title: Cumulative irritation potential among metronidazole gel 1%, metronidazole gel 0.75%, and azelaic acid gel 15%.
abstract: 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.
authors.affiliation: Galderma Laboratories, LP, Fort Worth, Texas, USA.
authors.forename: Luz E
authors.initials: LE
authors.lastname: Colón
authors.forename: Lori A
authors.initials: LA
authors.lastname: Johnson
authors.forename: Ronald W
authors.initials: RW
authors.lastname: Gottschalk
mesh_terms: 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
chemical_list: D003879:Dermatologic Agents; D003998:Dicarboxylic Acids; D005782:Gels; D008795:Metronidazole; C010038:azelaic acid