Corticosteroid Emulsion Effective in Clearing Atopic Dermatoses

A corticosteroid emulsion containing 0.05% fluticasone propionate effectively clears inflammatory atopic dermatosis in a wide range of patients.

"Fluticasone propionate emulsion is a valuable addition to the range of therapies available for the treatment of corticosteroid-responsive dermatoses in adults and children over 3 months of age," said Lawrence Eichenfield, MD, Specialty Care Physician, Children's Hospital and Health Center, and University of California, San Diego, United States.

In a poster presentation at the 63rd Annual Meeting of the American Academy of Dermatology, Dr. Eichenfield reviewed results from two major clinical trials in which fluticasone propionate emulsion was compared with placebo vehicles.

For the primary endpoint - overall treatment success, defined as at least a 50% clearance of lesions plus improvement/no change in 75% of the 20-symptom assessment - 83 of 110 patients in one study achieved that goal compared to 31 of 110 patients in the placebo arm. That difference reached statistical significance at the P <.001 level.

In a second study, the same primary endpoint was achieved by 73 of 111 patients compared with 28 of 107 placebo patients. Again, Dr. Eichenfield said the difference was statistically significant at the P <.001 level.

The active emulsion was also found to be statistically better than placebo in clearing lesions by 50% and causing improvement or no change in the 20-symptom assessment. It was also significantly better than placebo according to the Investigator Global Assessment, and the patient's own assessment of response to therapy.

"Inflammatory dermatoses can affect all areas of the body including the scalp, other hirsute or intertriginous areas," Dr. Eichenfield noted in his presentation. "In these difficult-to-treat areas, an emulsion formulation may be more cosmetically acceptable to patients than ointments or creams."

The two studies were identical in design and enrolled a total of 438 subjects with moderate to severe atopic dermatitis. The study participants applied the emulsion or a placebo vehicle on all affected areas of the body for 4 weeks - excluding eyelids, peri-oral area, nostrils and diaper area in infants. The patients were generally evenly split by sex; about half were under age 16 and the others were adults up to age 87.

The emulsion was well tolerated; 5 patients who received the active ingredient and 8 placebo patients withdrew from the study. Adverse events that were possibly drug related were similar for patients treated with the active ingredient and those receiving the placebo vehicle.

The study was sponsored by GlaxoSmithKline.

[Presentation title: Fluticasone Propionate Emulsion (0.05%): an Advance in Topical Preparations in the Treatment of Atopic Dermatitis. Poster P717]