Medicine (St Vincent's) - Research Publications

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    Once-Daily Roflumilast Foam 0.3% Improves Severity and Burden of Itch in Patients With Scalp and Body Psoriasis in a Randomized, Double-blind, Vehicle-Controlled Phase 2b Study
    Moore, A ; Alonso-Llamazares, J ; Bhatia, N ; Devani, A ; Bukhalo, M ; Draelos, Z ; Gooderham, M ; Kempers, S ; Kircik, L ; Papp, K ; Pariser, D ; Sankeva, M ; Sinclair, R ; Zirwas, M ; Feng, A ; Burnett, P ; Higham, R ; Berk, D (National Society for Cutaneous Medicine, 2021-11-05)
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    Trichodynia and telogen effluvium in COVID-19 patients: Results of an international expert opinion survey on diagnosis and management.
    Starace, M ; Iorizzo, M ; Sechi, A ; Alessandrini, AM ; Carpanese, M ; Bruni, F ; Vara, G ; Apalla, Z ; Asz-Sigall, D ; Barruscotti, S ; Camacho, F ; Doche, I ; Estrada, BD ; Dhurat, R ; Gavazzoni, MF ; Grimalt, R ; Harries, M ; Ioannidis, D ; McMichael, A ; Melo, DF ; Oliveira, R ; Ovcharenko, Y ; Pirmez, R ; Ramot, Y ; Rudnicka, L ; Shapiro, J ; Silyuk, T ; Sinclair, R ; Tosti, A ; Vano-Galvan, S ; Piraccini, BM (Elsevier BV, 2021-12)
    BACKGROUND: The cutaneous manifestations of COVID-19 may be useful disease markers and prognostic indicators. Recently, postinfectious telogen effluvium and trichodynia have also been reported. OBJECTIVE: To evaluate the presence of trichodynia and telogen effluvium in patients with COVID-19 and describe their characteristics in relation to the other signs and symptoms of the disease. METHODS: Patients with a history of COVID-19 presenting to the clinics of a group of hair experts because of telogen effluvium and/or scalp symptoms were questioned about their hair signs and symptoms in relation to the severity of COVID-19 and associated symptoms. RESULTS: Data from 128 patients were collected. Telogen effluvium was observed in 66.3% of the patients and trichodynia in 58.4%. Trichodynia was associated with telogen effluvium in 42.4% of the cases and anosmia and ageusia in 66.1% and 44.1% of the cases, respectively. In majority (62.5%) of the patients, the hair signs and symptoms started within the first month after COVID-19 diagnosis, and in 47.8% of the patients, these started after 12 weeks or more. LIMITATIONS: The recruitment of patients in specialized hair clinics, lack of a control group, and lack of recording of patient comorbidities. CONCLUSION: The severity of postviral telogen effluvium observed in patients with a history of COVID-19 infection may be influenced by COVID-19 severity. We identified early-onset (<4 weeks) and late-onset (>12 weeks) telogen effluvium.
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    A review of actinic keratosis, skin field cancerisation and the efficacy of topical therapies
    Sinclair, R ; Baker, C ; Spelman, L ; Supranowicz, M ; MacMahon, B (WILEY, 2021-05)
    While a wide range of treatments exist for actinic keratosis and skin field cancerisation, the long-term benefits of the most common topical therapies are poorly defined. This report reviews the efficacy of the most commonly used topical therapies to treat regional or field lesions. Limited clinical and histopathological data are available on clearance rates at 12 months post-treatment for the most commonly used agents, with varied outcome measures making any comparison difficult. In general, total field clearance rates at 12 months are suboptimal for the most commonly employed agents. Given the increasing incidence of actinic keratosis and skin field cancerisation due to an ageing population, further research into the efficacy of therapies is critical to guide treatment choice.
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    Proxalutamide Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial (Publication with Expression of Concern. See vol. 8, 2022) (Retracted article. See vol. 9, 2022)
    McCoy, J ; Goren, A ; Cadegiani, FA ; Vano-Galvan, S ; Kovacevic, M ; Situm, M ; Shapiro, J ; Sinclair, R ; Tosti, A ; Stanimirovic, A ; Fonseca, D ; Dorner, E ; Onety, DC ; Zimerman, RA ; Wambier, CG (FRONTIERS MEDIA SA, 2021-07-19)
    Antiandrogens have demonstrated a protective effect for COVOD-19 patients in observational and interventional studies. The goal of this study was to determine if proxalutamide, an androgen receptor antagonist, could be an effective treatment for men with COVID-19 in an outpatient setting. A randomized, double-blinded, placebo-controlled clinical trial was conducted at two outpatient centers (Brasilia, Brazil). Patients were recruited from October 21 to December 24, 2020 (clinicaltrials.gov number, NCT04446429). Male patients with confirmed COVID-19 but not requiring hospitalization (COVID-19 8-point ordinal scale <3) were administered proxalutamide 200 mg/day or placebo for up to 7 days. The primary endpoint was hospitalization rate at 30 days post-randomization. A total of 268 men were randomized in a 1:1 ratio. 134 patients receiving proxalutamide and 134 receiving placebo were included in the intention-to-treat analysis. The 30-day hospitalization rate was 2.2% in men taking proxalutamide compared to 26% in placebo, P < 0.001. The 30-day hospitalization risk ratio was 0.09; 95% confidence interval (CI) 0.03-0.27. Patients in the proxalutamide arm more frequently reported gastrointestinal adverse events, however, no patient discontinued treatment. In placebo group, 6 patients were lost during follow-up, and 2 patients died from acute respiratory distress syndrome. Here we demonstrate the hospitalization rate in proxalutamide treated men was reduced by 91% compared to usual care.
