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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    Female pattern hair loss: a pilot study investigating combination therapy with low-dose oral minoxidil and spironolactone
    Sinclair, RD (WILEY, 2018-01)
    BACKGROUND: Minoxidil and spironolactone are oral antihypertensives known to stimulate hair growth. OBJECTIVE: To report on a case series of women with pattern hair loss (PHL) treated with once daily minoxidil 0.25 mg and spironolactone 25 mg. METHODS: Women newly diagnosed with a Sinclair stage 2-5 PHL were scored for hair shedding and hair density before and after 12 months of treatment with oral minoxidil 0.25 mg and spironolactone 25 mg. RESULTS: A total of 100 women were included in this observational pilot study. Mean age was 48.44 years (range 18-80). Mean hair loss severity at baseline was Sinclair 2.79 (range 2-5). Mean hair shedding score at baseline was 4.82. Mean duration of diagnosis was 6.5 years (range 0.5-30). Mean reduction in hair loss severity score was 0.85 at 6 months and 1.3 at 12 months. Mean reduction in hair shedding score was 2.3 at 6 months and 2.6 at 12 months. Mean change in blood pressure was -4.52 mmHg systolic and -6.48 mmHg diastolic. Side effects were seen in eight women but were generally mild. No patients developed hyperkalemia or any other blood test abnormality. Six of these women continued treatment, and two women who developed urticaria discontinued treatment. LIMITATIONS: Prospective, uncontrolled, open-label observational study. DISCUSSION: Once daily capsules containing minoxidil 0.25 mg and spironolactone 25 mg appear to be safe and effective in the treatment of FPHL. Placebo-controlled studies to investigate this further are warranted.
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    Styling without shedding: Novel topical formula reduces hair shedding by contracting the arrector pili muscle
    McCoy, J ; Goren, A ; Kovacevic, M ; Situm, M ; Stanimirovic, A ; Shapiro, J ; Sinclair, R (WILEY, 2018-01)
    Approximately 40% of women experience excessive hair shedding during styling (e.g., hair brushing). Previously, we demonstrated that topically applied phenylephrine, a potent α1 adrenergic receptor agonist, can be used to contract the arrector pili muscle of the follicular unit; thus, increasing the force required to pluck hair and reducing shedding during brushing. While demonstrating efficacy, phenylephrine has several drawbacks when applied to the scalp, including the possibility cardiovascular events. We hypothesized that a high concentration of a weak α1 agonist would allow for: (a) rapid penetration through the stratum corneum eliciting a quick response; (b) a low probability of cardiac adverse events owing to the low receptor binding affinity; and (c) an efficacy of the weak α1 agonist similar to that of phenylephrine at the local site of application. Accordingly, we developed a novel topical solution, AB-102, containing a high concentration of a weak α1 agonist. Several studies were conducted to test the safety and efficacy of AB-102. In a dose escalating safety study, utilizing a wearable holter monitor, we observed no cardiac or hemodynamic adverse events. In addition, in a controlled efficacy study, AB-102 reduced the number of hairs shed during brushing by up to 77% (average of 38%).
