Researcher experiments with reformulating psoriasis topical as a lotion instead of cream, which performed well with patients.
The corticosteroid halobetasol performed better as a lotion than its cream counterpart in a phase two study that examined both the type topical and its concentration. The lotion was administered in a lesser concentration with similar efficacy.
“The number one reason why topical agents do not work is because of lack of adherence to a given agent,” said co-investigator Francisco Kerdel, M.D., of the Florida Academic Dermatology Centers in Miami. “This applies to creams, lotions and ointments. But by actually formulating an old effective molecule in lotion form, as opposed to cream form, in a more easy to use and elegant vehicle, patient compliance is increased and outcomes will improve.”
Dr. Kerdel conducted a multi-center study of 150 patients who were randomized to one of three treatment groups: halobetasol 0.01 percent lotion, halobetasol 0.05 percent cream, or vehicle minus the active ingredient. Patients applied the product once daily for two weeks.
“The study showed that the weaker strength of halobetasol achieved the same results as the stronger strength,” said Dr. Kerdel, who presented study outcomes at the 2018 Fall Clinical Dermatology Conference.
The lotion and cream were statistically equivalent at two weeks for all efficacy evaluations. Overall, 30.0 percent and 31.6 percent of patients were considered treatment successes, respectively.
Specifically, at two weeks, for the lower-concentration lotion there was a two grade improvement from baseline in the Investigator Global Assessment (IGA) for erythema (38.3 percent of patients), plaque elevation (40.0 percent) and scaling (43.3 percent).
The higher-concentration cream also attained a 2-grade improvement from baseline in IGA for erythema (31.6 percent of patients), plaque elevation (36.8 percent) and scaling (47.4 percent).
Furthermore, the lotion improved body surface area (BSA) by 22.3 percent compared to 20.0 percent for the cream.
“I am surprised by the results,” Dr. Kerdel said. “Most of the time when we think traditionally about vehicles that have active ingredients added, we believe that by being more occlusive that the product will be more effective. Generally, a cream is thicker than a lotion, so we would be mistaken to think that the cream would actually work better, when it fact it proved to be the opposite.”
The tolerability of the lotion and cream was the same. But there were two treatment-related application site reactions, one each for lotion and vehicle. Both were mild to moderate reactions that resolved quickly.
There were also no reports of skin atrophy, striae, telangiectasia or folliculitis in any of the three treatment groups.
Once the lotion becomes commercially available, Dr. Kerdel expects that the dermatologic community will embrace it. “We find that things that are easier and less messy to apply are used more frequently and therefore patients achieve a greater amount of success,” he said. “Patients are happier and continue using the treatment.”
Dr. Kerdel also believes topical adverse events with the lotion might have been fewer and milder than for the cream, if the study had extended over a longer period, due to the fact that the cream had a stronger concentration.
The lotion will likely be applied once a day, after the patient bathes and the skin is moist.
Dr. Kerdel conducts clinical studies for Ortho Dermatologics.