Zyclara Clinical Studies

Targeted Transient Ribosomal Inhibition (TTRI)
• Evaluated in 4 Phase I and 7 Phase II Clinical Studies for Cancer (late 70’s) Safety: • Reversible - intracellularly inactivated in 12 hours Zyclara Top. imiquimod Unknown: Immune Activator Graceway 2 mo: 26% - 46% complete clearance (2 studies) ... Doc Retrieval

Aldara - Aldara For Skin Cancer Treatment
The approval of imiquimod was based on two clinical trials involving 364 patients with primary superficial basal cell carcinomas. studies have shown that the use of imiquimod is more cost-effective than surgical interventions among patients with superficial BCC. ... Read Article

Zyclara is a hybrid of Aldara, which has been authorised in the EU since 18 September 1998. studies and new clinical studies have been carried out. The benefits with Zyclara are that it has lower concentration of active substance than Aldara allowing ... Fetch Content

Basal-cell Carcinoma - Wikipedia, The Free Encyclopedia
There are no good studies, however, comparing cryosurgery with other modalities, particularly with Mohs surgery, excision, or electrodesiccation and curettage so that no conclusion can be made whether cryosurgery is as efficacious as other methods. ... Read Article

Zyclara 2.5% PI 3M 03-06-12 V2
14 CLINICAL STUDIES 3.75%14.1 Actinic Keratosis 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION 17.1 Instructions for Administration Clinical studies of ZYCLARA Cream for EGW did not include sufficientnumbers ... Read Content

Reference ID: 2974605 - U S Food And Drug Administration Home ...
Clinical studies of ZYCLARA Cream for EGW did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Of the 400 subjects treated with ZYCLARA Cream, 3.75% in the EGW clinical studies, 5 ... Access Document

VESANOID (tretinoin)
Clinical Studies. VESANOID has been investigated in 114 previously treated APL patients and in 67 previously untreated (“de novo”) patients in one open-label, uncontrolled single investigator clinical study (Memorial Sloan-Kettering ... Retrieve Document

Imiquimod - Wikipedia, The Free Encyclopedia
Clinical data; Trade names: Aldara: AHFS/Drugs.com: MedlinePlus: Licence data: Graceway Pharmaceuticals and iNova Pharmaceuticals under the trade names Aldara and Zyclara, and by Mochida as Beselna. It is also referred to as R-837. ... Read Article

C:Documents And SettingsDavNStatRev N 201153 000[1]
The clinical study program for Zyclara for genital warts is presented in Table 2. NDA 201153 / 000 [Zyclara (imiquimod) 3.75%] 4 _____ Table 2 – Clinical Study Program for concentration of imiquimod evaluated in the clinical studies (2.5%) was superior to ... Retrieve Doc

To Plan policies, clinical coding criteria, generically available. Please note: Zyclara However, studies have shown a recurrence rate of up to 60% in patients initially cleared. Imiquimod is an alternative treatment ... Access Full Source

Sjögren's Syndrome - Wikipedia, The Free Encyclopedia
The UK Primary Sjögren's Syndrome Registry supports clinical trials and genetic studies of Sjögren's syndrome and is open to patients wishing to participate in research studies and researchers studying the disease. ... Read Article

ANNEX 1 SUMMARY OF PRODUCT CHARACTERISTICS
- exposure to Zyclara or vehicle in above mentioned studies (frequencies very common to uncommon and at greater frequency after vehicle). - experience with imiquimod 5% cream . 6 Frequencies are defined as: vehicle-controlled clinical studies. ... Read Here

1-888-566-0008, 1-800-900-1451, Www.bmchp
Imiquimod, Zyclara ® Document Number: 9 conclusions based upon the regulatory status of the technology and a review of clinical studies published in peer-reviewed medical literature. Even though this policy may indicate that a ... Fetch This Document

Methotrexate May Impact Fertility In JIA Patients
Clinical studies of ZYCLARA Cream for EGW did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Of the 400 subjects treated with ZYCLARA Cream in the EGW clinical studies, 5 subjects (1%) were 65 years or older. ... Access Full Source

TATISTICAL EVIEW AND VALUATION - U S Food And Drug ...
The clinical study program for Zyclara for genital warts is presented in Table 2. _____ NDA 201153 / 000 [Zyclara (imiquimod) 3.75%] 4 : Table 2 concentration of imiquimod evaluated in the clinical studies (2.5%) was superior to ... Retrieve Full Source

Aldara/Zyclara (imiquimod) Prior Authorization Coverage Criteria
Aldara/Zyclara (imiquimod) Prior Authorization Coverage Criteria POLICY #: 4087 selection of patients for treatment according to product labeling and/or clinical studies and/or guidelines. The PA program defines appropriate use as ... View Full Source

201153 Imiquimod Clinical PREA - U S Food And Drug ...
Zyclara (imiquimod) cream 3.75% CLINICAL REVIEW Application Type NDA 505 (b)(1) Application Number(s) 201153 Priority or Standard Standard . Submit Date(s) February 8, 2010 7.1.1 Studies/Clinical Trials Used to Evaluate Safety ... Visit Document

Assessment Report
The data to support this application come from 4 clinical studies with 2 investigational formulations (Imiquimod 2.5% and 3.75% creams), 2 pairs of identically designed studies, with each pair having a clinical trials with Zyclara. ... Retrieve Full Source

FOR IMMEDIATE RELEASE FDA Approves Zyclara (imiquimod) Cream ...
Zyclara Cream’s clinical studies demonstrated that using its once-daily treatment regimen, for up to eight weeks, safely and effectively clears genital warts. In addition, data showed that of those patients who achieved ... Get Doc

Zyclara (Imiquimod) Cream, 3.75% Gupta, Cooper, and Abramovits PRILSoE F DERMAToPAThoLoGy CINICALL STUDIES Clinical efficacy was studied for both a 2.5% and a 3.75% formu-lation of imiquimod (Zyclara), compared with placebo (identical ... Retrieve Content

August 2011 2011–2012 Influenza Season Vaccine Drug ...
Studies. Currently, the FDA states the benefits of oral bisphosphonates in reducing Zyclara® The product labeling for Zyclara® now includes a statement warning health July 2011 Clinical Alert Author: ... Document Retrieval

New Drug Review Fall 2011 - Arkansas Pharmacists Association ...
Drug Interactions: No clinical drug-drug interaction studies have been conducted. There is minimal potential for interactions between ceftaroline and CYP450 substrates, Zyclara imiquimod Graceway New lower strength (3.75%) for actinic keratoses ... Fetch Content

Zyclara PI Printer-friendly 05-10-12
Clinical studies of ZYCLARA Cream for EGW did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Of the 400 subjects treated with ZYCLARA Cream, 3.75% in the EGW clinical studies, 5 subjects (1%) were ... View Doc

Drug Information Update May 2011
Zyclara Cream’s clinical studies demonstrated that using its once-daily treatment regimen, for up to eight weeks, safely and effectively clears genital warts. In addition, data showed that of those patients who achieved complete clearance, only ... Access Content