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Original Research A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Ammonium Lactate Lotion 12% and Halobetasol Propionate Ointment 0.05% in the Treatment and Maintenance of Psoriasis
February 2011
Jason J. Emer, MD; Amylynne Frankel, MD; Andrew Sohn, BS; Mark Lebwohl, MDMount Sinai School of Medicine, Department of Dermatology, New York, New York

Disclosure:Dr. Emer, Dr. Frankel, and Mr. Sohn report no relevant conflicts of interest. Dr. Lebwohl lectures for Ranbaxy. Funding sources for this study were provided by Ranbaxy Laboratories, Inc. The data for this clinical trial have been presented in poster format at the Winter Clinical Dermatology Conference, Grand Hyatt Kauai, Hawaii; January 2328, 2010, and the Fall Clinical Dermatology Conference, Wynn Hotel, Las Vegas, Nevada; October 1619, 2010.

Abstract

Consensus recommends a gradual reduction in the frequency or steroid potency of topical corticosteroids following clinical improvement in the treatment of psoriasis, although no established guidelines have been developed. The authors sought to evaluate a combination regimen in the treatment and maintenance of psoriasis. Patients with mild-to-moderate psoriasis were enrolled (n=55) in a randomized, double-blind, placebo-controlled study using ammonium lactate lotion and halobetasol ointment. Those with initial improvement of target plaques after two weeks of combination treatment twice daily were randomized to a maintenance phase (n=41). Patients applied ammonium lactate lotion twice daily every day and either placebo ointment (n=20) or steroid ointment (n=21) twice daily on weekends only. Forty-one of 55 patients(74.6%) were rated as clear(0) or almost clear (1) after two weeks of combination treatment. In the maintenance phase, the probability of physician global assessment worsening at six weeks in the steroid group was only 10 percent while in the placebo group the probability rose to 75 percent (p<0.0001). The probability of physician global assessment worsening climbed to 100 percent by 14 weeks in the placebo group while only increasing to 29 percent in the steroid group (p<0.0001).Twelve patients at study termination still had not worsened. Worsening of the physician global assessment index was more likely (HR 7.8 [2.84, 21.43]) in the placebo group than in the steroid group (p<0.0001). No cutaneous side effects, such as steroid atrophy or irritation, were noted. Combination treatment effectively cleared plaque psoriasis initially, and ammonium lactate twice daily every day with weekend-only applications of halobetasol ointment effectively sustained the initial improvement for a significantly longer period of time when compared with placebo without demonstrating any significant side effects, such as steroid atrophy. (J Clin Aesthet Dermatol . 2011;4(2):2839.)

Conclusion

Combination twice-daily ammonium lactate lotion and halobetasol ointment for two weeks effectively cleared plaque psoriasis in approximately 75 percent of patients. Halobetasol ointment weekend-only maintenance therapy in combination with twice-daily ammonium lactate lotion effectively sustained initial improvement for a significantly longer period of time when compared with placebo. No adverse effects, such as cutaneous irritation, atrophy, or telangiectasia, were noted through the study. Although topical corticosteroids are an integral part of the therapeutic treatment options for the treatment of psoriasis and extremely safe when used judiciously in the short term, long-term maintenance regimens incorporating dose or frequency reduction or the addition of a second corticosteroid-sparing agent is the most optimal for successful remissions. Future studies incorporating combination or

rotational therapies in the long term will determine guidelines for most advantageous remissions and maintenance thereof.

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