Cumulative irritation potential among metronidazole gel 1%, metronidazole gel 0.75%, and azelaic acid gel 15%.
Topical therapy for rosacea aims to reduce inflammatory lesions and decrease erythema but can carry side effects such as stinging, pruritus, and burning. Metronidazole and azelaic acid gel 15% are U.S. Food and Drug Administration-approved for the treatment of rosacea. The current study was conducted to assess the cumulative irritation potential of 2 formulations of metronidazole 0.75% gel and 1% gel--and azelaic acid gel 15% over 21 days (N=36). Results of this study demonstrated a significantly greater poten tial for irritation from azelaic acid compared with metronidazole gel 0.75% (P < .0001), which had significantly greater potential for irritation compared with metronidazole gel 1% (P = .0054). Metronidazole gel 1% had a similar profile to white petrolatum.
Colón
Luz E
LE
Galderma Laboratories, LP, Fort Worth, Texas, USA.
Johnson
Lori A
LA
Gottschalk
Ronald W
RW
D000287:Administration, Topical; D000328:Adult; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D003998:Dicarboxylic Acids / Q000008:administration & dosage / Q000009:adverse effects*; D003875:Drug Eruptions / Q000209:etiology*; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage / Q000009:adverse effects*; D008875:Middle Aged; D012393:Rosacea / Q000188:drug therapy*; D016037:Single-Blind Method
D003879:Dermatologic Agents; D003998:Dicarboxylic Acids; D005782:Gels; D008795:Metronidazole; C010038:azelaic acid