Azelaic acid foam 15% in the treatment of papulopustular rosacea: A randomized, double-blind, vehicle-Controlled study

Cutis

Volumn 92, Issue 6, 2013, Pages 306-317

  Draelos, Zoe Diana ^a,c   Elewski, Boni ^b,d   Staedtler, Gerald ^c   Havlickova, Blanka ^c  

^a DERMATOLOGY CONSULTING SERVICES   (United States)

^b UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^c BAYER PHARMA AG   (Germany)

^d Bayer HealthCare Pharmaceuticals and Galderma Laboratories   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AZELAIC ACID; DERMATOLOGICAL AGENT; DICARBOXYLIC ACID;

ADULT; AGED; ARTICLE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; FEMALE; FOLLOW UP; HUMAN; INTRADERMAL DRUG ADMINISTRATION; MALE; MIDDLE AGED; MULTICENTER STUDY; PATHOLOGY; RANDOMIZED CONTROLLED TRIAL; ROSACEA; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; VERY ELDERLY; YOUNG ADULT;

ADMINISTRATION, CUTANEOUS; ADULT; AGED; AGED, 80 AND OVER; DERMATOLOGIC AGENTS; DICARBOXYLIC ACIDS; DOUBLE-BLIND METHOD; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; ROSACEA; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84891637405     PISSN: 00114162     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (53)

