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Journal of Immunotoxicology Volume 16, 2019 - Issue 1
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Research Articles

Topical minocycline foam 4%: Results of four phase 1 studies evaluating the potential for phototoxicity, photoallergy, sensitization, and cumulative irritation

Jonathan DosikTKL Research, Inc., Fair Lawn, NJ, USA; View further author information
,
Herman EllmanFormerly Foamix Pharmaceuticals, Inc. (Ret.), Bridgewater, NJ, USA; View further author information
&
Iain StuartFoamix Pharmaceuticals, Inc., Bridgewater, NJ, USACorrespondence[email protected]
View further author information
Pages 133-139 | Received 15 Mar 2019, Accepted 17 Apr 2019, Published online: 08 Jun 2019

References

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  • Gold L, Dhawan S, Weiss J, Draelos Z, Ellman H. 2018. FMX101 4% minocycline foam for the treatment of acne vulgaris: Safety and patient satisfaction from the open-label extension of two Phase 3 studies. Presented at: Winter Clinical Dermatology Conference; January 12–17; Maui, HI.
  • Gold L, Dhawan S, Weiss J, Draelos Z, Ellman H, Stuart I. 2019. A novel topical minocycline foam for the treatment of moderate-to-severe acne vulgaris: Results of 2 randomized, double-blind, Phase 3 studies. J Am Acad Dermatol. 80:168–177.
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  • Raoof J, Hooper D, Moore A, Zaiac M, Sullivan T, Kircik L, Lain E, Jankicevik J, Stuart I. 2018. FMX101 4% topical minocycline foam for the treatment of moderate-to-severe acne vulgaris: Efficacy and safety from a Phase 3 randomized, double-blind, vehicle-controlled study. Presented at: Fall Clinical Dermatology Conference; October 18–21; Las Vegas, NV.
  • Solodyn® [package insert]. 2016. Bridgewater (NJ): Valeant Pharmaceuticals North America LLC; [accessed 2019 Apr 11]. http://www.solodyn.com.
  • Tamarkin D, Friedman D, Shemer A. 2006. Emollient foam in topical drug delivery. Expert Opin Drug Deliv. 3:799–807.
  • U.S. Food and Drug Administration (UD FDA). 2018. Guidance, compliance, and regulatory information. Updated 2018 Dec 11. https://www.fda.gov/Drugs/GuidanceCompliance Regulatory Information/default.htm. Accessed 2019 Apr 11.
  • Zaenglein A, Pathy A, Schlosser B, Alikhan A, Baldwin H, Berson D, Bowe W, Graber E, Harper J, Kang S, et al. 2016. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 74:945–973.

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