Daily application of fluocinonide 0.1% cream for the treatment of atopic dermatitis

Abstract

Objective: To assess the efficacy and safety of topical fluocinonide 0.1% cream for the treatment of atopic dermatitis.

Design: In this double-blind, vehicle-controlled study, patients were randomized to receive treatment with fluocinonide 0.1% cream applied once (n=109) or twice daily (n=102) or vehicle applied once (n=50) or twice daily (n=52) for two weeks.

Setting: Multicenter, outpatient.

Participants: Patients aged 18 years or older with atopic dermatitis affecting at least two percent but less than 10 percent of body surface area.

Measurements: Efficacy and safety measures included lesion severity, pruritus, hypothalamic-pituitary-adrenal axis suppression, and adverse events.

Results: Fluocinonide 0.1% cream applied once or twice daily was more effective than cream vehicle. Both regimens were similarly efficacious after two weeks of treatment. At the end of treatment, lesions were cleared or almost cleared in 59 percent of subjects treated once daily and 57 percent of subjects treated twice daily with fluocinonide 0.1% cream. Further, considerable residual benefit remained after cessation of twice-daily versus once-daily treatment. Skin safety evaluations showed no significant adverse effects of treatment on signs or symptoms of skin atrophy. Fluocinonide 0.1% cream and vehicle treatments did not differ significantly in their suppression of the hypothalamic-pituitary-adrenal axis, nor did hypothalamic-pituitary-adrenal axis suppression differ significantly following once- or twice-daily treatment with fluocinonide 0.1% cream. Fluocinonide 0.1% cream was well tolerated.

Conclusion: Once- or twice-daily topical application of fluocinonide 0.1% cream for 14 days was safe and effective for treating atopic dermatitis in this adult patient population. The efficacy of once-daily application was comparable to twice-daily application.

Figure 1

Treatment success based on dichotomized physician global assessment. FLU QD=fluocinonide cream 0.1% once daily; VEH QD=cream vehicle once daily; FLU BID=fluocinonide cream 0.1% twice daily; VEH BID=cream vehicle twice daily. Statistically significant difference between FLU QD and VEH QD (p<0.001) and FLU BID and VEH BID (p<0.001).

Figure 2

Change in physician global assessment of overall lesions. FLU QD=fluocinonide cream 0.1% once daily; VEH QD=cream vehicle once daily; FLU BID=fluocinonide cream 0.1% twice daily; VEH BID=cream vehicle twice daily. *0=cleared, 1=almost cleared, 2=mild, 3=moderate, 4=severe. Statistically significant difference between treatments: FLU QD and FLU BID vs. corresponding vehicle at Weeks 1 and 2; FLU BID at Week 4 (for each, p< 0.05); FLU QD vs. FLU BID at Week 1 and Week 4 (p< 0.05).

Figure 3

Change in symptom severity ratings. FLU QD=fluocinonide cream 0.1% once daily; VEH QD=cream vehicle once daily; FLU BID=fluocinonide cream 0.1% twice daily; VEH BID=cream vehicle twice daily. *Each of 4 symptoms (erythema, induration/papulation, excoriations, lichenification) was rated as 0=cleared, 1=almost cleared, 2=mild, 3=moderate, 4=severe. Maximum possible total score = 12. Statistically significant difference between treatments: FLU QD and FLU BID vs. corresponding vehicle at Weeks 1 and 2 and FLU BID at Week 4 (for each, p<0.05); FLU QD vs. FLU BID at Week 1 and Week 4 (p<0.05).