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Safety and efficacy study data Cestrum diurnum extract Ointment containing Natural Calcitriol in the treatment of Mild to Moderate Plaque Psoriasis DR.G. Raghurama Rao, M.D Professor & HOD of DVL, GSL Medical College, Rajahmundry. Consultant Dermatologist, Surya Skin Care and Research Centre, Visakhapatnam. Background • First time in the world, natural calcitriol from plant source (Solanacea) is being commercially produced by the pioneering work of Genova Biotech, Hyderabad. • Calcitriol is a D3 analogue known to be the most effective non-steroidal alternative in the treatment of mild to moderate plaque psoriasis. • This is also the preferred drug of choice in treating sensitive areas such as scalp, post auricular area and flexures. 2 Study Design • Single centre, non randomized, open label Phase III Study • Objective: To study the efficacy, safety, and patient compliance of topical Cestrum diurnum extract 1%w/w) • ointment containing natural calcitriol, 0.0003% (3mcg/gm) in the treatment of mild to moderate plaque psoriasis • Study Period: 01-Feb-2010 to 30-Jun-2010 • Total no. of subjects inducted into study - 53 • A total of 46 patients with a mean age of 41.6 yrs completed study specific procedures. a) 28 patients with psoriasis involving arms/trunk/legs b) 18 patients with scalp psoriasis • Dropouts - 7 3 Inclusion Criteria • Male and female patients aged 18 years or above • Psoriasis vulgaris involving arms / trunk / legs / scalp • Patients were enrolled after informed consent • Women of childbearing ability to undergo urine pregnancy testing • Subjects who completed medical screening • Subjects who could be available for all study related visits 4 Exclusion Criteria • Patients with acute guttate, generalized pustular or erythrodermic exfoliative psoriasis, atopic dermatitis, seborrhoeic dermatitis or other inflammatory skin diseases • Systemic antipsoriatic treatment or phototherapy within the last 6 weeks • Patients who used any topical antipsoriatic treatment on the body within the previous 2 weeks, except emollients. • Usage of corticosteroids for any reason within the last 6 weeks of the start of the Study • Patients with planned changes in the concomitant medications (e.g. beta blockers, lithium etc.) that affect their psoriasis during the study period 5 Exclusion Criteria – Cont. • Women who are breast feeding, pregnant or wish to become pregnant during study • Subjects with eye infections • Who had received treatment with an investigational drug within last 3 months and who are currently participating in any of the clinical trial • Subjects with uncontrolled metabolic diseases such as diabetes/hypertension, hyper or hypothyroidism • Subjects with abnormal liver / renal function tests and known hypercalcinosis 6 Method • At baseline, informed consent was obtained after checking the inclusion and exclusion criteria and relevant medical history • All prior medications were stopped 2 weeks before the start of the study • Only application of an emollient (coconut oil) was permitted • Total lesion severity scores (TLSS) and global assessment scoring system were administered throughout the study • Patients were enquired about adverse events and compliance with the study medication on all follow ups • The patients were asked to apply the ointment twice daily • No concomitant drugs were allowed during the study • Photographic evaluation was also done • Statistical methods were employed to study the significance level from baseline to follow up 7 TLSS and Global Assessment • Changes in the mean TLSS and global assessment were compared from baseline to follow up • There was extremely significant decrease in the scores 1. Erythema (p=<0.0001) 2. Infiltration (p=<0.0001) 3. Scaling (p=<0.0001) • One patient reported mild irritation • No other adverse effects were observed during the follow up period of 4 months • No relapses were observed, up to 4 months after study 8 Total Lesion Severity Score 9 Results • 54% cases, total clearance was observed after 8 weeks • 22% cases total clearance after 12 weeks • 9% cases total clearance after 16 weeks • 2% cases total clearance after 20 weeks • 13% cases poor or no response 10 Baseline Global Assessment Score 11 Change in Global Assessment – After 12 weeks 12 Change from Baseline – After 12 weeks 13 Change in Global Assessment – After 20 weeks 14 Change from Baseline – After 20 weeks 15 Clinical Photographs BEFORE AFTER 16 Clinical Photographs BEFORE AFTER 17 Clinical Photographs Before After 18 Clinical Photographs Before After 19 Clinical Photographs Before After 20 Clinical Photographs Before After 21 Clinical Photographs Before After 22 Clinical Photographs Before After 23 Clinical Photographs Before After 24 Comment Cestrum diurnum extract 1% w/w ointment containing(Natural Calcitriol) is a safe and effective treatment and alternative to topical steroids in the treatment of mild to moderate plaque psoriasis of body and scalp 25 Thank You!