The Clinical Relevance and Therapeutic Benefit of Established Active Ingredients Incorporated into Advanced Foam Vehicles: Vehicle Characteristics Can Influence and Improve Patient Outcomes

February 2019 | Volume 18 | Issue 2 | Supplement Individual Articles | 100 | Copyright © February 2019


James Q. Del Rosso DO,Ma Leon Kircik MD,b Joshua Zeichner MD,c Linda Stein Gold MDd

aJDR Dermatology Research/Thomas Dermatology, Las Vegas, NV; Touro University, Henderson, NV bIcahn School of Medicine at Mount Sinai, New York, NY cIcahn School of Medicine at Mount Sinai, New York, NY dHenry Ford Hospital, Detroit, MI

Take Home Observations and Concluding Remarks
  • It is important that CalcipF and TazF be stored appropriately away from excessive heat. As the propellant in these foams is flammable, the patient is to avoid proximity to flames, fire, and smoking during dispensing and application of the foam.24,25 
  • Foam formulations were first used as vehicles for TCS for disease states that often affected large body surface areas. Additionally, some foams were associated with skin dryness and irritation due to their hydroethanolic base. As a result, the positioning of foam vehicles in the minds of clinicians has unfortunately led to use limited to widespread disease due to spreadability, and/or avoidance of facial use due to concerns about irritation or lack of familiarity with proper methods of application. The favorable tolerability and delivery properties of the aqueous foams provides greater adaptability for localized or widespread use, including facial application.
  • To improve facial application of a foam vehicle and avoid waste, it is suggested that a small amount be applied to the top of the foam cannister cap. The lead author recommends that the tip of the finger be used to transfer the foam by spot application to six points on the face: right forehead, left forehead, right mid cheek, left mid cheek, chin, and lower nose dorsum. The fingers can then be used to confluently connect the spots of application by gentle circular motion to provide even and diffuse facial application, with avoidance of the eyelids and lips.
  • The risk of calcipotriene use during pregnancy is not fully established and should be used only if the potential benefit justifies the potential risk.24 
  • Patients should avoid exposure to natural sunlight, artificial ultraviolet (UV) light, or application prior to phototherapy when using CaciplF due to instability and breakdown of calcipotriene upon exposure to UV light.24,42 Calcioptriene may also be broken down and inactivated when applied concurrently with acidic pH products such as salicyclic acid, lactic acid, and some TCS.43 
  • The risk of clinically relevant hypercalcemia is very low with topical calcipotriene use.34,35 
  • Product labeling with calcipotriene suggests avoidance of use in patients with known hypercalcemia.24,28-30 
  • Topical tazarotene in contraindicated in pregnancy. Females of child-bearing potential should be instructed to use adequate birth control measures when using tazarotene.25,39-41 
  • Patients should be instructed regarding potential for visible
  • and/or symptomatic ASRs when using a topical retinoid for AV, including TazF. Gentle skin care including moisturizer use may be needed to ameliorate local skin reactions.39-41 
  • Space limitations preclude the ability to cover all of information in product labeling and pivotal study publications. It is recommended that the reader review the package inserts for CalcipF and TazF, including storage recommendations, application instructions, patient information, and important safety information.24,25 

    • DISCLOSURE

    Drs. Del Rosso, Kircik, and Stein Gold have served as advisors and speakers for Mayne Pharma. Dr. Zeichner has served as a consultant for Mayne Pharma.