1. Drake L. Rosacea now estimated to affect at least 16 million Americans. Rosacea Review. Winter 2010. http://www.rosacea.org/rr/2010/winter/article_1.php/. Accessed November 25, 2013.
2. Yamasaki K, Gallo RL. The molecular pathology of rosacea [published online ahead of print May 29, 2009]. J Dermatol Sci. 2009;55:77-81.
3. Abram K, Silm H, Maaroos HI, et al. Subjective disease perception and symptoms of depression in relation to healthcare-seeking behaviour in patients with rosacea. Acta Derm Venereol. 2009;89:488-491.
4. Powell FC. Epidemiologic data, triggering factors and clinical stages of rosacea. J Eur Acad Dermatol Venereol. 1998;11:S107.
5. Kyriakis KP, Palamaras I, Terzoudi S, et al. Epidemiologic aspects of rosacea. J Am Acad Dermatol. 2005;53:918-919.
6. Gupta MA, Gupta AK, Chen SJ, et al. Comorbidity of rosacea and depression: an analysis of the National Ambulatory Medical Care Survey and National Hospital Ambulatory Care Survey: Outpatient Department Data collected by the U.S. National Center for Health Statistics from 1995 to 2002. Br J Dermatol. 2005;153:1176-1181.
7. Berg M, Lidén S. An epidemiological study of rosacea. Acta Derm Venereol. 1989;69:419-423.
8. Bollag WB, Dodd ME, Shapiro BA. Protein kinase D and keratinocyte proliferation. Drug News Perspect. 2004;17:117-126.
9. Li J, O'Reilly N, Sheha H, et al. Correlation between ocular Demodex infestation and serum immunoreactivity to Bacillus proteins in patients with facial rosacea [published online ahead of print January 15, 2010]. Ophthalmology. 2010;117:870.e1-877.e1.
10. Wilkin J, Dahl M, Detmar M, et al. Standard grading system for rosacea: report of the National Rosacea Society Expert Committee on the classification and staging of rosacea. J Am Acad Dermatol. 2004;50:907-912.
11. Wilkin J, Dahl M, Detmar M, et al. Standard classification of rosacea: report of the National Rosacea Society Expert Committee on the classification and staging of rosacea. J Am Acad Dermatol. 2002;46:584-587.
12. Mortensen PB. Dicarboxylic acids and the lipid metabolism. Dan Med Bull. 1984;31:121-145.
13. Breathnach AS. Melanin hyperpigmentation of skin: melasma, topical treatment with azelaic acid, and other therapies. Cutis. 1996;57(suppl 1):36-45.
14. Yamasaki K, Gallo RL. Azelaic acid (AzA) gel 15% decreases kallikrein 5 in epidermal keratinocytes: critical elements in production of cathelicidin and the pathogenesis of rosacea. Poster presented at: 68th Annual Meeting of the American Academy of Dermatology; March 5-9, 2010; Miami Beach, FL.
15. Draelos Z. Multiple mechanisms of action of azelaic acid: new findings. Poster presented at: 67th Annual Meeting of the American Academy of Dermatology; March 6-10, 2009; San Francisco, CA.
16. Brasch J, Christophers E. Azelaic acid has antimycotic properties in vitro. Dermatology. 1993;186:55-58.
17. Leeming JP, Holland KT, Bojar RA. The in vitro antimicrobial effect of azelaic acid. Br J Dermatol. 1986;115:551-556.
18. Bojar RA, Holland KT, Cunliffe WJ. The in-vitro antimicrobial effects of azelaic acid upon Propionibacterium acnes strain P37. J Antimicrob Chemother. 1991;28:843-853.
19. Maple PA, Hamilton-Miller JM, Brumfitt W. Comparison of the in-vitro activities of the topical antimicrobials azelaic acid, nitrofurazone, silver sulphadiazine and mupirocin against methicillin-resistant Staphylococcus aureus. J Antimicrob Chemother. 1992;29:661-668.
20. Bojar RA, Holland KT, Leeming JP, et al. Azelaic acid: its uptake and mode of action in Staphylococcus epidermidis NCTC 11047. J Appl Bacteriol. 1988;64:497-504.
21. Bojar RA, Cunliffe WJ, Holland KT. Disruption of the transmembrane pH gradient-a possible mechanism for the antibacterial action of azelaic acid in Propionibacterium acnes and Staphylococcus epidermidis. J Antimicrob Chemother. 1994;34:321-330.
22. Mayer-da Silva A, Gollnick H, Imcke E, et al. Azelaic acid vs. placebo: effects on normal human keratinocytes and melanocytes. electron microscopic evaluation after long-term application in vivo. Acta Derm Venereol. 1987;67:116-122.
23. Mayer-da-Silva A, Gollnick H, Detmar M, et al. Effects of azelaic acid on sebaceous gland, sebum excretion rate and keratinization pattern in human skin. an in vivo and in vitro study. Acta Derm Venereol Suppl (Stockh). 1989;143:20-30.
24. Gupta AK, Gover MD, Nouri K, et al. The treatment of melasma: a review of clinical trials [published online ahead of print September 28, 2006]. J Am Acad Dermatol. 2006;55:1048-1065.
