PMID- 25607706 OWN - NLM STAT- MEDLINE DCOM- 20150928 LR - 20150122 IS - 1545-9616 (Print) IS - 1545-9616 (Linking) VI - 13 IP - 11 DP - 2014 Nov TI - Long-term safety of ivermectin 1% cream vs azelaic acid 15% gel in treating inflammatory lesions of rosacea: results of two 40-week controlled, investigator-blinded trials. PG - 1380-6 AB - Papulopustular rosacea (PPR) is characterized by facial erythema and inflammatory lesions believed to be primarily caused by dysregulation of the innate immune system. More recent evidence also suggests that Demodex folliculorum mites may contribute to the etiology of PPR. Ivermectin (IVM) 1% cream is a novel topical treatment developed to treat PPR. Two phase 3 trials have demonstrated that IVM 1% cream was significantly better than vehicle at investigator global assessment (IGA) success rate and lesion reductions and that it was safe and well tolerated. Two 40-week extension studies of those trials were conducted to assess the long-term safety of IVM 1% cream vs azelaic acid (AzA) 15% gel. Subjects originally treated with IVM 1% continued on IVM 1% and those originally treated with vehicle switched to AzA 15% gel. IVM 1% cream was safe throughout the study with a lower incidence of related adverse events (AEs) compared to AzA 15% gel. No subjects in the IVM 1% cream group discontinued either study due to a related AE. IVM 1% also continued to be efficacious during the 40-week extension studies as the percentage of subjects with IGA scores of clear or almost clear was higher at the end of the study compared to baseline. The results of these 40-week extension studies support the use of IVM 1% cream as a long-term therapy for PPR as IVM 1% cream was shown to be safe and effective for up to 52 weeks of total treatment. FAU - Stein Gold, Linda AU - Stein Gold L FAU - Kircik, Leon AU - Kircik L FAU - Fowler, Joseph AU - Fowler J FAU - Jackson, J Mark AU - Jackson JM FAU - Tan, Jerry AU - Tan J FAU - Draelos, Zoe AU - Draelos Z FAU - Fleischer, Alan AU - Fleischer A FAU - Appell, Melanie AU - Appell M FAU - Steinhoff, Martin AU - Steinhoff M FAU - Lynde, Charles AU - Lynde C FAU - Sugarman, Jeffrey AU - Sugarman J FAU - Liu, Hong AU - Liu H FAU - Jacovella, Jean AU - Jacovella J CN - Ivermectin Phase 3 Study Group LA - eng PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - J Drugs Dermatol JT - Journal of drugs in dermatology : JDD JID - 101160020 RN - 0 (Dermatologic Agents) RN - 0 (Dicarboxylic Acids) RN - 0 (Gels) RN - 70288-86-7 (Ivermectin) RN - F2VW3D43YT (azelaic acid) SB - IM MH - Administration, Cutaneous MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Dermatologic Agents/administration & dosage/adverse effects/*therapeutic use MH - Dicarboxylic Acids/administration & dosage/adverse effects/*therapeutic use MH - Female MH - Gels MH - Humans MH - Ivermectin/administration & dosage/adverse effects/*therapeutic use MH - Male MH - Middle Aged MH - Rosacea/*drug therapy/pathology MH - Single-Blind Method MH - Skin Cream MH - Time Factors MH - Young Adult FIR - Baker, Diane IR - Baker D FIR - Oswego, Lake IR - Oswego L FIR - Elewski, Boni IR - Elewski B FIR - Nasir, Adnan IR - Nasir A FIR - Thomas, Richard IR - Thomas R FIR - Schlessinger, Joel IR - Schlessinger J FIR - Shuler, Marshall IR - Shuler M FIR - Meadows, Kappa P IR - Meadows KP FIR - Sheth, Pranav