Update on the Management of Rosacea: A Status Report on the Current Role and New Horizons With Topical Azelaic Acid

December 2014 | Volume 13 | Issue 12 | Supplement Individual Articles | 101 | Copyright © December 2014


James Q. Del Rosso DO FAOCDa and Leon H. Kircik MDb

aLas Vegas Skin and Cancer Clinics/West Dermatology Group, Henderson, NV; Touro University College of Osteopathic Medicine, Henderson, NV
bIcahn School of Medicine at Mount Sinai, New York, NY; Indiana University School of Medicine, Indianapolis, IN;
Physicians Skin Care, PLLC, Louisville, KY

New Horizons With Azelaic Acid 15%

An oil-in-water emulsion foam formulation of micronized AzA 15% is under development and has been evaluated through the stage of Phase 3 clinical studies.51 A randomized, doubleblind, vehicle-controlled, multicenter, parallel-group study was conducted over 12 weeks with a 4-week follow-up period, evaluating the efficacy and safety of AzA 15% foam (n=198) applied twice daily compared with a vehicle foam (n=203) applied twice daily in adult subjects with moderate PPR (approximately 90% of subjects) or severe PPR (approximately 10% of subjects).51 Primary efficacy variables assessed were IGA dichotomized into success and failure, and nominal change in inflammatory lesion count from baseline to end of treatment. The mean inflammatory lesion count at baseline was 21.6 in the AzA 15% foam group and 20.4 in the vehicle foam group.
  • At week 12 (end of treatment), 43.4% of AzA 15% foam-treated subjects achieved treatment success (IGA score of clear or minimal) compared with 32.5% in the vehicle arm (P=.17).
  • At week 12, the mean nominal inflammatory lesion reduction and mean percent reduction in inflammatory lesions were -13.4 and 65.4% respectively in the AzA 15% foam group, and -9.5 and 51% respectively in the vehicle foam group (P<.001, both parameters).
  • Skin tolerability was favorable in both study groups. Application site burning sensation, stinging, and pruritus were reported as 1.5%, 2.5%, and 1.5% respectively in the AzA 15% foam study group, and as 0% for all 3 parameters in the vehicle foam study group. Importantly, this low number of subjects experiencing stinging and/or burning occurred despite the protocol not mandating use of designated gentle skin care products.51
    • Study outcomes show that the new foam formulation of AzA 15% is effective and well-tolerated in patients with moderate to severe PPR. Although no single formulation is appropriate for all patients, the availability of multiple vehicles assists the clinician in matching the needs and preferences of individual patients, especially given the favorable tolerability reported in the Phase 3 data with AzA 15% foam.51

    CONCLUDING REMARKS

    Azelaic acid 15% gel boasts a long track record of both efficacy and safety for the treatment of PPR. The optimal use of AzA 15% gel is with concurrent proper skin care, either as monotherapy in patients with mild to moderate PPR, or in combination with oral therapy (ie, doxycycline) in patients with moderate to severe PPR. Once adequate control of PPR is achieved, AzA 15% gel can be continued without the oral agent to sustain the reduction in papulopustular lesions and associated inflammatory erythema.
    There is some suggestive evidence that when used in combination with doxy-MR 40 mg QD, AzA 15% gel may provide a slightly quicker onset and greater magnitude of improvement of PPR overall than metro 1%. Although the differences are incremental based on study data, it may be clinically relevant in some patients who are anxious to see improvement, especially due to the chronicity of their disease.
    There are new data supporting the anti-inflammatory activity of AzA through reduction of the cathelicidin pathway that is upregulated in rosacea-affected skin. If patients are not fully compliant and are using AzA 15% gel once daily instead of twice daily, there is comfort in knowing that once-daily application proved to be comparable to twice-daily application in patients with PPR. Lastly, the development of AzA 15% foam offers another vehicle option, and provides efficacy, safety, and a low incidence of skin tolerability reactions based on pivotal trial outcomes.

    DISCLOSURES

    This publication was supported by Bayer Healthcare. No one at Bayer Healthcare or any affiliated agency influenced the content of this publication. Only the authors participated in content and publication interactions.
    Dr. Del Rosso has served as a consultant, advisory board participant, clinical investigator, and/or speaker for Allergan, Anacor, Aqua, Bayer Healthcare (Dermatology), Celgene, Dermira, Ferndale, Galderma, Innocutis, LeoPharma, Merz Pharmaceuticals, Pharmaderm, Promius, PuraCap, Ranbaxy, Sebacia, Taro Pharmaceuticals, Unilever, and Valeant Pharmaceuticials.
    Dr. Kircik has served as an advisor, investigator, consultant, and speaker for Allergan, Bayer, Galderma, Promius Pharma, Quinnova, Stiefel/GSK, LeoPharma, Taro, Valeant, and Warner-Chilcott.

    REFERENCES

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    4. Fleischer AB Jr. Inflammation in rosacea and acne: Implications for patient care. J Drugs Dermatol. 2011;10(6):614-620.
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