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Версія від 10:46, 19 червня 2017, створена Drawer9parade (обговореннявнесок) (Створена сторінка: 6 Methods This parallel group, randomised, controlled trial with assessor blinding was undertaken at a hospital-based research facility and four community-based...)

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6 Methods This parallel group, randomised, controlled trial with assessor blinding was undertaken at a hospital-based research facility and four community-based research and/or primary care sites in New Zealand. Ethics approval was obtained from the Central Health and Disability Ethics Committee (13/CEN/118). Adults aged 16 or over with a doctor's diagnosis of rosacea on the face, and a baseline blinded Investigator Global Assessment of Rosacea Severity Score (IGA-RSS) of facial rosacea of ��2 were recruited. The IGA-RSS is a 7-point scale (from 0: ��clear��, to 6: ��severe��) that provides an integrated assessment of rosacea severity based on the principal facial signs of papules/pustules, inflammatory lesions, erythema and telangiectasia5 (see online supplementary table S1). Participants were identified at the time of first presentation or, with their primary care practitioner's consent, from pre-existing databases, or by public advertisement. Exclusion criteria included current requirement for systemic corticosteroids, or systemic corticosteroid treatment in the 4?weeks prior to visit 1, current requirement for oral or topical antibiotic therapy for rosacea, current requirement for topical corticosteroid treatment for rosacea, known or suspected allergy to honey, or Cetomacrogol control cream, or any other condition which, at the investigators discretion, it was believed may present a safety risk or impact the feasibility of the study or the study results. Participants attended for 3 visits (see online supplementary table S2). Visit 1 (week 0) consisted of consent, baseline assessments (the IGA-RSS), a participant-rated rosacea severity visual analogue score (VAS-S) on a 100?mm scale (0?mm being ��mildest possible�� symptoms and 100?mm being ��worst possible�� symptoms), and a participant-rated dermatology quality of life index (DLQI),20 followed by randomisation to Honevo or Cetomacrogol cream (control). At visit 2 (week 2) and visit 3 (week 8), as well as the IGA-RSS and the DLQI, participants completed a subjective rosacea ��change in severity�� visual analogue scale (VAS-CS) on a 100?mm scale (0?mm being ��much worse�� and 100?mm being ��much improved��). Participants�� diaries were used throughout the study to capture each participant's weekly subjective VAS-S, their use of Telomerase randomised treatment throughout the 8-week study period, and any general comments including adverse events throughout the study. Randomisation and blinding Treatment allocation was randomised using a computer generated sequence concealed to investigators by enclosing the proposed treatment arm in an opaque envelope that was opened only by primary investigators after informed consent was obtained from each participant. Participants were randomised in a 1:1 ratio to the topical application of Honevo or control cream.