The Efficacy and Safety of Azelaic Acid 15% Foam in the Treatment of Facial Acne Vulgaris

June 2018 | Volume 17 | Issue 6 | Original Article | 641 | Copyright © June 2018

Peter W. Hashim MD MHS,a Tinley Chen BA,a Julie C. Harper MD,b and Leon H. Kircik MDa,c,d

aThe Icahn School of Medicine at Mount Sinai, Department of Dermatology, New York, NY bThe Dermatology and Skin Care Center of Birmingham, Birmingham, AL cIndiana University School of Medicine, Indianapolis, IN dPhysicians Skin Care PLLC, Louisville, KY

Table 6sinus infection. One serious adverse event of bronchitis, moderate severity, was reported and determined to be unrelated to study medication. No therapy was initiated, and the event resolved with no residual effects. 


Over a 16-week period, treatment with azelaic acid 15% foam led to decreases in the number of total, inflammatory, and non-inflammatory lesions in subjects with moderate-to-severe facial acne. Subjects showed an average 77% reduction in inflammatory lesion counts, 64% reduction in non-inflammatory lesion counts, and 73% reduction in total lesion counts. Reductions in lesion counts were supported by static physician assessments of facial severity, with a majority of subjects rated as “clear” or “almost clear” by the conclusion of the study. Azelaic acid 15% foam was well-tolerated on the facial area, and questionnaire results indicated that subjects viewed the foam vehicle as easily applicable and cosmetically appealing. Future research should expand upon this work in larger sample sizes and with vehicle control as well as active comparators. This study establishes azelaic acid 15% foam as a promising, safe, and efficacious therapy option for patients with moderate-to-severe facial acne. 


Dr. Hashim and Tinley Chen have no conflicts of interest to disclose. Dr. Harper is a consultant, researcher, and speaker for Bayer HealthCare Pharmaceuticals Inc. Dr. Kircik has served as an advisor, investigator, consultant, and speaker for Allergan, Bayer, Galderma, Promius Pharma, Sun Pharma, Stiefel/GSK, LeoPharma, Taro, Valeant, and Warner-Chilcott. This study was funded by Bayer as an investigator-initiated study. 


  1. Plewig G, Kligman AM: Acne and rosacea, ed 3. Berlin Springer, 2000.
  2. Williams C, Layton AM. Persistent acne in women : implications for the patient and for therapy. Am J Clin Dermatol. 2006;7(5):281-90.
  3. Zeichner JA, Baldwin HE, Cook-Bolden FE, et al. Emerging Issues in Adult Female Acne. J Clin Aesthet Dermatol. 2017 Jan;10(1):37-46. Epub 2017 Jan 1.
  4. Toyoda M, Morohashi M. Pathogenesis of acne. Med Electron Microsc. 2001 Mar;34(1):29-40.
  5. Sieber MA, Hegel JKE. Azelaic acid: properties and mode of action. Skin Pharmacol Physiol. 2014;27(Suppl 1):9–17.
  6. Gupta, A. K. and Gover, M. D. (2007), Azelaic acid (15% gel) in the treatment of acne rosacea. Int J Dermatol. 46: 533–538. doi:10.1111/j.1365-4632.2005.02769.x
  7. Allergan, Inc. Azelex® Cream, 20% (package insert), 2015.
  8. Gollnick HPM, Graupe K, Zaumseil R-P. Azelaic acid 15% gel in the treatment of acne vulgaris. Combined results of two double-blind clinical comparative studies. J Dtsch Dermatol Ges J Ger Soc Dermatol. 2004;2(10):841–847. 
  9. 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.
  10. Draelos ZD, Elewski BE, Harper JC, Sand M, Staedtler G, Nkulikiyinka R, et al. A phase 3 randomized, double-blind, vehicle-controlled trial of azelaic acid foam 15% in the treatment of papulopustular rosacea. Cutis. 2015;96(1):54–61.
  11. Bayer HealthCare Pharmaceuticals Inc. Finacea® Foam, 15% (package insert), 2015.
  12. Draelos ZD. The rationale for advancing the formulation of azelaic acid vehicles. Cutis. 2006;77(2 Suppl):7–11.
  13. Del Rosso, J.Q. Using a foam vehicle for dermatologic applications. The Dermatologist. 2002;10.


Leon H. Kircik MD