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A comparison of 15% azelaic acid gel and 0.75% metronidazole gel in the topical treatment of papulopustular rosacea: results of a randomized trial.
Arch Dermatol. 2003 Nov; 139(11):1444-50.AD

Abstract

OBJECTIVE

To compare the efficacy and safety of a novel formulation of 15% azelaic acid gel (Finacea; Berlex Laboratories, Inc, Montville, NJ) with 0.75% metronidazole gel (MetroGel; Galderma Laboratories LP, Fort Worth, Tex) as topical therapy for moderate, papulopustular facial rosacea.

DESIGN

Multicenter, double-blind, randomized, parallel-group study.

SETTING

Thirteen US centers.

PATIENTS

A total of 251 patients with papulopustular rosacea with persistent erythema and telangiectasia.

INTERVENTIONS

Patients were randomized to receive azelaic acid gel or metronidazole gel twice daily for 15 weeks.

MAIN OUTCOME MEASURES

Nominal and percent change in inflammatory lesion count, change in erythema and telangiectasia severity ratings, investigator's global assessment of rosacea, and investigator's and patient's overall improvement ratings.

RESULTS

Azelaic acid gel was superior to metronidazole gel in reduction of mean nominal lesion count (-12.9 vs -10.7, respectively) (P =.003) and mean percent decrease in inflammatory lesions (-72.7% vs -55.8%, respectively) (P<.001). With respect to erythema severity, 56% of azelaic acid gel-treated patients were rated improved vs 42% of metronidazole gel-treated patients (P =.02). The effectiveness of metronidazole gel on these variables seemed to plateau after week 8, whereas azelaic acid gel demonstrated progressive improvement through week 15. Neither treatment had a clinically appreciable effect on telangiectasia. Both the investigator's global assessment (P =.02) and overall assessment of improvement (P =.005) showed a significant therapeutic advantage for azelaic acid gel. Azelaic acid gel also scored higher on the patient's overall assessment of efficacy. Both treatments were rated as having high cosmetic acceptability. No serious or systemic treatment-related adverse events were reported in either group.

CONCLUSION

Use of 15% azelaic acid gel twice daily for 15 weeks demonstrated significant superiority over using 0.75% metronidazole gel in improving principal signs of rosacea (inflammatory lesions and erythema).

Authors+Show Affiliations

Elewski BE
Department of Dermatology, University of Alabama at Birmingham, 35233, USA. beelewski@aol.com
Fleischer AB
No affiliation info available
Pariser DM
No affiliation info available

MeSH

Administration, TopicalAdultAgedAged, 80 and overDermatologic AgentsDicarboxylic AcidsDouble-Blind MethodErythemaFemaleGelsHumansMaleMetronidazoleMiddle AgedOsmolar ConcentrationPatient SatisfactionRosaceaTelangiectasisTreatment Outcome

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

14623704

Citation

Elewski, Boni E., et al. "A Comparison of 15% Azelaic Acid Gel and 0.75% Metronidazole Gel in the Topical Treatment of Papulopustular Rosacea: Results of a Randomized Trial." Archives of Dermatology, vol. 139, no. 11, 2003, pp. 1444-50.
Elewski BE, Fleischer AB, Pariser DM. A comparison of 15% azelaic acid gel and 0.75% metronidazole gel in the topical treatment of papulopustular rosacea: results of a randomized trial. Arch Dermatol. 2003;139(11):1444-50.
Elewski, B. E., Fleischer, A. B., & Pariser, D. M. (2003). A comparison of 15% azelaic acid gel and 0.75% metronidazole gel in the topical treatment of papulopustular rosacea: results of a randomized trial. Archives of Dermatology, 139(11), 1444-50.
Elewski BE, Fleischer AB, Pariser DM. A Comparison of 15% Azelaic Acid Gel and 0.75% Metronidazole Gel in the Topical Treatment of Papulopustular Rosacea: Results of a Randomized Trial. Arch Dermatol. 2003;139(11):1444-50. PubMed PMID: 14623704.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A comparison of 15% azelaic acid gel and 0.75% metronidazole gel in the topical treatment of papulopustular rosacea: results of a randomized trial. AU - Elewski,Boni E, AU - Fleischer,Alan B,Jr AU - Pariser,David M, PY - 2003/11/19/pubmed PY - 2003/12/5/medline PY - 2003/11/19/entrez SP - 1444 EP - 50 JF - Archives of dermatology JO - Arch Dermatol VL - 139 IS - 11 N2 - OBJECTIVE: To compare the efficacy and safety of a novel formulation of 15% azelaic acid gel (Finacea; Berlex Laboratories, Inc, Montville, NJ) with 0.75% metronidazole gel (MetroGel; Galderma Laboratories LP, Fort Worth, Tex) as topical therapy for moderate, papulopustular facial rosacea. DESIGN: Multicenter, double-blind, randomized, parallel-group study. SETTING: Thirteen US centers. PATIENTS: A total of 251 patients with papulopustular rosacea with persistent erythema and telangiectasia. INTERVENTIONS: Patients were randomized to receive azelaic acid gel or metronidazole gel twice daily for 15 weeks. MAIN OUTCOME MEASURES: Nominal and percent change in inflammatory lesion count, change in erythema and telangiectasia severity ratings, investigator's global assessment of rosacea, and investigator's and patient's overall improvement ratings. RESULTS: Azelaic acid gel was superior to metronidazole gel in reduction of mean nominal lesion count (-12.9 vs -10.7, respectively) (P =.003) and mean percent decrease in inflammatory lesions (-72.7% vs -55.8%, respectively) (P<.001). With respect to erythema severity, 56% of azelaic acid gel-treated patients were rated improved vs 42% of metronidazole gel-treated patients (P =.02). The effectiveness of metronidazole gel on these variables seemed to plateau after week 8, whereas azelaic acid gel demonstrated progressive improvement through week 15. Neither treatment had a clinically appreciable effect on telangiectasia. Both the investigator's global assessment (P =.02) and overall assessment of improvement (P =.005) showed a significant therapeutic advantage for azelaic acid gel. Azelaic acid gel also scored higher on the patient's overall assessment of efficacy. Both treatments were rated as having high cosmetic acceptability. No serious or systemic treatment-related adverse events were reported in either group. CONCLUSION: Use of 15% azelaic acid gel twice daily for 15 weeks demonstrated significant superiority over using 0.75% metronidazole gel in improving principal signs of rosacea (inflammatory lesions and erythema). SN - 0003-987X UR - https://www.unboundmedicine.com/medline/citation/14623704/A_comparison_of_15_azelaic_acid_gel_and_0_75_metronidazole_gel_in_the_topical_treatment_of_papulopustular_rosacea:_results_of_a_randomized_trial_ DB - PRIME DP - Unbound Medicine ER -