A fixed combination lotion of halobetasol and tazarotene (HP/TAZ) provides rapid relief from psoriasis symptoms with a predictable safety profile and with superior benefits over both TAZ and HP alone by week 2 of treatment, according to a study published in the Journal of Drugs in Dermatology.
For this randomized, double-blind, vehicle-controlled, multicenter, phase 2 clinical trial, researchers randomly assigned 212 participants with moderate to severe psoriasis into 4 treatment groups: 0.01% halobetasol/0.045% tazarotene lotion (HP/TAZ), HP only, TAZ only, or vehicle. Patients received treatments once daily for 8 weeks and treatment success was defined as at least 2 grades of improvement in the Investigator Global Assessment (IGA) score from baseline with a score of “almost clear” or “clear.” At baseline, 92.9% of participants (n=197) had a moderate IGA score of 3 and 7.1% (n=15) had a severe IGA score of 4. Other efficacy assessments included the impact on psoriasis symptoms at the target lesion (plaque elevation, scaling, and erythema).
By 2 weeks of treatment, the HP/TAZ group showed statistically significant superior treatment success over vehicle (P =.047) and TAZ (P =.029), with 47.5% of patients showing “clear,” “almost clear,” or “mild,” compared with 33.3% of the HP group, 16.9% of the TAZ group, and 12.9% of the vehicle group. Scaling and plaque elevation were significantly improved in the HP/TAZ group vs HP, TAZ, or vehicle group, while erythema was only significantly improved compared with TAZ. Improvements in baseline itching, dryness, and burning/stinging found with HP/TAZ (45.6%, 42.2%, and 55.9%, respectively) were similar to HP, but greater than seen with TAZ (30.8%, P =.099; 35.4%, and 13.3%). In the first 2 weeks of treatment, none of the treatment groups reported striae, skin atrophy, folliculitis, or telangiectasias.
Study investigators concluded that HP/TAZ lotion is both effective and well-tolerated and can provide rapid results within 2 weeks. “The benefits in disease severity, reduction in plaque elevation and scaling, appear to be synergistic to its two active ingredients when used as monotherapy” and “the irritant effects and increase in BSA seen with tazarotene therapy were not apparent with the fixed combination.”
Disclosure: Ortho Dermatologics, a division of Bausch Health, funded manuscript preparation assistance by Brian Bulley, MSc (Konic Limited, UK).
Stein Gold L, Kircik LH, Pariser D, et al. Rapid onset of action in patients with moderate-to-severe plaque psoriasis with halobetasol 0.01%/tazarotene 0.045% fixed combination. J Drugs Dermatol. 2018;17(8):863-868.