Document Detail


An open-label, community-based, 12-week assessment of the effectiveness and safety of monotherapy with doxycycline 40 mg (30-mg immediate-release and 10-mg delayed-release beads).
MedLine Citation:
PMID:  21229826     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Rosacea is a common inflammatory disorder of the skin of middle-aged and older adults. A unique 40-mg formulation of doxycycline (30-mg immediate-release and 10-mg delayed-release beads) developed for its anti-inflammatory properties is the only US Food and Drug Administration-approved oral medication for the disorder. This report describes the results of the Oracea for Rosacea: A Community-Based Assessment (ORCA) trial, a phase 4 trial of the 40-mg formulation as monotherapy in adults with mild to severe papulopustular rosacea. A total of 1197 participants were enrolled in the monotherapy arm of the 12-week open-label study at 271 community-based investigational sites. The primary outcome measure was a change in the 5-point investigator global assessment (IGA) score from baseline to end point (week 12). Secondary outcome measures included change in the 5-point clinician erythema assessment (CEA) score from baseline to end point, IGA success, and adverse events (AEs). The monotherapy per-protocol (PP) population was selected a priori as the primary analysis population and safety assessments were performed on all participants who received at least 1 dose of the study drug. In the PP population of 826 monotherapy participants who completed the trial, approximately 75% of participants with mild to severe rosacea at baseline were clear or near clear by week 12, according to IGA scores. Furthermore, approximately 75% of participants had CEA scores reflecting none or mild erythema after 12 weeks. In the safety population of 1196 participants, treatment-related AEs were reported in 6.7% of participants that were mainly mild or moderate in severity. Adverse events that occurred in more than 1% of the safety population included diarrhea (1.2%), nausea (1.3%), and headache (1.0%). The incidence of fungal and yeast infections was 0.4%. The results of the ORCA trial support the effectiveness and safety of the 40-mg formulation of doxycycline in patients with papulopustular rosacea.
Authors:
Guy F Webster
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Publication Detail:
Type:  Clinical Trial, Phase IV; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Cutis     Volume:  86     ISSN:  0011-4162     ISO Abbreviation:  Cutis     Publication Date:  2010 Nov 
Date Detail:
Created Date:  2011-01-14     Completed Date:  2011-02-24     Revised Date:  2013-09-12    
Medline Journal Info:
Nlm Unique ID:  0006440     Medline TA:  Cutis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  7-15     Citation Subset:  IM    
Affiliation:
Jefferson Medical College, Philadelphia, Pennsylvania, USA.
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Anti-Bacterial Agents / administration & dosage,  adverse effects,  therapeutic use*
Delayed-Action Preparations
Doxycycline / administration & dosage,  adverse effects,  therapeutic use*
Female
Humans
Male
Middle Aged
Rosacea / drug therapy*
Severity of Illness Index
Treatment Outcome
Chemical
Reg. No./Substance:
0/Anti-Bacterial Agents; 0/Delayed-Action Preparations; 564-25-0/Doxycycline

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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