Efficacy and safety of azelaic acid (15%) gel as a new treatment for papulopustular rosacea: Results from two vehicle-controlled, randomized phase III studies

Diane Thiboutot, Ruth Thieroff-Ekerdt, Klaus Graupe

Research output: Contribution to journalArticle

128 Citations (Scopus)

Abstract

Background: Rosacea is a common, chronic dermatosis for which safe and effective new treatment options are needed. Objective: The objective of these studies was to evaluate the efficacy, tolerability, and safety of a new formulation of 15% azelaic acid (15%) gel (AzA gel), for the topical treatment of moderate, papulopustular rosacea. Methods: Two multicenter, double-blind, randomized, parallel-group, vehicle-controlled studies were conducted using identical study designs, patient-selection criteria, and efficacy end points. Overall, 329 patients were enrolled in study 1 and 335 patients in study 2. Results: Both studies consistently demonstrated the superiority of AzA gel over vehicle in the topical treatment of moderate, papulopustular rosacea. AzA gel yielded statistically significantly higher reductions in mean inflammatory lesion count than vehicle: 58% versus 40%, study 1 (P = .0001); 51% versus 39%, study 2 (P = .0208). Significantly higher proportions of patients treated with AzA gel experienced improvement in erythema compared with vehicle gel: 44% versus 29%, study 1 (P = .0017); 46% versus 28%, study 2 (P = .0005). Using the investigator's global assessment, therapeutic success in terms of a clear, minimal, or mild final result was achieved in 61% and 62% of patients treated with AzA gel in studies 1 and 2, respectively, which was significantly superior to the result achieved with vehicle (40% and 48%, respectively) (P < .0001, study 1; P = .0127, study 2). No serious, treatment-related adverse events were reported. Conclusion: The results of these 2 controlled studies demonstrate that AzA gel, used twice daily, is an efficacious, safe, and well-tolerated topical treatment for moderate, papulopustular rosacea.

Original languageEnglish (US)
Pages (from-to)836-845
Number of pages10
JournalJournal of the American Academy of Dermatology
Volume48
Issue number6
DOIs
StatePublished - Jun 1 2003

Fingerprint

Rosacea
Gels
Safety
Therapeutics
Patient Selection
azelaic acid
Erythema
Skin Diseases
Research Personnel

All Science Journal Classification (ASJC) codes

  • Dermatology

Cite this

@article{e508369e990848fd974344403df84db4,
title = "Efficacy and safety of azelaic acid (15{\%}) gel as a new treatment for papulopustular rosacea: Results from two vehicle-controlled, randomized phase III studies",
abstract = "Background: Rosacea is a common, chronic dermatosis for which safe and effective new treatment options are needed. Objective: The objective of these studies was to evaluate the efficacy, tolerability, and safety of a new formulation of 15{\%} azelaic acid (15{\%}) gel (AzA gel), for the topical treatment of moderate, papulopustular rosacea. Methods: Two multicenter, double-blind, randomized, parallel-group, vehicle-controlled studies were conducted using identical study designs, patient-selection criteria, and efficacy end points. Overall, 329 patients were enrolled in study 1 and 335 patients in study 2. Results: Both studies consistently demonstrated the superiority of AzA gel over vehicle in the topical treatment of moderate, papulopustular rosacea. AzA gel yielded statistically significantly higher reductions in mean inflammatory lesion count than vehicle: 58{\%} versus 40{\%}, study 1 (P = .0001); 51{\%} versus 39{\%}, study 2 (P = .0208). Significantly higher proportions of patients treated with AzA gel experienced improvement in erythema compared with vehicle gel: 44{\%} versus 29{\%}, study 1 (P = .0017); 46{\%} versus 28{\%}, study 2 (P = .0005). Using the investigator's global assessment, therapeutic success in terms of a clear, minimal, or mild final result was achieved in 61{\%} and 62{\%} of patients treated with AzA gel in studies 1 and 2, respectively, which was significantly superior to the result achieved with vehicle (40{\%} and 48{\%}, respectively) (P < .0001, study 1; P = .0127, study 2). No serious, treatment-related adverse events were reported. Conclusion: The results of these 2 controlled studies demonstrate that AzA gel, used twice daily, is an efficacious, safe, and well-tolerated topical treatment for moderate, papulopustular rosacea.",
author = "Diane Thiboutot and Ruth Thieroff-Ekerdt and Klaus Graupe",
year = "2003",
month = "6",
day = "1",
doi = "10.1067/mjd.2003.308",
language = "English (US)",
volume = "48",
pages = "836--845",
journal = "Journal of the American Academy of Dermatology",
issn = "0190-9622",
publisher = "Mosby Inc.",
number = "6",

