Document Detail

Double-blind comparison of azelaic acid 20% cream and its vehicle in treatment of papulo-pustular rosacea.
MedLine Citation:
PMID:  10598760     Owner:  NLM     Status:  MEDLINE    
Previous investigations have indicated that topical azelaic acid has beneficial effects in rosacea. This 3-month randomized, double-blind, multicentre study compared the efficacy and safety of azelaic acid 20% cream with its vehicle, in the treatment of papulo-pustular rosacea. A total of 116 patients were enrolled in the study and medication was applied twice daily. Azelaic acid cream produced significantly greater mean reductions in total inflammatory lesions than did vehicle (azelaic acid: 73.4%; vehicle: 50.6%; (p = 0.011), and erythema severity score (azelaic acid: 47.9%; vehicle: 37.9%; (p = 0.031). Azelaic acid cream treatment also resulted in significantly more favourable overall improvements than vehicle in both physician (p = 0.020) and patient ratings (p = 0.042). Neither azelaic acid cream nor vehicle produced any clinically relevant improvement in telangiectasia. Local adverse events were transient and mainly mild or moderate, and rates were similar for azelaic acid cream (39.5%) and vehicle (38.5%). Burning was the symptom most frequently reported. More than 90% of patients rated the overall local tolerability of their treatment as good or acceptable. In conclusion, azelaic acid 20% cream is effective and well tolerated in the treatment of papulo-pustular rosacea.
R Bjerke; O Fyrand; K Graupe
Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Acta dermato-venereologica     Volume:  79     ISSN:  0001-5555     ISO Abbreviation:  Acta Derm. Venereol.     Publication Date:  1999 Nov 
Date Detail:
Created Date:  2000-01-21     Completed Date:  2000-01-21     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0370310     Medline TA:  Acta Derm Venereol     Country:  NORWAY    
Other Details:
Languages:  eng     Pagination:  456-9     Citation Subset:  IM    
Department of Dermatology, Ullevål Hospital, Oslo, Norway.
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MeSH Terms
Administration, Cutaneous
Dermatologic Agents / administration & dosage*
Dicarboxylic Acids / administration & dosage*
Double-Blind Method
Follow-Up Studies
Middle Aged
Reference Values
Rosacea / drug therapy*,  pathology
Severity of Illness Index
Statistics, Nonparametric
Treatment Outcome
Vehicles / administration & dosage
Reg. No./Substance:
0/Dermatologic Agents; 0/Dicarboxylic Acids; 0/Vehicles; 123-99-9/azelaic acid

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