PMID- 30588269 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20201001 IS - 1941-2789 (Print) IS - 1941-2789 (Linking) VI - 11 IP - 11 DP - 2018 Nov TI - Safety and Efficacy of a Halobetasol 0.01%/Tazarotene 0.045% Fixed Combination Lotion in the Treatment of Moderate-to-severe Plaque Psoriasis: A Comparison with Halobetasol Propionate 0.05% Cream. PG - 15-19 AB - Background: Topical corticosteroids (TCS) represent a mainstay of psoriasis treatment, though more potent formulations are not recommended for use for more than 2 to 4 weeks. Objective: We sought to investigate the safety and efficacy of once-daily halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion and halobetasol propionate 0.05% cream in patients with moderate-to-severe plaque psoriasis. Methods: This was a multicenter, randomized, double-blind, parallel-group, vehicle-controlled Phase II study (n=154). Patients were randomized (2:2:1) to HP 0.01%/TAZ 0.045% lotion, halobetasol propionate 0.05% cream, or vehicle, applied topically once daily for two weeks. Efficacy assessments included treatment success, impact on individual psoriasis signs (i.e., erythema, plaque elevation, and scaling) at target lesion, and body surface area (BSA). Safety and adverse events (AEs) were evaluated throughout. Results: HP/TAZ lotion was significantly more effective than vehicle and was comparable to halobetasol propionate 0.05% cream in reducing erythema, plaque elevation, and scaling. Of the HP/TAZ patients, 32.8 percent achieved treatment success versus 34.0 and 3.3 percent in the halobetasol and vehicle groups. At Week 2, treatment success was seen in 34.4 percent (erythema), 54.1 percent (plaque elevation), and 60.7 percent (scaling) of patients versus in 43.5, 50.8, and 50.8 percent receiving halobetasol. A 25.0- and 24.8-percent reduction in BSA occurred, respectively. The most frequently reported, treatment-related AE was application site pain. Conclusions: The efficacy of HP/TAZ lotion was comparable to a higher concentration of 0.05% halobetasol cream, showing rapid treatment success after two weeks with good safety. FAU - Bhatia, Neal D AU - Bhatia ND AD - Dr. Bhatia is with Therapeutics Clinical Research in San Diego, California. AD - Dr. Pariser is with Virginia Clinical Research, Inc. in Norfolk, Vriginia. AD - Dr. Kircik is with the Indiana University School of Medicine in Indianapolis, Indiana; Physicians Skin Care, PLLC in Louisville, Kentucky, and the Icahn School of Medicine at Mount Sinai in New York, New York. AD - Dr. Lin is with Ortho Dermatologics in Bridgewater, New Jersey. Mses. Harris and Mathew are with Bausch Health in Bridgewater, New Jersey. AD - Dr. Pillai is with Dow Pharmaceutical Sciences Inc. in Petaluma, California. FAU - Pariser, David M AU - Pariser DM AD - Dr. Bhatia is with Therapeutics Clinical Research in San Diego, California. AD - Dr. Pariser is with Virginia Clinical Research, Inc. in Norfolk, Vriginia. AD - Dr. Kircik is with the Indiana University School of Medicine in Indianapolis, Indiana; Physicians Skin Care, PLLC in Louisville, Kentucky, and the Icahn School of Medicine at Mount Sinai in New York, New York. AD - Dr. Lin is with Ortho Dermatologics in Bridgewater, New Jersey. Mses. Harris and Mathew are with Bausch Health in Bridgewater, New Jersey. AD - Dr. Pillai is with Dow Pharmaceutical Sciences Inc. in Petaluma, California. FAU - Kircik, Leon AU - Kircik L AD - Dr. Bhatia is with Therapeutics Clinical Research in San Diego, California. AD - Dr. Pariser is with Virginia Clinical Research, Inc. in Norfolk, Vriginia. AD - Dr. Kircik is with the Indiana University School of Medicine in Indianapolis, Indiana; Physicians Skin Care, PLLC in Louisville, Kentucky, and the Icahn School of Medicine at Mount Sinai in New York, New York. AD - Dr. Lin is with Ortho