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A novel topical minocycline foam for the treatment of moderate-to-severe acne vulgaris: Results of 2 randomized, double-blind, phase 3 studies

Published:August 27, 2018DOI:https://doi.org/10.1016/j.jaad.2018.08.020

      Background

      FMX101 4% is a topical minocycline foam for the treatment of moderate-to-severe acne.

      Objective

      Evaluate the efficacy and safety of FMX101 4% in treating moderate-to-severe acne vulgaris.

      Methods

      Two identical phase 3 studies were conducted. Subjects were randomized 2:1 to once-daily FMX101 4% or foam vehicle for 12 weeks. The coprimary end points were the change in inflammatory lesion count from baseline and the rate of treatment success according to the Investigator's Global Assessment (a score of 0 or 1 for clear or almost clear, with a ≥2-grade improvement) at week 12.

      Results

      A total of 961 subjects were enrolled (study 04, N = 466; study 05, N = 495). Compared with vehicle, FMX101 4% demonstrated a significantly greater reduction in inflammatory lesions in both studies (P < .05) and a greater rate of treatment success in study 05 according to the Investigator's Global Assessment (P < .05). Pooled analyses of the 2 studies demonstrated statistical significance for both coprimary end points (all P < .05). Noninflammatory lesion count was also significantly reduced with FMX101 4% versus with vehicle in both studies. FMX101 4% was generally safe and well tolerated. Skin-related adverse events were reported in less than 1% of subjects treated with FMX101 4%.

      Limitations

      Longer-term efficacy and safety outcomes are needed (ongoing).

      Conclusion

      FMX101 4% topical minocycline foam significantly reduced both inflammatory and noninflammatory lesions and improved Investigator's Global Assessment scores in patients with moderate-to-severe acne.

      Key words

      Abbreviations used:

      AV (acne vulgaris), CI (confidence interval), IGA (Investigator's Global Assessment), LSM (least-square mean), RR (risk ratio), TEAE (treatment-emergent adverse event)
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      References

        • Zaenglein A.L.
        • Pathy A.L.
        • Schlosser B.J.
        • et al.
        Guidelines of care for the management of acne vulgaris.
        J Am Acad Dermatol. 2016; 74: 945-973.e33
        • Gieler U.
        • Gieler T.
        • Kupfer J.P.
        Acne and quality of life - impact and management.
        J Eur Acad Dermatol Venereol. 2015; 29: 12-14
        • Ochsendorf F.
        Minocycline in acne vulgaris: benefits and risks.
        Am J Clin Dermatol. 2010; 11: 327-341
        • Garner S.E.
        • Eady A.
        • Bennett C.
        • Newton J.N.
        • Thomas K.
        • Popescu C.M.
        Minocycline for acne vulgaris: efficacy and safety.
        Cochrane Database Syst Rev. 2012; 15: CD002086
        • Adler B.L.
        • Kornmehl H.
        • Armstrong A.W.
        Antibiotic resistance in acne treatment.
        JAMA Dermatol. 2017; 153: 810-811
        • Walsh T.R.
        • Efthimiou J.
        • Dreno B.
        Systematic review of antibiotic resistance in acne: an increasing topical and oral threat.
        Lancet Infect Dis. 2016; 16: e23-e33
        • Mendoza N.
        • Hernandez P.O.
        • Tyring S.K.
        • Haitz K.A.
        • Motta A.
        Antimicrobial susceptibility of Propionibacterium acnes isolates from acne patients in Colombia.
        Int J Dermatol. 2013; 52: 688-692
        • Biswal I.
        • Gaind R.
        • Kumar N.
        • et al.
        In vitro antimicrobial susceptibility patterns of Propionibacterium acnes isolated from patients with acne vulgaris.
        J Infect Dev Ctries. 2016; 10: 1140-1145
        • Jones T.M.
        • Ellman H.
        • deVries T.
        Pharmacokinetic comparison of once-daily topical minocycline foam 4% vs oral minocycline for moderate-to-severe acne.
        J Drugs Dermatol. 2017; 16: 1022-1028
        • Shemer A.
        • Shiri J.
        • Mashiah J.
        • Farhi R.
        • Gupta A.K.
        Topical minocycline foam for moderate to severe acne vulgaris: phase 2 randomized double-blind, vehicle-controlled study results.
        J Am Acad Dermatol. 2016; 74: 1251-1252
      1. Solodyn [package insert]. Valeant Pharmaceuticals North America LLC, Bridgewater, NJJune 2016
        • Anderson K.L.
        • Dothard E.H.
        • Huang K.E.
        • Feldman S.R.
        Frequency of primary nonadherence to acne treatment.
        JAMA Dermatol. 2015; 151: 623-626
        • Dreno B.
        • Thiboutot D.
        • Gollnick H.
        • et al.
        Large-scale worldwide observational study of adherence with acne therapy.
        Int J Dermatol. 2010; 49: 448-456
        • Snyder S.
        • Crandell I.
        • Davis S.A.
        • Feldman S.R.
        Medical adherence to acne therapy: a systematic review.
        Am J Clin Dermatol. 2014; 15: 87-94
        • Housman T.S.
        • Mellen B.G.
        • Rapp S.R.
        • Fleischer Jr., A.B.
        • Feldman S.R.
        Patients with psoriasis prefer solution and foam vehicles: a quantitative assessment of vehicle preference.
        Cutis. 2002; 70: 327-332
        • Tamarkin D.
        • Friedman D.
        • Shemer A.
        Emollient foam in topical drug delivery.
        Expert Opin Drug Deliv. 2006; 3: 799-807
        • Russell J.J.
        Topical therapy for acne.
        Am Fam Physician. 2000; 61: 357-366
        • Simonart T.
        • Dramaix M.
        Treatment of acne with topical antibiotics: lessons from clinical studies.
        Br J Dermatol. 2005; 153: 395-403