    REFERENCES

    1. Kircik L. Vehicles matter. J Drugs Dermatol. 2018;17(6):s4-s5.
    2. Warner MR, Camisa C. Topical corticosteroids: In: Wolverton SE, Editor, Comprehensive Dermatologic Drug Therapy, 3rd Edition, Saunders-Elsevier, Philadelphia, PA, USA, 2013:487-504.
    3. Surber C, Tassopoulos T. Ointments, creams, and lotions used as topical drug delivery vehicles. In: Bronaugh RL, Maibach HI, eds, Marcel-Dekker Inc, New York, NY, USA, 2002:511-517.
    4. Shah VP, Elkins JS, Williams RL. Importance of in vitro release measurement in topical dermatological dosage forms. In: Bronaugh RL, Maibach HI, eds, Marcel-Dekker Inc, New York, NY, USA, 2002:283-297.
    5. Felix K, Unrue E, Inyang M, et al. Patient preferences for different corticosteroid vehicles are highly variable. J Dermatolog Treat. 2018;17:1-18.
    6. Warino L, Balkrishnan R, Feldman SR. Clobetasol propionate for psoriasis: are ointments really more potent. J Drugs Dermatol. 2006;5(6):527-532.
    7. Del Rosso JQ. Moisturizer and barrier repair formulations. In: Draelos ZD, Ed, Cosmeceuticals, 3rd Edition, Elsevier, Philadelphia, PA, USA, 2016:81-89.
    8. Del Rosso JQ, Levin J. The clinical relevance of maintaining the functional integrity of the stratum corneum in both healthy and disease-affected skin. J Clin Aesthet Dermatol. 2011;4(9):22-42.
    9. Zivkovich AH, Feldman SR. Are ointments better than other vehicles for corticosteroid treatment of psoriasis. J Drugs Dermatol. 2009;8(6):570-572. 1,6,9
    10. Feldman SR, Yentzer BA. Topical clobetasol propionate in the treatment of psoriasis: a review of newer formulations. Am J Clin Dermatol. 2009;10(6):397-406.
    11. Huang W, Tanojo H, Lenn J, et al. A novel foam vehicle for delivery of topical corticosteroids. J Am Acad Dermatol. 2005;53:S26-S38.
    12. Kircik L, Lebwohl M, Del Rosso JQ, et al. Clinical study results of desoximetasone spray 0.25% in moderate to severe plaque psoriasis. J Drugs Dermatol. 2013;12(12):1404-1410.
    13. Del Rosso JQ, Kircik L. Not all corticosteroids are created equal! optimizing therapeutic outcomes through better understanding of vehicle formulations, compound selection, and methods of application. J Drugs Dermatol. 2013;11(12):S5-S8.
    14. Clobex Lotion [package insert], Galderma Laboratories, Fort Worth, TX, 2003.
    15. Kircik L, Okumu F, Kandavilli S, et al. Rational vehicle design ensures targeted cutaneous steroid delivery. J Clin Aesthet Dermatol. 2017;10(2):12-19.
    16. Sernivo Spray [package insert], Promius Pharma, Princeton, NJ, 2016.
    17. Vanos Cream [package insert], Valeant Pharmaceuticals, Bridgewater, NJ, 2017.
    18. Franz TJ, Lehman PA, Raney SG. Use of excised human skin to assess the bioequivalence of topical products. Skin Pharmacol Physiol. 2009;22(5):276- 286.
    19. Franz TJ, Parsell DA, Halualani RM, et al. Betamethasone valerate foam 0.12%: a novel vehicle with enhanced delivery and efficacy. Int J Dermatol. 1999;38(8):628-632.
    20. Olux Foam [package insert]. Mylan, Inc, Canonsburg, PA, 2014.
    21. Reid DC, Kimball AB. Clobetasol propionate foam in the treatment of psoriasis. Expert Opin Pharmacother. 2005;6(10):1735-1740.
    22. Olux-E Foam [package insert]. Mylan, Inc, Canonsburg, PA, 2014.
    23. Weiss S, Wyres M, Brundage T. A novel foam vehicle is consistently preferred by patients for dermatologic conditions [abstract]. J Am Acad Dermatol. 2011;64(2):AB50.
    24. Sorilux Foam [package insert]. Mayne Pharma, Greenville, NC, 2016.
    25. Fabior Foam [package insert]. Mayne Pharma, Greenville, NC, 2016.
    26. Jarrat M, Werner CP, Alio Saenz AB. Tazarotene foam vs tazarotene gel: a randomized relative bioavailability study in acne vulgaris. Clin Drug Investig. 2013;33(4):283-289.
    27. Feldman SR, Robert Matheson R, Bruce S, et al. Efficacy and safety of calcipotriene 0.005% foam for the treatment of plaque-type psoriasis: results of two multicenter, randomized, double-blind, vehicle-controlled, phase III clinical trials. Am J Clin Dermatol. 2012;13(4):261-271.
    28. Dovonex ointment [package insert], Leo Pharma Inc, Parsippany, NJ, 2007.
    29. Dovonex cream [package insert], Leo Pharma Inc, Parsippany, NJ, 2009.
    30. Dovonex scalp solution [package insert], Leo Pharma Inc, Parsippany, NJ, 2011.
    31. Del Rosso JQ. Azelaic acid topical formulations: differentiation of 15% gel and 15% foam. J Clin Aesthet Dermatol. 2017;10(3):37-40.
    32. Schreiber R, Lewis C, Crane K. Patient assessment of foam attributes from the tazarotene foam, 0.1%, phase III trials and potential impact on patient compliance. Poster presentation. Fall Clinical Dermatology, Las Vegas, Nevada, October 2018.
    33. Feldman SR, Werner CP, Alio Saenz AB. The efficacy and tolerability of tazarotene foam, 0.1%, in the treatment of acne vulgaris in 2 multicenter, vehicle-controlled, double-blind studies. J Drugs Dermatol. 2013;12(4):438-446.
    34. deShazo R, Krueger G Callis Duffin K. Topical agents. In: Koo JYM, Levin EC, Leon A, Wu JJ, Gottlieb AB, eds. Moderate to Severe Psoriasis. 4th ed. Boca Raton, FL: CRC Press Taylor & Francis Group. 2014:41-65.
    35. Hinds GA, Helfrich YR, Sachs DL, Kang S. Topical Vitamin D3, In: Wolverton SE, ed. Comprehensive Dermatologic Drug Therapy. 3rd ed. Philadelphia, PA. Saunders-Elsevier. 2013:543-549.
    36. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol. 2009;60(4):643-59
    37. Camarasa JM, Ortonne JP, Dubertret L. Calcitriol shows greater persistence of treatment effect than betamethasone dipropionate in topical psoriasis therapy. J Dermatolog Treat. 2003;14(1):8-13.
    38. Feldman SR, Eastman WJ, Brundage T, et al. A multicenter, randomized, double-blind study of the efficacy and safety of calcipotriene foam, 0.005%, vs vehicle foam for the treatment of plaque-type psoriasis of the scalp. J Drugs Dermatol. 2013;12(3):300-306.
    39. Sami N. Topical retinoids. In: Wolverton SE, ed. Comprehensive Dermatologic Drug Therapy. 3rd ed. Philadelphia, PA. Saunders-Elsevier. 2013:505-517.
    40. Del Rosso JQ, Tanghetti E. A status report on topical tazarotene in the management of acne vulgaris. J Drugs Dermatol. 2013;12(3):s53-58.
    41. Data on file. Mayne Pharma, Greenville, NC, 2018.
    42. Lebwohl M, Quijije J, Gilliard J, et al. Topical calcitriol is degraded by ultraviolet light. J Invest Dermatol. 2003;121(3):594-595.
    43. Patel B, Siskin S, Krazmien R, et al. Compatibility of calcipotriene with other topical medications. J Am Acad Dermatol. 1998;38(6 Pt 1):1010-1011

    AUTHOR CORRESPONDENCE

    James Q. Del Rosso DO jqdelrosso@yahoo.com
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