Dermatologics in Bridgewater, New Jersey. Mses. Harris and Mathew are with Bausch Health in Bridgewater, New Jersey. AD - Dr. Pillai is with Dow Pharmaceutical Sciences Inc. in Petaluma, California. FAU - Lin, Tina AU - Lin T AD - Dr. Bhatia is with Therapeutics Clinical Research in San Diego, California. AD - Dr. Pariser is with Virginia Clinical Research, Inc. in Norfolk, Vriginia. AD - Dr. Kircik is with the Indiana University School of Medicine in Indianapolis, Indiana; Physicians Skin Care, PLLC in Louisville, Kentucky, and the Icahn School of Medicine at Mount Sinai in New York, New York. AD - Dr. Lin is with Ortho Dermatologics in Bridgewater, New Jersey. Mses. Harris and Mathew are with Bausch Health in Bridgewater, New Jersey. AD - Dr. Pillai is with Dow Pharmaceutical Sciences Inc. in Petaluma, California. FAU - Harris, Susan AU - Harris S AD - Dr. Bhatia is with Therapeutics Clinical Research in San Diego, California. AD - Dr. Pariser is with Virginia Clinical Research, Inc. in Norfolk, Vriginia. AD - Dr. Kircik is with the Indiana University School of Medicine in Indianapolis, Indiana; Physicians Skin Care, PLLC in Louisville, Kentucky, and the Icahn School of Medicine at Mount Sinai in New York, New York. AD - Dr. Lin is with Ortho Dermatologics in Bridgewater, New Jersey. Mses. Harris and Mathew are with Bausch Health in Bridgewater, New Jersey. AD - Dr. Pillai is with Dow Pharmaceutical Sciences Inc. in Petaluma, California. FAU - Mathew, Lindsey AU - Mathew L AD - Dr. Bhatia is with Therapeutics Clinical Research in San Diego, California. AD - Dr. Pariser is with Virginia Clinical Research, Inc. in Norfolk, Vriginia. AD - Dr. Kircik is with the Indiana University School of Medicine in Indianapolis, Indiana; Physicians Skin Care, PLLC in Louisville, Kentucky, and the Icahn School of Medicine at Mount Sinai in New York, New York. AD - Dr. Lin is with Ortho Dermatologics in Bridgewater, New Jersey. Mses. Harris and Mathew are with Bausch Health in Bridgewater, New Jersey. AD - Dr. Pillai is with Dow Pharmaceutical Sciences Inc. in Petaluma, California. FAU - Pillai, Radhakrishnan AU - Pillai R AD - Dr. Bhatia is with Therapeutics Clinical Research in San Diego, California. AD - Dr. Pariser is with Virginia Clinical Research, Inc. in Norfolk, Vriginia. AD - Dr. Kircik is with the Indiana University School of Medicine in Indianapolis, Indiana; Physicians Skin Care, PLLC in Louisville, Kentucky, and the Icahn School of Medicine at Mount Sinai in New York, New York. AD - Dr. Lin is with Ortho Dermatologics in Bridgewater, New Jersey. Mses. Harris and Mathew are with Bausch Health in Bridgewater, New Jersey. AD - Dr. Pillai is with Dow Pharmaceutical Sciences Inc. in Petaluma, California. LA - eng PT - Journal Article DEP - 20181101 PL - United States TA - J Clin Aesthet Dermatol JT - The Journal of clinical and aesthetic dermatology JID - 101518173 PMC - PMC6303116 OTO - NOTNLM OT - Psoriasis OT - clinical trial OT - halobetasol OT - tazarotene OT - topical COIS- FUNDING:Ortho Dermatologics funded the activities of Konic Ltd. (West Sussex, England, United Kingdom) pertaining to this manuscript. Konic Lts. provided editorial services. DISCLOSURES:Dr. Bhatia is an advisor, consultant, investigator, and speaker with Ortho Dermatologics. Dr. Pariser is an adviser and investigator with Ortho Dermatologics. Dr. Kircik is an adviser, consultant and investigator with Ortho Dermatologics. Drs. Lin and Pillai and Mses. Harris and Mathew are employees of Bausch Health. EDAT- 2018/12/28 06:00 MHDA- 2018/12/28 06:01 PMCR- 2018/11/01 CRDT- 2018/12/28 06:00 PHST- 2018/12/28 06:00 [entrez] PHST- 2018/12/28 06:00 [pubmed] PHST- 2018/12/28 06:01 [medline] PHST- 2018/11/01 00:00 [pmc-release] PST - ppublish SO - J Clin Aesthet Dermatol. 2018 Nov;11(11):15-19. Epub 2018 Nov 1.