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Evalulation of Azelaic Acid for Non-Prescription Use

Evalulation of Azelaic Acid for Non-Prescription Use. Michelle Brown Andy Reynolds Ted Williams Pharm. D candidates, OSU College of Pharmacy. Search Strategy. Relied primarily on MedLine search Used tertiary resources at the discretions of the author One dermatologist interview. Diseases.

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Evalulation of Azelaic Acid for Non-Prescription Use

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  1. Evalulation of Azelaic Acid for Non-Prescription Use Michelle Brown Andy Reynolds Ted Williams Pharm. D candidates, OSU College of Pharmacy

  2. Search Strategy • Relied primarily on MedLine search • Used tertiary resources at the discretions of the author • One dermatologist interview

  3. Diseases • Mild to Moderate Acne Vulgaris • Rosacea • Melasma

  4. Disease State Definition • Acne • chronic inflammatory disease of the pilosebaceous units in the dermis • Pilosebaceous unit location • Mainly face, back and chest • Also neck and upper arms

  5. Disease State Causes • Causes of Acne • Exact causes unknown • 4 factors involved • Excessive Sebum produced • Hyperkeratinization of the hair follicle • Prevents shedding of the follicular keratinocytes • Leads to the formation of microscopic lesions microcomedo • Accumulation of lipids and cellular debris • Colonization by Propionibacterium acnes

  6. Disease State Progression • Normal Follicle

  7. Disease State Progression • Microcomedo

  8. Disease State Progression • Open Comedo • “Blackhead”

  9. Disease State Progression • Closed Comedo • “Whitehead”

  10. Disease State Progression • Papule • Enflamed lesion

  11. Disease State Progression • Pustule • Enlarged papule • Pus filled • Raised • Reddened

  12. Disease State Progression • Nodule (or Cyst) • Inflammation penetrates deeper into skin • May lead to scarring or pitting

  13. Disease State Classification • Defined by American Academy of Dermatology • Mild Acne • A few to several papules or pustules • Moderate Acne • Several to many papules and pustules along with several nodules • Severe Acne • Numerous or extensive papules and pustules as well as many nodules

  14. Drug Information • Drug Requested • Pharmacology • Dose • Indications • Pharmacokinetics • Side Effects

  15. Efficacy • Demonstrated effective vs. no treatment • Demonstrated effective vs. other topicals (benzoyl peroxide) • Demonstrated effective vs. oral treatments (tetracycline) • Effective in combinations with other topicals (Glycolic Acid) and oral treatments (minocycline)

  16. Safety • Low systemic absorption • FDA Pregnancy category B • Not passed in lactation in above baseline levels • Good option for pregnant patients vs. oral treatments • No known drug interactions

  17. Cost

  18. Conclusions • Effective • Safe • No known Interactions • Low Pregnancy Risk • Elevated Cost vs. Benzoyl Peroxide • Recommended for OTC Use

  19. References • Facts and Comparisons 4.0 Available from URL:Online http://online.factsandcomparisons.com/ • Goulden, V. Guidelines for the Management of Acne Vulgaris in Adolescents. Pediatric Drugs 2003;5(5):301-313 • Feldman, S, Careccia R, Barham K, Hancox J. Diagnosis and Treatment of Acne.. American Family Physician 2004;69:2123-30 • Thiboutot D. New Treatments and Therapeutic Strategies for Acne Treatment. Archives of Family Medicine 2000;9:179-187. Berardi R, McDermott J, Newton G, Oszko M, Popovich N, Rollims C, et al. Handbook of Nonprescription Drugs 2004;913-927. • The Red Book, (2003). • Arash Akhaven and Susan Bershad, “Topical Acne Drugs; Review of Clinical Properties, Systemic Exposure, and Safety,” Am J Clin Dermatol 2003, 4(7): 473-492. • Mackrides, P S, Shaughnessy A F, “Azelaic Acid Therapy for Acne,” American Family Physician 1996, 54(8): 2457-2459. • Spellman M.C. and Pincus, S.H., “Efficacy and Safety of Azelaic Acid and Glycolic Acid Combination Therapy Compared with Tretinoin Therapy for Acne,” Clinical Therapeutics 1998, 20(4): 711-720. • Physician’s Desk Reference 2005, 59th ed.: 907-908. • Drug Information Handbook 2005, 13th ed: 165-166. • RxList The Internet Drug Index on the web at http://www.rxlist.com/cgi/pharmclips.cgi?keyword=AZELEX (last accessed Nov. 28, 2005). • Nazzaro-Porro, M., Passai, S., Picardo, M., Breathnach, A., Clayton, R. Zina, G., Beneficial effect of 15% azelaic acid cream on acne vulgaris. British Journal of Dermatology (1983) 109:45-48 • Cavicchini, S., Caputo, R. Long-term Treatment of Acne with 20% Azelaic Acid Cream. Acta Dermato-Venereologica (1989) Suppliment 143:40-44 • Hjorth, N., Graupe, K. Azelaic Acid for the Treatment of Acne: A Clinical comparison with Oral Tetracycline. Acta Derm Venereologica (1989) Suppliment 143:45-48 • Spellmajn, M.C., Pincus, S. H. Efficacy and Safety of Azelaic Acid and Glycolic Acid Combination Therapy Compared with Tretinoin Therapy for Acne. Clinical Therapeutics (1998) 20:4 711-720 • Gollinick, H. P. M., Graupe, K., Zaumseil. Comparison of combined azelaic acid cream plus oral minocycline with oral isotretinoin in severe acne. European Journal Dermatology (2001) 11:538-44. • Gass, S. Expert opinion of a practicing dermatologist.

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