient. AntieTNF-a agents have been used successfully on many occasions totreat disorders with major neutrophilic dysfunction, including pyoderma gangre-nosum and Sweet syndrome. However, more recently, there have been a few reportsof Sweet syndrome occurring soon after starting adalimumab, suggesting thatantieTNF-a agents may paradoxically potentiate neutrophilic dysfunction inpredisposed persons. because there is a surge in the number of patients takingadalimumab, treating clinicians should be aware of this rare possibility.
cial support: None identified.
CommerAPRIL 2013