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    Frontal fibrosing alopecia
    Kerkemeyer, KLS ; Eisman, S ; Bhoyrul, B ; Pinczewski, J ; Sinclair, RD (Elsevier, 2021)
    Frontal fibrosing alopecia (FFA) is a patterned primary cicatricial alopecia that was first described in 1994. Once rare, the incidence of FFA has increased dramatically, representing the current most common cause of cicatricial alopecia worldwide. FFA typically begins in postmenopausal women with symmetrical, progressive recession of the frontotemporal hairline together with bilateral loss of the eyebrows. FFA has a distinctive clinical phenotype, which remains a challenge. The histology is identical to lichen planopilaris (LPP), but only a small number of patients have coincidental LPP, usually of the scalp. The vast majority of patients have no evidence of lichen planus elsewhere, and the symmetry and patterned nature of the hair loss are unusual for LPP. Familial cases of FFA are reported, and gene associations have been identified in population studies; however, the pathophysiology remains controversial. Without treatment, FFA is slowly progressive, and although many treatments have been prescribed, the response is often disappointing. We review the pathogenesis, epidemiology, clinical features, histology, and treatment of FFA.
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    Androgen receptor genetic variant predicts COVID-19 disease severity: a prospective longitudinal study of hospitalized COVID-19 male patients
    Mccoy, J ; Wambier, CG ; Herrera, S ; Vano-Galvan, S ; Gioia, F ; Comeche, B ; Ron, R ; Serrano-Villar, S ; Iwasiow, RM ; Tayeb, MA ; Cadegiani, FA ; Mesinkovska, NA ; Shapiro, J ; Sinclair, R ; Goren, A (WILEY, 2021-01)
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    Anti-androgens may protect against severe COVID-19 outcomes: results from a prospective cohort study of 77 hospitalized men
    Goren, A ; Wambier, CG ; Herrera, S ; McCoy, J ; Vano-Galvan, S ; Gioia, F ; Comeche, B ; Ron, R ; Serrano-Villar, S ; Ramos, PM ; Cadegiani, FA ; Kovacevic, M ; Tosti, A ; Shapiro, J ; Sinclair, R (WILEY, 2021-01)
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    Androgenetic alopecia may be associated with weaker COVID-19 T-cell immune response: An insight into a potential COVID-19 vaccine booster
    Goren, A ; Cadegiani, FA ; Wambier, CG ; Vano-Galvan, S ; Tosti, A ; Shapiro, J ; Mesinkovska, NA ; Ramos, PM ; Sinclair, R ; Lupi, O ; Hercogova, J ; McCoy, J (CHURCHILL LIVINGSTONE, 2021-01)
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    Treatment of alopecia areata in pre-adolescent children with oral tofacitinib: A retrospective study
    Jerjen, R ; Meah, N ; Trindade de Carvalho, L ; Wall, D ; Eisman, S ; Sinclair, R (WILEY, 2021-01)
    BACKGROUND: Alopecia areata (AA) is an autoimmune hair loss condition that affects people of all ages. Early age of onset and prolonged disease duration indicate poor prognosis. Janus kinase inhibitors are being investigated in phase 3 clinical trials in adolescents and adults with AA OBJECTIVE: To evaluate the use of oral tofacitinib in pre-adolescent patients with AA. METHODS: A retrospective review of case records of all pre-adolescent patients with AA treated with oral tofacitinib in a single center between 2018 and 2019. RESULTS: Fourteen patients were identified, aged 7 to 11 years. Nine patients experienced clinically significant improvement in their SALT (Severity of Alopecia Tool) score. Three patients achieved complete remission (SALT score of 0), seven (63.6%) achieved over 50% improvement in SALT score from baseline. One patient had no change from baseline, another experienced additional hair loss. After an average of 9 months of treatment, the median SALT score improvement was 67.7%. The improvement was similar in patients with baseline SALT scores greater than 50 and those with baseline SALT scores below 10. Adverse events were mild. LIMITATIONS: The retrospective nature of the data, small sample size, lack of a control group, referral bias to a specialist hair center, and concomitant use of other medications including oral minoxidil in all patients. CONCLUSION: There is a role for tofacitinib as a systemic therapy in AA and this should be further evaluated in prospective clinical trials in pre-adolescents.
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