SEOUL, SOUTH KOREA – The combination of calcipotriene and nicotinamide may be an attractive corticosteroid-sparing option for topical psoriasis therapy, according to results from a pilot trial.
"Both agents are somewhat effective for psoriasis; the combination of the two is markedly superior," Dr. Mark Lebwohl said in summarizing the findings of a pilot bilateral comparative study presented at the World Congress of Dermatology.
Dr.Mark Lebwohl
The investigational topical combination therapy is being developed by Dermipsor, an Israeli pharmaceutical company.
Dr. Lebwohl was a coinvestigator in the multicenter, double-blind, 12-week pilot study involving 168 patients with symmetric moderate psoriasis (defined as not more than 15% body surface area involvement).
The patients were randomized to two of seven treatments: calcipotriene 0.005% monotherapy, nicotinamide 1.4% alone, placebo, or calcipotriene 0.005% plus nicotinamide in a concentration of either 0.05%, 0.1%, 0.7%, or 1.4%. Patients treated the lesions on one side of the body with one of their two assigned treatments, and lesions on the opposite side with the other.
The primary end point was efficacy (defined as a clear to almost-clear outcome at week 12), which was achieved in 19% of patients who were treated with placebo, 25% of those on nicotinamide 1.4% alone, 31.5% of those treated with calcipotriene alone, and 50% of patients in the calcipotriene plus nicotinamide 1.4% group, reported Dr. Lebwohl, professor and chairman of the department of dermatology at Mount Sinai School of Medicine, New York.
The 50% clear or almost-clear rate with calcipotriene plus nicotinamide 1.4% is similar to the 48% rate of absent to very mild disease that was previously reported with a calcipotriol/betamethasone combination in a 52-week study (Dermatology 2006;213:319-26).
Thus, the calcipotriene/nicotinamide combination is an agent that will be investigated further in larger, lengthier studies as a possible steroid-sparing agent in comparative trials vs. calcipotriene-steroid combination therapy, Dr. Lebwohl said.
Topical combination therapy continues to be an active area in psoriasis research, he observed.
"It’s really a no-brainer: The combination of two ingredients is going to be superior to either one alone. It’s a very simple concept: Two is better than one," he said.
Dr. Lebwohl disclosed that he is a consultant to Dermipsor and has advisory board relationships with other pharmaceutical companies that are developing dermatologic drugs.