1. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Division of Surgical Devices. Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails (HFA-305). Issued on January 27, 2015.
  2. Haria M, Bryson H. Amorolfine. A Review of its Pharmacological Properties and Therapeutic Potential in the Treatment of Onychomycosis and Other Superficial Fungal Infections. Drugs 1995; 49(1): 103-120.
  3. Polak A, Zaug M. Amorolfine. Handbook of Experimental Pharmacology, vol. 96: Chemotherapy of Fungal Diseases 1990; 504-521
  4. Baran R, Kaoukhov A. Topical antifungal drugs for the treatment of onychomycosis: an overview of current strategies for monotherapy and combination therapy. JEADV 2005; 19: 21-29.
  5. Pittrof F, Gerhards J, Erni W, et al. Loceryl® nail lacquer—realization of a new galenical approach to onychomycosis therapy. Clinical and Experimental Dermatology 1992; 17 (Suppl. 1): 26-28.
  6. Faergemann J, Baran R. Epidemiology, clinical presentation and diagnosis of onychomycosis. British Journal of Dermatology 2003; 149 (Suppl. 65): 1-4.
  7. Effendy I, Lecha M, Feuilhade de Chauvin M, et al. Epidemiology and clinical classification of onychomycosis. JEADV 2005; 19 (Suppl. 1): 8-12.
  8. Monod M. Secreted Proteases from Dermatophytes. Mycopathologia 2008; 166: 285-294.
  9. Szepietowski J, Reich A, Garlowska E, et al. Factors Influencing Coexistence of Toenail Onychomycosis With Tinea Pedis and Other Dermatomycoses. Arch Dermatol. 2006; 142: 1279-1284.
  10. Elewski B. Onychomycosis: Pathogenesis, Diagnosis, and Management. Clinical Microbiology Reviews 1998; 11(3): 415-429
  11. Hay R, Baran R. Onychomycosis: A proposed revision of the clinical classification. J Am Acad Dermatol 2011; 65(6): 1219-1227.
  12. Tosti A, Hay R, Arenas-Guzmán R. Patients at risk of onychomycosis — risk factor identification and active prevention. JEADV 2005; 19(Suppl. 1): 13-16.
  13. Baran R, Hay R, Garduno J. Review of antifungal therapy and the severity index for assessing onychomycosis: Part 1. Journal of Dermatological Treatment 2008; 19: 72-81.
  14. Polak A, Amorolfine: A Review of its Mode of Action and In Vitro and In Vivo Antifungal Activity. JAMA-SEA 1993; 11-18.
  15. Loceryl® Nail Lacquer 5 % Summary of Product Characteristics Updated 13-Jan-2014.
  16. Gupta A, Daigle D. Foley K. Topical therapy for toenail onychomycosis: an evidence-based review. Am J Clin Dermatol 2014; 15(8): 489-502
  17. Polak A, Jäckel A, Noack A, et al. Agar sublimations test for the in vitro determination of the antifungal activity of morpholine derivatives. Blackwell Publishing Ltd. Mycoses 2004; 47: 184-192
  18. Ghannoum M, Sevin K, Sarkany M. Amorolfine 5% Nail Lacquer Exhibits Potent Antifungal Activity Compared to Three Acid-Based Devices Indicated for the Treatment of Onychomycosis: An In Vitro Nail Penetration Assay. Dermatol Ther. DOI 10.1007/s13555-016-0093-x.
  19. Yaemsiri S, Hou N, Slining M, et al. Growth rate of human fingernails and toenails in healthy American young adults. J Eur Acad Dermatol Venereol 2010; 24(4): 420-423.
  20. Data on file – Galderma Laboratories.
  21. Data on file – Galderma Laboratories.
  22. Lecha M, Effendy I, Geuilhade de Chauvin M, et al. Treatment options – development of consensus guidelines. JEADV 2005; 19 (Suppl 1):25-33.

LOC 1611-05. Final approval date: 20/11/17