Cumulative irritation potential of metronidazole gel compared to azelaic acid gel after repeated applications to healthy skin

J Drugs Dermatol. 2005 Nov-Dec;4(6):727-31.

Abstract

Background: Metronidazole 0.75% gel and azelaic acid 15% gel are commonly used to treat rosacea. Irritation is a common side effect.

Objective: To assess the cumulative irritation potential of metronidazole 0.75% gel and azelaic acid 15% gel.

Methods: Metronidazole 0.75% gel, azelaic acid 15% gel, and a white petrolatum negative control were applied under occlusive conditions to the upper back of a total of 33 healthy subjects. There were twelve 24-hour applications (4 times a week) and three 72-hour applications on weekends during a 3-week period. Skin reactions (erythema score +/- other local reaction) were assessed within 15 to 30 minutes of removal of the products.

Results: The mean cumulative irritancy index of metronidazole 0.75% gel was significantly lower than that of azelaic acid 15% gel and not significantly higher than the negative control product. There was increasing cumulative irritancy with azelaic acid; no cumulative irritancy was seen for either metronidazole or white petrolatum.

Conclusion: Metronidazole 0.75% gel is less irritating in sustained use than azelaic acid 15% gel.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Cutaneous
  • Adult
  • Aged
  • Dermatologic Agents / administration & dosage
  • Dermatologic Agents / adverse effects*
  • Dicarboxylic Acids / administration & dosage
  • Dicarboxylic Acids / adverse effects*
  • Drug Administration Schedule
  • Erythema / chemically induced*
  • Female
  • Gels
  • Humans
  • Irritants / adverse effects
  • Male
  • Metronidazole / administration & dosage
  • Metronidazole / adverse effects*
  • Middle Aged
  • Petrolatum / administration & dosage
  • Skin / drug effects*
  • Skin Irritancy Tests / methods
  • Time Factors

Substances

  • Dermatologic Agents
  • Dicarboxylic Acids
  • Gels
  • Irritants
  • Metronidazole
  • Petrolatum
  • azelaic acid