25. Czernielewski J, Liu Y. Comparison of 15% azelaic acid gel and 0.75% metronidazole gel for the topical treatment of papulopustular rosacea. Arch Dermatol. 2004;140:1282-1283; author reply 1283.
26. Frampton JE, Wagstaff AJ. Azelaic acid 15% gel: in the treatment of papulopustular rosacea. Am J Clin Dermatol. 2004;5:57-64.
27. Elewski BE, Fleischer AB Jr, 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. Archives Dermatol. 2003;139:1444-1450.
28. Thiboutot D, Thieroff-Ekerdt R, Graupe K. Efficacy and safety of azelaic acid (15%) gel as a new treatment for papulopustular rosacea: results from two vehicle-controlled, randomized phase III studies. J Am Acad Dermatol. 2003;48:836-845.
29. Gollnick H, Layton A. Azelaic acid 15% gel in the treatment of rosacea. Expert Opin Pharmacother. 2008;9:2699-2706.
30. Thiboutot DM, Fleischer AB Jr, Del Rosso JQ, et al. Azelaic acid 15% gel once daily versus twice daily in papulopustular rosacea. J Drugs Dermatol. 2008;7:541-546.
31. Del Rosso JQ, Baum EW, Draelos ZD, et al. Azelaic acid gel 15%: clinical versatility in the treatment of rosacea. Cutis. 2006;78(suppl 5):6-19.
32. Elewski BE. Rosacea trial comparing twice-daily azelaic acid gel 15% with once-daily metronidazole gel 1%. Cutis. 2007;79:57-58.
33. Finacea Gel [package insert]. Wayne, NJ: Bayer HealthCare Pharmaceuticals Inc; 2012.
34. Abramova L, Yeung J, Chren MM, et al. Rosacea quality of life index (RosaQoL). J Am Acad Dermatol. 2004;50(suppl):P12.
35. Nazzaro-Porro M. Azelaic acid. J Am Acad Dermatol. 1987;17:1033-1041.
36. Jones DA. Rosacea, reactive oxygen species, and azelaic acid. J Clin Aesthet Dermatol. 2009;2:26-30.
37. Passi S, Picardo M, Zompetta C, et al. The oxyradical-scavenging activity of azelaic acid in biological systems. Free Radic Res Commun. 1991;15:17-28.
38. Schallreuter KU, Wood JW. A possible mechanism of action for azelaic acid in the human epidermis. Arch Dermatol Res. 1990;282:168-171.
39. Akamatsu H, Komura J, Asada Y, et al. Inhibitory effect of azelaic acid on neutrophil functions: a possible cause for its efficacy in treating pathogenetically unrelated diseases. Arch Dermatol Res. 1991;283:162-166.
40. Thiboutot DM, Fleischer AB, Del Rosso JQ, et al. A multicenter study of topical azelaic acid 15% gel in combination with oral doxycycline as initial therapy and azelaic acid 15% gel as maintenance monotherapy. J Drugs Dermatol. 2009;8:639-648.
41. Mostafa FF, El Harras MA, Gomaa SM, et al. Comparative study of some treatment modalities of rosacea. J Eur Acad Dermatol Venereol. 2009;23:22-28.
42. Reid DC, Kimball AB. Clobetasol propionate foam in the treatment of psoriasis. Expert Opin Pharmacother. 2005;6:1735-1740.
43. Bergstrom KG, Arambula K, Kimball AB. Medication formulation affects quality of life: a randomized single-blind study of clobetasol propionate foam 0.05% compared with a combined program of clobetasol cream 0.05% and solution 0.05% for the treatment of psoriasis. Cutis. 2003;72:407-411.
44. Feldman SR, Housman TS. Patients' vehicle preference for corticosteroid treatments of scalp psoriasis. Am J Clin Dermatol. 2003;4:221-224.
45. Gottlieb AB, Ford RO, Spellman MC. The efficacy and tolerability of clobetasol propionate foam 0.05% in the treatment of mild to moderate plaque-type psoriasis of nonscalp regions. J Cutan Med Surg. 2003;7:185-192.
46. Housman TS, Mellen BG, Rapp SR, et al. Patients with psoriasis prefer solution and foam vehicles: a quantitative assessment of vehicle preference. Cutis. 2002;70:327-332.
47. Purdon CH, Haigh JM, Surber C, et al. Foam drug delivery in dermatology: beyond the scalp. Am J Drug Deliv. 2003;1:71-75.
48. Shalita AR, Myers JA, Krochmal L, et al. The safety and efficacy of clindamycin phosphate foam 1% versus clindamycin phosphate topical gel 1% for the treatment of acne vulgaris. J Drugs Dermatol. 2005;4:48-56.
49. Tamarkin D, Friedman D, Shemer A. Emollient foam in topical drug delivery. Expert Opin Drug Deliv. 2006;3:799-807.
50. van Zuuren EJ, Kramer SF, Carter BR, et al. Effective and evidence-based management strategies for rosacea: summary of a Cochrane systematic review [published online ahead of print September 15, 2011]. Br J Dermatol. 2011;165:760-781.
51. Parodi A, Drago F, Paolino S, et al. Treatment of rosacea. Ann Dermatol Venereol. 2011;138 (suppl 3):S211-S214.
52. Jackson JM, Pelle M. Topical rosacea therapy: the importance of vehicles for efficacy, tolerability and compliance. J Drugs Dermatol. 2011;10:627-633.
53. Wolf JE Jr. Medication adherence: a key factor in effective management of rosacea. Adv Ther. 2001;18:272-281.