PMID- 19588640
OWN - NLM
STAT- MEDLINE
DCOM- 20090728
LR  - 20141120
IS  - 1545-9616 (Print)
IS  - 1545-9616 (Linking)
VI  - 8
IP  - 7
DP  - 2009 Jul
TI  - A multicenter study of topical azelaic acid 15% gel in combination with oral 
      doxycycline as initial therapy and azelaic acid 15% gel as maintenance 
      monotherapy.
PG  - 639-48
AB  - This two-phase, multicenter study was undertaken to examine the safety and 
      efficacy of combination therapy with oral doxycycline and topical azelaic acid 
      (AzA) 15% gel in moderate-to-severe papulopustular rosacea and to determine the 
      effect of subsequent maintenance monotherapy with AzA 15% gel alone. In the 
      initial open-label, non-randomized phase of the study, subjects (n=172) received 
      topical AzA 15% gel and oral doxycycline (100 mg), both twice daily, for < or = 
      12 weeks. In the second, double-blind study phase, subjects who had initially 
      undergone at least four weeks of combination treatment in phase 1 and who 
      achieved > or = 75% inflammatory lesion count reduction (n=136) were randomized 
      to receive either AzA 15% gel or its vehicle twice daily for an additional 24 
      weeks. Assessments of efficacy were obtained at four-week intervals throughout 
      both phases of the study and included change in inflammatory lesion count, 
      investigator global assessment (IGA) of rosacea severity, and separate 
      assessments of erythema and telangiectasia severity. At the last visit for each 
      phase of the study, the investigator and participant each rated overall 
      improvement, with the participant rating cosmetic acceptability and the 
      investigator rating treatment as "success" or "failure" based on IGA score. 
      During the second phase of the trial, the rate of relapse -- defined as either a 
      50% deterioration in the lesion count improvement from phase 1, an increase in 
      erythema intolerable to the subject or maintenance therapy failure as judged by 
      the investigator and/or the subject -- was obtained. Safety assessments were 
      conducted for both phases of the study and included analysis of adverse events 
      (AEs) and a rating of cutaneous tolerability by the subject. By week 12 of the 
      open-label phase of the study, 81.4% of subjects had reached a 75% or greater 
      reduction in inflammatory lesion count, and 64% of patients achieved treatment 
      success. During the second study phase (maintenance phase), AzA 15% gel 
      consistently provided a better maintenance response than vehicle, with 
      maintenance of remission in 75% of patients over the six-month duration of the 
      maintenance phase. Additionally AzA 15% gel showed a statistically significantly 
      lower deterioration in absolute inflammatory lesion counts than did vehicle after 
      8, 16, 20 and 24 weeks of maintenance therapy. No serious treatment-related AEs 
      were encountered in the study, and 98.5% of subjects were satisfied with the 
      local tolerability of both AzA gel and vehicle.
FAU - Thiboutot, Diane M
AU  - Thiboutot DM
AD  - Pennsylvania State University College of Medicine, Hershey, PA, USA.
FAU - Fleischer, Alan B
AU  - Fleischer AB
FAU - Del Rosso, James Q
AU  - Del Rosso JQ
FAU - Rich, Phoebe
AU  - Rich P
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Drugs Dermatol
JT  - Journal of drugs in dermatology : JDD
JID - 101160020
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Dermatologic Agents)
RN  - 0 (Dicarboxylic Acids)
RN  - 0 (Gels)
RN  - F2VW3D43YT (azelaic acid)
RN  - N12000U13O (Doxycycline)
SB  - IM
MH  - Administration, Cutaneous
MH  - Administration, Oral
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anti-Bacterial Agents/adverse effects/therapeutic use
MH  - Dermatologic Agents/adverse effects/*therapeutic use
MH  - Dicarboxylic Acids/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Doxycycline/adverse effects/*therapeutic use
MH  - Drug Therapy, Combination
MH  - Female
MH  - Gels
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Rosacea/*drug therapy
MH  - Severity of Illness Index
MH  - Telangiectasis/drug therapy/etiology
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2009/07/11 09:00
MHDA- 2009/07/29 09:00
CRDT- 2009/07/11 09:00
PHST- 2009/07/11 09:00 [entrez]
PHST- 2009/07/11 09:00 [pubmed]
PHST- 2009/07/29 09:00 [medline]
PST - ppublish
SO  - J Drugs Dermatol. 2009 Jul;8(7):639-48.