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    Development and validation of the International Hidradenitis Suppurativa Severity Score System (IHS4), a novel dynamic scoring system to assess HS severity
    Zouboulis, CC ; Tzellos, T ; Kyrgidis, A ; Jemec, GBE ; Bechara, FG ; Giamarellos-Bourboulis, EJ ; Ingram, JR ; Kanni, T ; Karagiannidis, I ; Martorell, A ; Matusiak, L ; Pinter, A ; Prens, EP ; Presser, D ; Schneider-Burrus, S ; von Stebut, E ; Szepietowski, JC ; van der Zee, HH ; Wilden, SM ; Sabat, R (WILEY, 2017-11)
    BACKGROUND: A validated tool for the dynamic severity assessment of hidradenitis suppurativa/acne inversa (HS) is lacking. OBJECTIVES: To develop and validate a novel dynamic scoring system to assess the severity of HS. METHODS: A Delphi voting procedure was conducted among the members of the European Hidradenitis Suppurativa Foundation (EHSF) to achieve consensus towards an initial HS Severity Score System (HS4). Strengths and weaknesses of HS4 were examined by a multicentre prospective study. Multivariate logistic regression, discriminant analysis and receiver operating characteristic curves, as well as examination for correlation (Spearman's rho) and agreement (Cohen's kappa) with existing scores, were engaged to recognize the variables for a new International HS4 (IHS4) that was established by a second Delphi round. RESULTS: Consensus HS4 was based on number of skin lesions, number of skin areas involved and Dermatology Life Quality Index (DLQI), and was evaluated by a sample of 236 patients from 11 centres. Subsequently, a multivariate regression model calculated adjusted odds ratios for several clinical signs. Nodules, abscesses and draining tunnels resulted as the scoring variables. Three candidate scores were presented to the second Delphi round. The resulting IHS4 score is arrived at by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild, 4-10 signifies moderate and 11 or higher signifies severe disease. Cohen's kappa was fair (κ = 0·32) compared with Hurley classification, and moderate (κ = 0·49) compared with Expert Opinion. Correlation was good (ρ > 0·6) with Hurley classification, Expert Opinion, Physician's Global Assessment and Modified Sartorius score, and moderate for DLQI (ρ = 0·36). CONCLUSIONS: The novel IHS4 is a validated tool to dynamically assess HS severity and can be used both in real-life and the clinical trials setting.
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    Measuring the impact of alopecia areata
    Sinclair, R (WILEY-BLACKWELL, 2016-09)
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    Hair transplantation in mice: Challenges and solutions
    Asgari, AZ ; Rufaut, NW ; Morrison, WA ; Dilley, RJ ; Knudsen, R ; Jones, LN ; Sinclair, RD (WILEY-BLACKWELL, 2016-07)
    Hair follicle cells contribute to wound healing, skin circulation, and skin diseases including skin cancer, and hair transplantation is a useful technique to study the participation of hair follicle cells in skin homeostasis and wound healing. Although hair follicle transplantation is a well-established human hair-restoration procedure, follicular transplantation techniques in animals have a number of shortcomings and have not been well described or optimized. To facilitate the study of follicular stem and progenitor cells and their interaction with surrounding skin, we have established a new murine transplantation model, similar to follicular unit transplantation in humans. Vibrissae from GFP transgenic mice were harvested, flip-side microdissected, and implanted individually into needle hole incisions in the back skin of immune-deficient nude mice. Grafts were evaluated histologically and the growth of transplanted vibrissae was observed. Transplanted follicles cycled spontaneously and newly formed hair shafts emerged from the skin after 2 weeks. Ninety percent of grafted vibrissae produced a hair shaft at 6 weeks. After pluck-induced follicle cycling, growth rates were equivalent to ungrafted vibrissae. Transplanted vibrissae with GFP-positive cells were easily identified in histological sections. We established a follicular vibrissa transplantation method that recapitulates human follicular unit transplantation. This method has several advantages over current protocols for animal hair transplantation. The method requires no suturing and minimizes the damage to donor follicles and recipient skin. Vibrissae are easier to microdissect and transplant than pelage follicles and, once transplanted, are readily distinguished from host pelage hair. This facilitates measurement of hair growth. Flip-side hair follicle microdissection precisely separates donor follicular tissue from interfollicular tissue and donor cells remain confined to hair follicles. This makes it possible to differentiate migration of hair follicle cells from interfollicular epidermis in lineage tracing wound experiments using genetically labeled donor follicles.
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    Secukinumab improves patient-reported psoriasis symptoms of itching, pain, and scaling: results of two phase 3, randomized, placebo-controlled clinical trials
    Strober, B ; Sigurgeirsson, B ; Popp, G ; Sinclair, R ; Krell, J ; Stonkus, S ; Septe, M ; Elewski, BE ; Gottlieb, AB ; Zhao, Y ; Tran, MH ; Karpov, A ; McLeod, LD ; Mordin, M ; Papavassilis, C ; Nyirady, J ; Lebwohl, M (WILEY-BLACKWELL, 2016-04)
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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.