PMID- 21229826
OWN - NLM
STAT- MEDLINE
DCOM- 20110224
LR  - 20131121
IS  - 0011-4162 (Print)
IS  - 0011-4162 (Linking)
VI  - 86
IP  - 5 Suppl
DP  - 2010 Nov
TI  - 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).
PG  - 7-15
AB  - 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.
FAU - Webster, Guy F
AU  - Webster GF
AD  - Jefferson Medical College, Philadelphia, Pennsylvania, USA.
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Cutis
JT  - Cutis
JID - 0006440
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Delayed-Action Preparations)
RN  - N12000U13O (Doxycycline)
SB  - IM
MH  - Administration, Oral
MH  - Anti-Bacterial Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Delayed-Action Preparations
MH  - Doxycycline/administration & dosage/adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Rosacea/*drug therapy
MH  - Severity of Illness Index
MH  - Treatment Outcome
EDAT- 2011/01/15 06:00
MHDA- 2011/02/25 06:00
CRDT- 2011/01/15 06:00
PHST- 2011/01/15 06:00 [entrez]
PHST- 2011/01/15 06:00 [pubmed]
PHST- 2011/02/25 06:00 [medline]
PST - ppublish
SO  - Cutis. 2010 Nov;86(5 Suppl):7-15.