IR - Sheth P FIR - Jarratt, Michael IR - Jarratt M FIR - Langley, Richard IR - Langley R FIR - Nigen, Simon IR - Nigen S FIR - Carey, Wayne IR - Carey W FIR - Maloney, Michael J IR - Maloney MJ FIR - Toole, John W IR - Toole JW FIR - Wasel, Norman R IR - Wasel NR FIR - Sofen, Howard IR - Sofen H FIR - Landells, Ian IR - Landells I FIR - Tyring, Stephen K IR - Tyring SK FIR - Haber, Robert IR - Haber R FIR - Harris, Holly IR - Harris H FIR - Lee, Mark S IR - Lee MS FIR - Leonardi, Craig IR - Leonardi C FIR - Heffernan, Michael IR - Heffernan M FIR - Davidson, Lesly IR - Davidson L FIR - Gillum, Paul IR - Gillum P FIR - Swinyer, Leonard IR - Swinyer L FIR - Grekin, Steven IR - Grekin S FIR - Ling, Mark Russell IR - Ling MR FIR - Cather, Jennifer Clay IR - Cather JC FIR - Schiavone, Frank E IR - Schiavone FE FIR - Kantor, Jonathan IR - Kantor J FIR - Flores, Francisco IR - Flores F FIR - Hanke, C William IR - Hanke CW FIR - Mader, Russell D IR - Mader RD FIR - Berman, Brian IR - Berman B FIR - Pointon, Catherine J IR - Pointon CJ FIR - Gardner, Timothy IR - Gardner T FIR - Freiman, Anatoli IR - Freiman A FIR - Gooderham, Melinda IR - Gooderham M FIR - Afsahi, Vincent IR - Afsahi V FIR - Abson, Kim IR - Abson K FIR - Green, Lawrence J IR - Green LJ FIR - Hull, Cheryl IR - Hull C FIR - Nahm, Walter K IR - Nahm WK FIR - Rendon, Marta L IR - Rendon ML FIR - Guenthner, Scott IR - Guenthner S FIR - Jenkin, Peter IR - Jenkin P FIR - Lee, Jane IR - Lee J FIR - Sra, Karan IR - Sra K FIR - Stough, Dowling IR - Stough D FIR - Grande, Kimberly IR - Grande K FIR - Gratton, David IR - Gratton D FIR - Huang, Eugene IR - Huang E FIR - Martin, Ann G IR - Martin AG FIR - Miller, Stephen IR - Miller S FIR - Vender, Ronald IR - Vender R FIR - Harwell, William IR - Harwell W FIR - Poulin, Yves IR - Poulin Y FIR - Samady, Joseph IR - Samady J FIR - Shamban, Ava IR - Shamban A FIR - Guenther, Lyn IR - Guenther L FIR - Hamilton, Tiffani K IR - Hamilton TK FIR - Toth, Darryl IR - Toth D FIR - Hamzavi, Fasahat IR - Hamzavi F FIR - Gratiot, Fort IR - Gratiot F FIR - Kunynetz, Rodion A IR - Kunynetz RA FIR - Moore, Angela IR - Moore A FIR - Moore, Jeffrey IR - Moore J FIR - Rosoph, Les IR - Rosoph L FIR - Tschen, Eduardo IR - Tschen E FIR - Dawes, Kenneth IR - Dawes K FIR - Wiltz, Hector IR - Wiltz H FIR - Bagel, Jerry IR - Bagel J FIR - Rafal, Elyse IR - Rafal E FIR - Murakawa, George IR - Murakawa G FIR - Albrecht, Lorne IR - Albrecht L FIR - Thiboutot, Diane IR - Thiboutot D FIR - Schlosser, Bethanee IR - Schlosser B FIR - Greenstein, David IR - Greenstein D FIR - Rich, Phoebe IR - Rich P FIR - Solomon, James IR - Solomon J FIR - Pollack, Andrew IR - Pollack A FIR - Fivenson, David IR - Fivenson D FIR - Parish, Lawrence IR - Parish L FIR - Bodie, Fred IR - Bodie F FIR - Sugarman, Jeffrey IR - Sugarman J FIR - Gottlieb, Scott IR - Gottlieb S FIR - Davis, Steven IR - Davis S FIR - Raman, Mani IR - Raman M FIR - Chen, Suephy IR - Chen S FIR - Fried, Richard IR - Fried R FIR - Nguyen, Ethan IR - Nguyen E FIR - Oyler, Rebekah IR - Oyler R FIR - Bukhalo, Michael IR - Bukhalo M EDAT- 2015/01/22 06:00 MHDA- 2015/09/29 06:00 CRDT- 2015/01/22 06:00 PHST- 2015/01/22 06:00 [entrez] PHST- 2015/01/22 06:00 [pubmed] PHST- 2015/09/29 06:00 [medline] AID - S1545961614P1380X [pii] PST - ppublish SO - J Drugs Dermatol. 2014 Nov;13(11):1380-6.