scholarly journals The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis

2017 ◽  
Vol 176 (4) ◽  
pp. 928-938 ◽  
Author(s):  
C.E.M. Griffiths ◽  
D. Thaçi ◽  
S. Gerdes ◽  
P. Arenberger ◽  
G. Pulka ◽  
...  
Keyword(s):  
Blind Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Plaque Type ◽  
Originator Product

Management of Psoriasis Vulgaris with Methotrexate 0.25% in a Hydrophilic Gel: A Placebo-Controlled, Double-Blind Study

2001 ◽  
Vol 5 (4) ◽  
pp. 299-302 ◽  
Author(s):  
Tanweer A. Syed ◽  
Suhail M. Hadi ◽  
Zulfiqar A. Qureshi ◽  
Christine G. Nordstrom ◽  
Shahida M. Ali
Keyword(s):  
Psoriasis Vulgaris ◽  
Topical Therapy ◽  
Severity Index ◽  
Blind Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Plaque Type ◽  
Normal Limits ◽  
Pasi Score ◽  
Hydrophilic Gel

Background: Methotrexate has been used as one of the first and systemic therapies for psoriasis. In general, 70% of patients with psoriasis prefer topical therapy as the treatment of choice. Objective: The purpose of this placebo-controlled double-blind study was to evaluate the clinical efficacy and tolerability of methotrexate 0.25% incorporated in a hydrophilic gel (hydroxyethylcellulose 1%) to treat patients afflicted with psoriasis vulgaris. Methods: Sixty patients (37M/23F) ranging between 18 and 70 years of age, with slight to moderate chronic plaque-type psoriasis and PASI (Psoriasis Area and Severity Index) scores between 5.3 and 17.5 joined the study. The mean duration of the disease at entry was 9.6 years (range 1–24 years). The diagnosis of psoriasis was established by clinical and histopathologic methods. Patients were sequentially randomized into two parallel groups. Each patient was allocated a precoded 100-g tube (active or placebo) with instructions on how to self-administer the trial medication topically (without occlusion) to their lesions two times daily for 5 consecutive days per week. The study lasted for 12 weeks with 4 weeks of active treatment. Patients were examined on a weekly basis and those showing total clearing or remission of lesions were considered effectively treated. Results: By the end of the treatment, breaking the code disclosed that methotrexate 0.25% gel had significantly treated more patients than placebo (83.3% vs. 6.7%; p < 0.0001), reduced the PASI score to a mean of 2.2, and cleared more plaques (82.2% vs. 4.3%; p < 0.0001). Laboratory evaluations, including CBC with differential and platelet count, renal function, liver chemistry [SGOT (aspartate transaminase) and SGPT (alanine transaminase)], and serum creatinine, were within the normal limits. The treatment was well-tolerated by all the patients, with no adverse drug-related symptoms and no dropouts. The study was followed up for 12 months from the first day of the treatment; two cured patients had relapsed after 8 months. Conclusion: The findings of this study demonstrate that methotrexate 0.25% in a hydrophilic gel is well tolerated and significantly more effective than placebo as a patient-applied topical medication to treat psoriasis vulgaris.

Double-Blind Study of Antihistaminic Drugs

1973 ◽  
Vol 35 (5) ◽  
pp. 627-633
Author(s):  
Masayuki SHIMIZU ◽  
Yoshiko HIDAKA ◽  
Ryuhji TAKEUCHI
Keyword(s):  
Blind Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Antihistaminic Drugs

OnabotulinumtoxinA for Treatment of Moderate-to-Severe Horizontal Lines and Glabellar Lines from the Subject's Perspective: Patient-Reported Satisfaction and Impact Outcomes from a Phase 3 Double-Blind Study

2017 ◽  
Vol 1 ◽  
pp. s82
Author(s):  
Steven Dayan ◽  
Patricia Ogilvie ◽  
Alexander Z Rivkin ◽  
Steven G Yoelin ◽  
Julie K Garcia ◽  
...  
Keyword(s):  
Blind Study ◽  
Double Blind Study ◽  
Phase 3 ◽  
Double Blind ◽  
Patient Reported

Abstract Not Available Disclosures: Study supported by Allergan.

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