}

TY - JOUR

T1 - Efficacy and safety of azelaic acid (15%) gel as a new treatment for papulopustular rosacea

T2 - Results from two vehicle-controlled, randomized phase III studies

AU - Thiboutot, Diane

AU - Thieroff-Ekerdt, Ruth

AU - Graupe, Klaus

PY - 2003/6/1

Y1 - 2003/6/1

N2 - Background: Rosacea is a common, chronic dermatosis for which safe and effective new treatment options are needed. Objective: The objective of these studies was to evaluate the efficacy, tolerability, and safety of a new formulation of 15% azelaic acid (15%) gel (AzA gel), for the topical treatment of moderate, papulopustular rosacea. Methods: Two multicenter, double-blind, randomized, parallel-group, vehicle-controlled studies were conducted using identical study designs, patient-selection criteria, and efficacy end points. Overall, 329 patients were enrolled in study 1 and 335 patients in study 2. Results: Both studies consistently demonstrated the superiority of AzA gel over vehicle in the topical treatment of moderate, papulopustular rosacea. AzA gel yielded statistically significantly higher reductions in mean inflammatory lesion count than vehicle: 58% versus 40%, study 1 (P = .0001); 51% versus 39%, study 2 (P = .0208). Significantly higher proportions of patients treated with AzA gel experienced improvement in erythema compared with vehicle gel: 44% versus 29%, study 1 (P = .0017); 46% versus 28%, study 2 (P = .0005). Using the investigator's global assessment, therapeutic success in terms of a clear, minimal, or mild final result was achieved in 61% and 62% of patients treated with AzA gel in studies 1 and 2, respectively, which was significantly superior to the result achieved with vehicle (40% and 48%, respectively) (P < .0001, study 1; P = .0127, study 2). No serious, treatment-related adverse events were reported. Conclusion: The results of these 2 controlled studies demonstrate that AzA gel, used twice daily, is an efficacious, safe, and well-tolerated topical treatment for moderate, papulopustular rosacea.

AB - Background: Rosacea is a common, chronic dermatosis for which safe and effective new treatment options are needed. Objective: The objective of these studies was to evaluate the efficacy, tolerability, and safety of a new formulation of 15% azelaic acid (15%) gel (AzA gel), for the topical treatment of moderate, papulopustular rosacea. Methods: Two multicenter, double-blind, randomized, parallel-group, vehicle-controlled studies were conducted using identical study designs, patient-selection criteria, and efficacy end points. Overall, 329 patients were enrolled in study 1 and 335 patients in study 2. Results: Both studies consistently demonstrated the superiority of AzA gel over vehicle in the topical treatment of moderate, papulopustular rosacea. AzA gel yielded statistically significantly higher reductions in mean inflammatory lesion count than vehicle: 58% versus 40%, study 1 (P = .0001); 51% versus 39%, study 2 (P = .0208). Significantly higher proportions of patients treated with AzA gel experienced improvement in erythema compared with vehicle gel: 44% versus 29%, study 1 (P = .0017); 46% versus 28%, study 2 (P = .0005). Using the investigator's global assessment, therapeutic success in terms of a clear, minimal, or mild final result was achieved in 61% and 62% of patients treated with AzA gel in studies 1 and 2, respectively, which was significantly superior to the result achieved with vehicle (40% and 48%, respectively) (P < .0001, study 1; P = .0127, study 2). No serious, treatment-related adverse events were reported. Conclusion: The results of these 2 controlled studies demonstrate that AzA gel, used twice daily, is an efficacious, safe, and well-tolerated topical treatment for moderate, papulopustular rosacea.

UR - http://www.scopus.com/inward/record.url?scp=0038793699&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0038793699&partnerID=8YFLogxK

U2 - 10.1067/mjd.2003.308

DO - 10.1067/mjd.2003.308

M3 - Article

C2 - 12789172

AN - SCOPUS:0038793699

VL - 48

SP - 836

EP - 845

JO - Journal of the American Academy of Dermatology

JF - Journal of the American Academy of Dermatology

SN - 0190-9622

IS - 6

ER -